This list reflects the citations made throughout the SPIRIT 2013 Checklist section of the website, and replicates the published SPIRIT 2013 Explanation & Elaboration paper.
(1) World Medical Association. WMA Declaration of Helsinki – Ethical principles for medical research involving human subjects. 2008. [Cited 2012 Sept 25]. Available from: http://www.wma.net/en/30publications/10policies/b3/index.html
(2) Pildal J, Chan A-W, Hróbjartsson A, Forfang E, Altman DG, Gøtzsche PC. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ 2005;330:1049.
(3) Hróbjartsson A, Pildal J, Chan A-W, Haahr MT, Altman DG, Gøtzsche PC. Reporting on blinding in trial protocols and corresponding publications was often inadequate but rarely contradictory. J Clin Epidemiol 2009;62:967-973.
(4) Chan A-W, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004;291:2457-2465.
(5) Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol 2006;24:3933-3938.
(6) Chan A-W, Hróbjartsson A, Jørgensen KJ, Gøtzsche PC, Altman DG. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols. BMJ 2008;337:a2299.
(7) Al-Marzouki S, Roberts I, Evans S, Marshall T. Selective reporting in clinical trials: analysis of trial protocols accepted by the Lancet. Lancet 2008;372:201.
(8) Hernández AV, Steyerberg EW, Taylor GS, Marmarou A, Habbema JD, Maas AI. Subgroup analysis and covariate adjustment in randomized clinical trials of traumatic brain injury: a systematic review. Neurosurgery 2005;57:1244-1253.
(9) Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Ghost authorship in industry-initiated randomised trials. PLoS Med 2007;4:e19.
(10) Gøtzsche PC, Hróbjartsson A, Johansen HK, Haahr MT, Altman DG, Chan A-W. Constraints on publication rights in industry-initiated clinical trials. JAMA 2006;295:1645-1646.
(11) Mhaskar R, Djulbegovic B, Magazin A, Soares HP, Kumar A. Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols. J Clin Epidemiol 2012;65:602-609.
(12) Smyth RM, Kirkham JJ, Jacoby A, Altman DG, Gamble C, Williamson PR. Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ 2011;342:c7153.
(13) Tetzlaff JM, Chan A-W, Kitchen J, Sampson M, Tricco AC, Moher D. Guidelines for randomized controlled trial protocol content: a systematic review. Syst Rev 2012;1:43.
(14) Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K et al. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med 2013. In press (Online First version).
(15) Tetzlaff JM, Moher D, Chan A-W. Developing a guideline for reporting clinical trial protocols: Delphi consensus survey. Trials 2012;13:176.
(16) Moher D, Schulz KF, Simera I, Altman DG. Guidance for developers of health research reporting guidelines. PLoS Med 2010;7:e1000217.
(17) Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869.
(18) Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol 2009;62:e1-34.
(19) Warner Chilcott. A comparison of once a day dose compared to 2 doses/day. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000. [cited 2012 Sept 25]. Available from: http://clinicaltrials.gov/show/NCT00505778 NLM Identifier: NCT00505778.
(20) Dickersin K, Manheimer E, Wieland S, Robinson KA, Lefebvre C, McDonald S. Development of the Cochrane Collaboration’s CENTRAL Register of controlled clinical trials. Eval Health Prof 2002;25:38-64.
(21) Shaw L, Price C, McLure S, Howel D, McColl E, Ford GA. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial [protocol]. Trials 2011;12:152.
(22) Sim I, Chan A-W, Gülmezoglu AM, Evans T, Pang T. Clinical trial registration: transparency is the watchword. Lancet 2006;367:1631-1633.
(23) Dickersin K, Rennie D. Registering clinical trials. JAMA 2003;290:516-523.
(24) Krleža-Jerić K, Chan A-W, Dickersin K, Sim I, Grimshaw J, Gluud C for the Ottawa Group. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ 2005;330:956-958.
(25) DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA 2004;292:1363-1364.
(26) Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009;302:977-984.
(27) Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 2010;153:158-166.
(28) You B, Gan HK, Pond G, Chen EX. Consistency in the analysis and reporting of primary end points in oncology randomized controlled trials from registration to publication: a systematic review. J Clin Oncol 2012;30:210-216.
(29) United States Congress. Food and Drug Administration Amendments Act of 2007, Title VIII, Section 801. Expanded clinical trial registry data bank. 2007. [Cited 2012 Sept 25]. Available from: http://www.govtrack.us/congress/billtext.xpd?bill=h110-3580
(30) European Commission. Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004 (2008/C 168/02). Official Journal of the European Union 2008;51:3-4.
(31) Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F et al. Clinical trial registration. BMJ 2007;334:1177-1178.
(32) Bernhard Nocht Institute for Tropical Medicine. Probiotic saccharomyces boulardii for the prevention of antibiotic-associated diarrhoea (SacBo). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000. [cited 2012 Sept 25]. Available from: http://clinicaltrials.gov/ct2/show/NCT01143272 NLM Identifier: NCT01143272.
(33) Protocol SB-275833/030 – Studies 030A and 030B: Two identical double-blind, double-dummy, multicenter, comparative phase III studies of the safety and efficacy of topical 1% SB-275833, applied twice daily, versus oral Cephalexin, 500 mg in adults, or 12.5 mg/kg (250 mg/5 ml) in children, twice daily, in the treatment of uncomplicated secondarily infected traumatic lesions [protocol]. Version 5 (July 25, 2005). Available from: http://www.spirit-statement.org/wp-content/uploads/2012/12/Protocol-SB-275833.pdf
(34) Effect of tranexamic acid on coagulation in a sample of participants in the WOMAN trial: WOMAN-ETAC study [protocol]. Version 1 (August 3, 2011). [Cited 2012 Sept 25]. Available from:
http://www.thewomantrial.lshtm.ac.uk/Images/WOMAN_ETACprotocol.pdf
(35) Chan A-W, Krleža-Jerić K, Schmid I, Altman DG. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. CMAJ 2004;171:735-740.
(36) Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326:1167-1170.
(37) Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA 2003;290:921-928.
(38) Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003;289:454-465.
(39) Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S. Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second-generation antipsychotics. Am J Psychiatry 2006;163:185-194.
(40) Djulbegovic B, Cantor A, Clarke M. The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials. Account Res 2003;10:301-315.
(41) Etter J-F, Burri M, Stapleton J. The impact of pharmaceutical company funding on results of randomized trials of nicotine replacement therapy for smoking cessation: a meta-analysis. Addiction 2007;102:815-822.
(42) Golder S, Loke YK. Is there evidence for biased reporting of published adverse effects data in pharmaceutical industry-funded studies? Br J Clin Pharmacol 2008;66:767-773.
(43) Min Y-I, Unalp-Arida A, Scherer R, Dickersin K. Assessment of equipoise using a cohort of randomized controlled trials [abstract]. International Congress on Peer Review and Biomedical Publication; 2005 Sept 16-18; Chicago, Illinois, USA 2005.
(44) Yaphe J, Edman R, Knishkowy B, Herman J. The association between funding by commercial interests and study outcome in randomized controlled drug trials. Fam Prac 2001;18:565-568.
(45) Ahmer S, Arya P, Anderson D, Faruqui R. Conflict of interest in psychiatry. Psychiatr Bull 2005;29:302-304.
(46) The Danish National Committee on Biomedical Research Ethics. Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics No 9154, 5 May 2011. 2011. [Cited 2012 Sept 25]. Available from: http://www.cvk.sum.dk/English/guidelinesaboutnotification.aspx
(47) Lester RT, Mills EJ, Kariri A, Ritvo P, Chung M, Jack W, et al. The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol [protocol]. Trials 2009;10:87.
(48) Rennie D, Yank V, Emanuel L. When authorship fails. A proposal to make contributors accountable. JAMA 1997;278:579-585.
(49) Trials. Instructions for authors – study protocols. 2012. [Cited 2012 Sept 25]. Available from: http://www.trialsjournal.com/authors/instructions/studyprotocol#formatting-contributions
(50) Williams H. The Bullous Pemphigoid Steroids and Tetracyclines (BLISTER) Study. A randomised controlled trial to compare the safety and effectiveness of doxycycline (200 mg/day) with prednisolone (0.5 mg/kg/day) for initial treatment of bullous pemphigoid [protocol]. Version 4.0 (July 20, 2011). [Cited 2012 Sept 25]. Available from: http://www.spirit-statement.org/wp-content/uploads/2012/12/Blister-Protocol-v4-20July2011.pdf
(51) Gertel A, Block P, Gawrylewski H-M, Raymond S, Quinn T, Muhlbradt E. CDISC Clinical Research Glossary. Version 8.0. 2009. [Cited 2012 Sept 25]. Available from: http://www.cdisc.org/stuff/contentmgr/files/0/be650811feb46f381f0af41ca40ade2e/misc/cdisc_2009_glossary.pdf
(52) World Health Organization. Operational guidelines for ethics committees that review biomedical research. 2000. [Cited 2012 Sept 25]. Available from: http://www.who.int/tdr/publications/documents/ethics.pdf
(53) World Health Organization. Handbook for good clinical research practice (GCP): Guidance for implementation. 2002. [Cited 2012 Sept 25]. Available from: http://apps.who.int/prequal/info_general/documents/GCP/gcp1.pdf
(54) Pierce MA, Hess EP, Kline JA, Shah ND, Breslin M, Branda ME, et al. The Chest Pain Choice trial: a pilot randomized trial of a decision aid for patients with chest pain in the emergency department [protocol]. Trials 2010;11:57.
(55) Vlad SC, LaValley MP, McAlindon TE, Felson DT. Glucosamine for pain in osteoarthritis: why do trial results differ? Arthritis Rheum 2007;56:2267-2277.
(56) Kjaergard LL, Als-Nielsen B. Association between competing interests and authors’ conclusions: epidemiological study of randomised clinical trials published in the BMJ. BMJ 2002;325:249.
(57) Liss H. Publication bias in the pulmonary/allergy literature: effect of pharmaceutical company sponsorship. Isr Med Assoc J 2006;8:451-454.
(58) Montgomery JH, Byerly M, Carmody T, Li B, Miller DR, Varghese F et al. An analysis of the effect of funding source in randomized clinical trials of second generation antipsychotics for the treatment of schizophrenia. Control Clin Trials 2004;25:598-612.
(59) Perlis RH, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. Am J Psychiatry 2005;162:1957-1960.
(60) Jagsi R, Sheets N, Jankovic A, Motomura AR, Amarnath S, Ubel PA et al. Frequency, nature, effects, and correlates of conflicts of interest in published clinical cancer research. Cancer 2009;115:2783-2791.
(61) Mello MM, Clarridge BR, Studdert DM. Academic medical centers’ standards for clinical-trial agreements with industry. N Engl J Med 2005;352:2202-10.
(62) European Vasculitis Study Group (EUVAS). RITUXVAS Clinical Trial Protocol: An international, randomised, open label trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis [protocol]. Version 1b (November 15, 2005). [Cited 2012 Sept 25]. Available from: http://www.vasculitis.nl/media/documents/rituxvas.pdf
(63) Delgado-Rodriguez M, Ruiz-Canela M, De Irala-Estevez J, Llorca J, Martinez-Gonzalez MA. Participation of epidemiologists and/or biostatisticians and methodological quality of published controlled clinical trials. J Epidemiol Community Health 2001;55:569-572.
(64) Llorca J, Martinez-Sanz F, Prieto-Salceda D, Fariñas-Alvarez C, Chinchon MV, Quinones D et al. Quality of controlled clinical trials on glaucoma and intraocular high pressure. J Glaucoma 2005;14:190-195.
(65) CRASH2 Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage: A large randomised placebo controlled trial among trauma patients with or at risk of significant haemorrhage, of the effects of antifibrinolytic treatment on death and transfusion requirement [protocol]. Version 3 (July 2, 2005). [Cited 2012 Sept 25]. Available from: http://www.crash2.lshtm.ac.uk/
(66) Clarke M. Doing new research? Don’t forget the old. PLoS Med 2004;1:e35.
(67) Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT, Kiauka S et al. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess 1999;3:1-143.
(68) Centre for Reviews and Dissemination. Systematic review of barriers, modifiers and benefits involved in participation in cancer trials. CRD Report 31. York: University of York. 2006.
(69) Tournoux C, Katsahian S, Chevret S, Levy V. Factors influencing inclusion of patients with malignancies in clinical trials. Cancer 2006;106:258-270.
(70) Clarke M, Hopewell S, Chalmers I. Clinical trials should begin and end with systematic reviews of relevant evidence: 12 years and waiting. Lancet 2010;376:20-21.
(71) Canadian Institutes of Health Research. RCT evaluation criteria and headings. 2010. [Cited 2012 Sept 25]. Available from: http://www.cihr.ca/e/39187.html
(72) National Institute for Health Research. Efficacy and mechanism evaluation program. Important information & guidance notes – preliminary application. 2012. [Cited 2012 Sept 25]. Available from: http://www.eme.ac.uk/funding/Researcher-led.asp
(73) Jüni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004;364:2021-2029.
(74) Puhan MA, Vollenweider D, Steurer J, Bossuyt PM, ter Riet G. Where is the supporting evidence for treating mild to moderate chronic obstructive pulmonary disease exacerbations with antibiotics? A systematic review. BMC Med 2008;6:28.
(75) Fergusson D, Glass KC, Hutton B, Shapiro S. Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding? Clin Trials 2005;2:218-229.
(76) Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med 1992;327:248-254.
(77) Robinson KA, Goodman SN. A systematic examination of the citation of prior research in reports of randomized, controlled trials. Ann Intern Med 2011;154:50-55.
(78) Goudie AC, Sutton AJ, Jones DR, Donald A. Empirical assessment suggests that existing evidence could be used more fully in designing randomized controlled trials. J Clin Epidemiol 2010;63:983-991.
(79) Cooper NJ, Jones DR, Sutton AJ. The use of systematic reviews when designing studies. Clin Trials 2005;2:260-264.
(80) Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess 2010;14:iii-193.
(81) Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ 2012;344:d7292.
(82) Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 2009;6:e1000144.
(83) Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: MR000006. DOI:10.1002/14651858.MR000006.pub3.
(84) Chan A-W. Out of sight but not out of mind: how to search for unpublished clinical trial evidence. BMJ 2012;344:d8013.
(85) A phase III multi-centre, randomised, double-blind, double-dummy, comparative clinical study to assess the safety and efficacy of a fixed-dose formulation of oral pyronaridine artesunate (180:60 mg tablet) versus chloroquine (155 mg tablet), in children and adult patients with acute Plasmodium vivax malaria [protocol]. Version 2.0 (March 5, 2007). [Cited 2012 Sept 25]. Available from: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0014501#s5
(86) Dawson L, Zarin DA, Emanuel EJ, Friedman LM, Chaudhari B, Goodman SN. Considering usual medical care in clinical trial design. PLoS Med 2009;6:e1000111.
(87) Van Luijn JCF, Van Loenen AC, Gribnau FWJ, Leufkens HGM. Choice of comparator in active control trials of new drugs. Ann Pharmacother 2008;42:1605-1612.
(88) Johansen HK, Gøtzsche PC. Problems in the design and reporting of trials of antifungal agents encountered during meta-analysis. JAMA 1999;282:1752-1759.
(89) Stang A, Hense H-W, Jöckel K-H, Turner EH, Tramèr MR. Is it always unethical to use a placebo in a clinical trial? PLoS Med 2005;2:e72.
(90) Emanuel EJ, Miller FG. The ethics of placebo-controlled trials — A middle ground. N Engl J Med 2001;345:915-919.
(91) Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epi 1999;52:1143-1156.
(92) Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, Wilson K et al. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol 2006;7:141-148.
(93) Rochon PA, Gurwitz JH, Simms RW. A study of manufacturer supported trials of non-steroidal anti-inflammatory drugs in the treatment of arthritis. Archives of Int Med 1994;9:157-163.
(94) Rutherford BR, Sneed JR, Roose SP. Does study design influence outcome? The effects of placebo control and treatment duration in antidepressant trials. Psychother Psychosom 2009;78:172-181.
(95) Sneed JR, Rutherford BR, Rindskopf D, Lane DT, Sackeim HA, Roose SP. Design makes a difference: a meta-analysis of antidepressant response rates in placebo-controlled versus comparator trials in late-life depression. Am J Geriatr Psychiatry 2008;16:65-73.
(96) Sinyor M, Levitt AJ, Cheung AH, Schaffer A, Kiss A, Dowlati Y et al. Does inclusion of a placebo arm influence response to active antidepressant treatment in randomized controlled trials? Results from pooled and meta-analyses. J Clin Psychiatry 2010;71:270-279.
(97) Tang J-L, Zhan S-Y, Ernst E. Review of randomised controlled trials of traditional Chinese medicine. BMJ 1999;319:160-161.
(98) A phase 3, active (Warfarin) controlled, randomized, double-blind, parallel arm study to evaluate efficacy and safety of Apixaban in preventing stroke and systemic embolism in subjects with nonvalvular atrial fibrillation (ARISTOTLE: Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) [protocol]. Version 4 (August 4, 2010). [Cited 2012 Sept 25]. Available from: http://www.nejm.org/doi/full/10.1056/NEJMoa1107039
(99) Fleming TR. Clinical trials: discerning hype from substance. Ann Intern Med 2010;153:400-406.
(100) Heger U, Voss S, Knebel P, Doerr-Harim C, Neudecker J, Schuhmacher C, et al. Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial [protocol]. Trials 2011;12:245.
(101) Hopewell S, Dutton S, Yu L-M, Chan A-W, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 2010;340:c723.
(102) Dumville JC, Hahn S, Miles JN, Torgerson DJ. The use of unequal randomisation ratios in clinical trials: a review. Contemp Clin Trials 2006;27:1-12.
(103) Gilbody S, Bower P, Torgerson D, Richards D. Cluster randomized trials produced similar results to individually randomized trials in a meta-analysis of enhanced care for depression. J Clin Epidemiol 2008;61:160-168.
(104) Lathyris D, Trikalinos TA, Ioannidis JPA. Evidence from crossover trials: Empirical evaluation and comparison against parallel arm trials. Int J Epidemiol 2007;36:422-430.
(105) Khan KS, Daya S, Collins JA, Walter SD. Empirical evidence of bias in infertility research: overestimation of treatment effect in crossover trials using pregnancy as the outcome measure. Fertil Steril 1996;65:939-945.
(106) Katz J, Finnerup NB, Dworkin RH. Clinical trial outcome in neuropathic pain: relationship to study characteristics. Neurology 2008;70:263-272.
(107) Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. JAMA 2006;295:1147-1151.
(108) Fleming TR, Odem-Davis K, Rothmann MD, Li SY. Some essential considerations in the design and conduct of non-inferiority trials. Clin Trials 2011;8:432-439.
(109) Krysan DJ, Kemper AR. Claims of equivalence in randomized controlled trials of the treatment of bacterial meningitis in children. Pediatr Infect Dis J 2002;21:753-758.
(110) Tinmouth JM, Steele LS, Tomlinson G, Glazier GH. Are claims of equivalency in digestive diseases trials supported by the evidence. Gastroenterol 2004;126:1700-1710.
(111) Kairalla JA, Coffey CS, Thomann MA, Muller KE. Adaptive trial designs: a review of barriers and opportunities. Trials 2012;13:145.
(112) Dragalin V. Adaptive designs: terminology and classification. Drug Inf J 2006;40:425-435.
(113) Project Accept Study Group. Project Accept (HPTN 043): A phase III randomized controlled trial of community mobilization, mobile testing, same-day results, and post-test support for HIV in Sub-Saharan Africa and Thailand [protocol]. Version 2.4 (April 15, 2011). [Cited 2012 Sept 25]. Available from: http://www.hptn.org/research_studies/hptn043.asp
(114) Ford JG, Howerton MW, Lai GY, Gary TL, Bolen S, Gibbons MC et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer 2008;112:228-242.
(115) Elkins JS, Khatabi T, Fung L, Rootenberg J, Johnston SC. Recruiting subjects for acute stroke trials: a meta-analysis. Stroke 2006;37:123-128.
(116) Heo M, Papademetriou E, Meyers BS. Design characteristics that influence attrition in geriatric antidepressant trials: meta-analysis. Int J Geriatr Psychiatry 2009;24:990-1001.
(117) Fabricatore AN, Wadden TA, Moore RH, Butryn ML, Gravallese EA, Erondu NE et al. Attrition from randomized controlled trials of pharmacological weight loss agents: a systematic review and analysis. Obes Rev 2009;10:333-341.
(118) Lemieux J, Goodwin PJ, Pritchard KI, Gelmon KA, Bordeleau LJ, Duchesne T et al. Identification of cancer care and protocol characteristics associated with recruitment in breast cancer clinical trials. J Clin Oncol 2008;26:4458-4465.
(119) Jones R, Jones RO, McCowan C, Montgomery AA, Fahey T, Jones R et al. The external validity of published randomized controlled trials in primary care. BMC Fam Pract 2009;10:5.
(120) Sood A, Knudsen K, Sood R, Wahner-Roedler DL, Barnes SA, Bardia A et al. Publication bias for CAM trials in the highest impact factor medicine journals is partly due to geographical bias. J Clin Epi 2007;60:1123-1126.
(121) Wu T, Li Y, Bian Z, Liu G, Moher D. Randomized trials published in some Chinese journals: how many are randomized? Trials 2009;10:46.
(122) Hotopf M, Lewis G, Normand C. Putting trials on trial–the costs and consequences of small trials in depression: a systematic review of methodology. J Epidemiol Community Health 1997;51:354-358.
(123) Evaluation study of congestive heart failure and pulmonary artery catheterization effectiveness (ESCAPE) [protocol]. Version 3.0 (November 29, 1999). [Cited 2012 Sept 25]. Available from: https://biolincc.nhlbi.nih.gov/studies/escape/?q=escape.
(124) Sandercock P, Lindley R, Wardlaw J, Dennis M, Lewis S, Venables G, et al. The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke [protocol]. Trials 2008;9:37.
(125) Blümle A, Meerpohl JJ, Rücker G, Antes G, Schumacher M, von Elm E. Reporting of eligibility criteria of randomised trials: cohort study comparing trial protocols with subsequent articles. BMJ 2011;342:d1828.
(126) Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials 2009;10:9.
(127) Simpson F, Sweetman EA, Doig GS. Systematic review of techniques and interventions for improving adherence to inclusion and exclusion criteria during enrolment into randomised controlled trials. Trials 2010;11:17.
(128) Rendell JM, Merritt RK, Geddes JR. Incentives and disincentives to participation by clinicians in randomised controlled trials. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: MR000021. DOI: 10.1002/14651858.MR000021.pub3.
(129) Weijer C. “Characterizing the population in clinical trials: barriers, comparability, and implications for review” (1995). Philosophy Publications. Paper 250. [Cited 2012 Sept 25]. Available from: http://ir.lib.uwo.ca/philosophypub/250.
(130) Townsley CA, Selby R, Siu LL. Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol 2005;23:3112-3124.
(131) Uchino K, Billheimer D, Cramer SC. Entry criteria and baseline characteristics predict outcome in acute stroke trials. Stroke 2001;32:909-916.
(132) Van Spall HGC, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA 2007;297:1233-1240.
(133) Shapiro SH, Weijer C, Freedman B. Reporting the study populations of clinical trials. Clear transmission or static on the line? J Clin Epi 2000;53:973-979.
(134) Gandhi M, Ameli N, Bacchetti P, Sharp GB, French AL, Young M et al. Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols. AIDS 2005;19:1885-1896.
(135) Montori VM, Wang YG, Alonso-Coello P, Bhagra S. Systematic evaluation of the quality of randomized controlled trials in diabetes. Diabetes Care 2006;29:1833-1838.
(136) Mitchell SL, Sullivan EA, Lipsitz LA. Exclusion of elderly subjects from clinical trials for Parkinson disease. Arch Neurol 1997;54:1393-1398.
(137) Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ 2009;180:E47-E57.
(138) Blanco C, Olfson M, Goodwin RD, Ogburn E, Liebowitz MR, Nunes EV et al. Generalizability of clinical trial results for major depression to community samples: Results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry 2008;69:1276-1280.
(139) Herland K, Akselsen JP, Skjøonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger “real life” population of patients with obstructive lung disease? Respir Med 2005;99:11-19.
(140) Bartlett C, Doyal L, Ebrahim S, Davey P, Bachmann M, Egger M et al. The causes and effects of socio-demographic exclusions from clinical trials. Health Technol Assess 2005;9:iii-iiv.
(141) Zarin DA, Young JL, West JC. Challenges to evidence-based medicine: a comparison of patients and treatments in randomized controlled trials with patients and treatments in a practice research network. Soc Psychiatry Psychiatr Epidemiol 2005;40:27-35.
(142) Hordijk-Trion M, Lenzen M, Wijns W, de Jaegere P, Simoons ML, Scholte op Reimer WJ et al. Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: results from the Euro Heart Survey on Coronary Revascularization. Eur Heart J 2006;27:671-678.
(143) Kievit W, Fransen J, Oerlemans AJ, Kuper HH, van der Laar MA, de Rooij DJ et al. The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomised controlled trials and clinical practice. Ann Rheum Dis 2007;66:1473-1478.
(144) Uijen AA, Bakx JC, Mokkink HG, van Weel C. Hypertension patients participating in trials differ in many aspects from patients treated in general practices. J Clin Epi 2007;60:330-335.
(145) Crossman DC, Morton AC, Gunn JP, Greenwood JP, Hall AS, Fox KA, et al. Investigation of the effect of Interleukin-1 receptor antagonist (IL-1ra) on markers of inflammation in non-ST elevation acute coronary syndromes (The MRC-ILA-HEART Study) [protocol]. Trials 2008;9:8.
(146) Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of treatment in trials and reviews? BMJ 2008;336:1472-1474.
(147) Duff JM, Leather H, Walden EO, LaPlant KD, George TJ, Jr. Adequacy of published oncology randomized controlled trials to provide therapeutic details needed for clinical application. J Natl Cancer Inst 2010;102:702-705.
(148) Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009;374:86-89.
(149) Glasziou P, Chalmers I, Altman DG, Bastian H, Boutron I, Brice A et al. Taking healthcare interventions from trial to practice. BMJ 2010;341:c3852.
(150) Golomb BA, Erickson LC, Koperski S, Sack D, Enkin M, Howick J. What’s in placebos: who knows? Analysis of randomized, controlled trials. Ann Intern Med 2010;153:532-535.
(151) Medical Research Council Working Party on Prostate Cancer. MRC PR05. A Medical Research Council randomised trial of adjuvant sodium clodronate in patients commencing or responding to hormone therapy for metastatic prostate adenocarcinoma [protocol]. Feb 1995 version. [Cited 2012 Sept 25]. Available from: http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=60
(152) Panel on Handling Missing Data in Clinical Trials, National Research Council. The Prevention and Treatment of Missing Data in Clinical Trials. Washington D.C.: The National Academies Press; 2010.
(153) Buchbinder S, Liu A, Thompson M, Mayer K. Phase II extended safety study of Tenofovir Disoproxil Fumarate (TDF) among HIV-1 negative men [protocol]. Version 1.6 (February 16, 2007). [Cited 2012 Sept 25]. Available from: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0023688
(154) World Health Organization. Adherence to long-term therapies: evidence for action. 2012. [Cited 2012 Sept 25]. Available from: http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf
(155) Osterberg L, Blaschke T. Adherence to medication. N Engl J Med 2005;353:487-97.
(156) Smith D. Patient nonadherence in clinical trials: could there be a link to postmarketing patient safety? Drug Inf J 2012;46:27-34.
(157) Robiner WN. Enhancing adherence in clinical research. Contemp Clin Trials 2005;26:59-77.
(158) Matsui D. Strategies to measure and improve patient adherence in clinical trials. Pharmaceut Med 2009;23:289-297.
(159) Simpson SH, Eurich DT, Majumdar SR, Padwal RS, Tsuyuki RT, Varney J et al. A meta-analysis of the association between adherence to drug therapy and mortality. BMJ 2006;333:15.
(160) International Conference on Harmonisation. ICH Harmonised Tripartite Guideline: Good clinical practice, consolidated guideline. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (June 1996, E6). 1996. [Cited 2012 Sept 25]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf
(161) Jayaraman S, Rieder MJ, Matsui DM. Compliance assessment in drug trials: has there been improvement in two decades? Can J Clin Pharmacol 2005;12:e251-e253.
(162) Sackett DL. Clinician-trialist rounds: 5. Cointervention bias–how to diagnose it in their trial and prevent it in yours. Clin Trials 2011;8:440-442.
(163) Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database–update and key issues. N Engl J Med 2011;364:852-860.
(164) Bhandari M, Lochner H, Tornetta P, III. Effect of continuous versus dichotomous outcome variables on study power when sample sizes of orthopaedic randomized trials are small. Arch Orthop Trauma Surg 2002;122:96-98.
(165) Verhagen AP, de Vet HCW, Willemsen S, Stijnen T. A meta-regression analysis shows no impact of design characteristics on outcome in trials on tension-type headaches. J Clin Epi 2008;61:813-818.
(166) Hróbjartsson A, Thomsen AS, Emanuelsson F, Tendal B, Hilden J, Boutron I et al. Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors. BMJ 2012;344:e1119.
(167) Savović J, Jones HE, Altman DG, Harris RJ, Jüni P, Pildal J et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med 2012;157:429-438.
(168) Ferreira-González I, Busse JW, Heels-Ansdell D, Montori VM, Akl EA, Bryant DM et al. Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. BMJ 2007;334:786.
(169) Montori VM, Permanyer-Miralda G, Ferreira-González I, Busse JW, Pacheco-Huergo V, Bryant D et al. Validity of composite end points in clinical trials. BMJ 2005;330:596.
(170) Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA 2003;289:2554-2559.
(171) Cordoba G, Schwartz L, Woloshin S, Bae H, Gøtzsche PC. Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review. BMJ 2010;341:c3920.
(172) Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan A-W, Cronin E et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 2008;3:e3081.
(173) Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: Review of publication and presentation. PLoS Med 2008;5:e217.
(174) Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008;358:252-260.
(175) Vedula SS, Bero L, Scherer RW, Dickersin K. Outcome reporting in industry-sponsored trials of gabapentin for off-label use. N Engl J Med 2009;361:1963-1971.
(176) Dwan K, Altman DG, Cresswell L, Blundell M, Gamble CL, Williamson PR. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: MR000031. DOI: 10.1002/14651858.MR000031.pub2.
(177) Chan A-W. Access to clinical trial data. BMJ 2011;342:d80.
(178) Tugwell P, Boers M, Brooks P, Simon L, Strand V, Idzerda L. OMERACT: an international initiative to improve outcome measurement in rheumatology. Trials 2007;8:38.
(179) Williamson P, Altman D, Blazeby J, Clarke M, Gargon E. Driving up the quality and relevance of research through the use of agreed core outcomes. J Health Serv Res Policy 2012;17:1-2.
(180) Clarke M. Standardising outcomes for clinical trials and systematic reviews. Trials 2007;8:39.
(181) Booth R, Fuller B, Thompson L, McCarty D, Shoptaw S, et al. STUDY #: NIDA-CTN-0017. HIV and HCV risk reduction interventions in drug detoxification and treatment settings [protocol]. Version 4.0 (August 16, 2010). [Cited 2012 Sept 25]. Available from: https://www.dtmi.duke.edu/crflibrary-demo/crf-library-1/crf-library/trials-a-e/ctn-0017
(182) Cockayne NL, Glozier N, Naismith SL, Christensen H, Neal B, Hickie IB. Internet-based treatment for older adults with depression and co-morbid cardiovascular disease: protocol for a randomised, double-blind, placebo controlled trial [protocol]. BMC Psychiatry 2011;11:10.
(183) McMurran M, Crawford MJ, Reilly JG, McCrone P, Moran P, Williams H, et al. Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: A pragmatic multi-site community-based randomised clinical trial [protocol]. Trials 2011;12:198.
(184) van der Lee JH, Wesseling J, Tanck MW, Offringa M. Efficient ways exist to obtain the optimal sample size in clinical trials in rare diseases. J Clin Epidemiol 2008;61:324-330.
(185) Yazici Y, Adler NM, Yazici H. Most tumour necrosis factor inhibitor trials in rheumatology are undeservedly called ‘efficacy and safety’ trials: a survey of power considerations. Rheumatol 2008;47:1054-1057.
(186) Hernández AV, Boersma E, Murray GD, Habbema JD, Steyerberg EW. Subgroup analyses in therapeutic cardiovascular clinical trials: are most of them misleading? Am Heart J 2006;151:257-264.
(187) Copay AG, Subach BR, Glassman SD, Polly DW, Jr., Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J 2007;7:541-546.
(188) Raju TN, Langenberg P, Sen A, Aldana O. How much ‘better’ is good enough? The magnitude of treatment effect in clinical trials. Am J Dis Child 1992;146:407-411.
(189) Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P. Reporting of sample size calculation in randomised controlled trials: review. BMJ 2009;338:b1732.
(190) Vickers AJ. Underpowering in randomized trials reporting a sample size calculation. J Clin Epidemiol 2003;56:717-720.
(191) Proschan MA. Sample size re-estimation in clinical trials. Biom J 2009;51:348-357.
(192) Julious SA, Campbell MJ, Altman DG. Estimating sample sizes for continuous, binary, and ordinal outcomes in paired comparisons: practical hints. J Biopharm Stat 1999;9:241-251.
(193) Campbell MK, Elbourne DR, Altman DG, CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ 2004;328:702-708.
(194) Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW. Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement. JAMA 2006;295:1152-1160.
(195) Pals SL, Murray DM, Alfano CM, Shadish WR, Hannan PJ, Baker WL. Individually randomized group treatment trials: a critical appraisal of frequently used design and analytic approaches. Am J Pub Health 2008;98:1418-1424.
(196) Eldridge S, Ashby D, Bennett C, Wakelin M, Feder G. Internal and external validity of cluster randomised trials: Systematic review of recent trials. Br Med J 2008;336:876-880.
(197) Eldridge SM, Ashby D, Feder GS, Rudnicka AR, Ukoumunne OC. Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care. Clin Trials 2004;1:80-90.
(198) Murray DM, Pals SL, Blitstein JL, Alfano CM, Lehman J. Design and analysis of group-randomized trials in cancer: A review of current practices. J Natl Cancer Inst 2008;100:483-491.
(199) Freiman JA, Chalmers TC, Smith H, Jr., Kuebler RR. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 “negative” trials. N Engl J Med 1978;299:690-694.
(200) Bailey CS, Fisher CG, Dvorak MF. Type II error in the spine surgical literature. Spine 2004;29:1146-1149.
(201) Lochner HV, Bhandari M, Tornetta P, III. Type-II error rates (beta errors) of randomized trials in orthopaedic trauma. J Bone Joint Surg Am 2001;83-A:1650-1655.
(202) Enwere G. A review of the quality of randomized clinical trials of adjunctive therapy for the treatment of cerebral malaria. Trop Med Int Health 2005;10:1171-1175.
(203) Breau RH, Carnat TA, Gaboury I. Inadequate statistical power of negative clinical trials in urological literature. J Urol 2006;176:263-266.
(204) Keen HI, Pile K, Hill CL. The prevalence of underpowered randomized clinical trials in rheumatology. J Rheumatol 2005;32:2083-2088.
(205) Maggard MA, O’Connell JB, Liu JH, Etzioni DA, Ko CY. Sample size calculations in surgery: are they done correctly? Surgery 2003;134:275-279.
(206) Dimick JB, Diener-West M, Lipsett PA. Negative results of randomized clinical trials published in the surgical literature: equivalency or error? Arch Surg 2001;136:796-800.
(207) Murray GD. Research governance must focus on research training. BMJ 2001;322:1461-1462.
(208) Asthma Clinical Research Network. Beta Adrenergic Response by Genotype (BARGE) Study Protocol: A study to compare the effects of regularly scheduled use of inhaled albuterol in patients with mild to moderate asthma who are members of two distinct haplotypes expressed at the β2 -adrenergic receptor [protocol]. Version 5.4 (September 23, 1999). [Cited 2012 Sept 25]. Available from: https://biolincc.nhlbi.nih.gov/studies/barge/?q=barge
(209) Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knights R et al. Recruitment to randomised trials: Strategies for trial enrolment and participation study. The STEPS study. Health Technol Assess 2007;11:iii-72.
(210) Wise P, Drury M. Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners. BMJ 1996;313:1245-1248.
(211) Pich J, Carné X, Arnaiz JA, Gómez B, Trilla A, Rodés J. Role of a research ethics committee in follow-up and publication of results. Lancet 2003;361:1015-1016.
(212) Decullier E, Lhéritier V, Chapuis F. Fate of biomedical research protocols and publication bias in France: retrospective cohort study. BMJ 2005;331:19.
(213) Dal-Ré R, Ortega R, Espada J. [Efficiency of investigators in recruitment of patients for clinical trials: apropos of a multinational study]. Med Clin (Barc) 1998;110:521-523.
(214) McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials 2006;7:9.
(215) Charlson ME, Horwitz RI. Applying results of randomised trials to clinical practice: impact of losses before randomisation. Br Med J (Clin Res Ed) 1984;289:1281-1284.
(216) Caldwell PH, Hamilton S, Tan A, Craig JC. Strategies for increasing recruitment to randomised controlled trials: systematic review. PLoS Med 2010;7:e1000368.
(217) Treweek S, Pitkethly M, Cook J, Kjeldstrøm M, Taskila T, Johansen M et al. Strategies to improve recruitment to randomised controlled trials. Cochrane Database of Systematic Reviews 2010, Issue 4. Art. No.: MR000013. DOI: 10.1002/14651858.MR000013.pub5.
(218) Abraham NS, Young JM, Solomon MJ. A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials. Surgery 2006;139:469-483.
(219) Lai GY, Gary TL, Tilburt J, Bolen S, Baffi C, Wilson RF et al. Effectiveness of strategies to recruit underrepresented populations into cancer clinical trials. Clin Trials 2006;3:133-141.
(220) UyBico SJ, Pavel S, Gross CP. Recruiting vulnerable populations into research: a systematic review of recruitment interventions. J Gen Intern Med 2007;22:852-863.
(221) Miller NL, Markowitz JC, Kocsis JH, Leon AC, Brisco ST, Garno JL. Cost effectiveness of screening for clinical trials by research assistants versus senior investigators. J Psychiatr Res 1999;33:81-85.
(222) Tworoger SS, Yasui Y, Ulrich CM, Nakamura H, LaCroix K, Johnston R et al. Mailing strategies and recruitment into an intervention trial of the exercise effect on breast cancer biomarkers. Cancer Epidemiol Biomarkers Prev 2002;11:73-77.
(223) Schroy P.C. 3rd, Glick JT, Robinson P, Lydotes MA, Heeren TC, Prout M et al. A cost-effectiveness analysis of subject recruitment strategies in the HIPAA era: results from a colorectal cancer screening adherence trial. Clin Trials 2009;6:597-609.
(224) Harvey LA, Dunlop SA, Churilov L, Hsueh Y-SA, Galea MP. Early intensive hand rehabilitation after spinal cord injury (“Hands On”): a protocol for a randomised controlled trial [protocol]. Trials 2011;12:14.
(225) Schulz KF, Grimes DA. The Lancet handbook of essential concepts in clinical research. Edinburgh, UK: Elsevier; 2006.
(226) Greenland S. Randomization, statistics, and causal inference. Epidemiol 1990;1:421-429.
(227) Armitage P. The role of randomization in clinical trials. Stat Med 1982;1:345-352.
(228) Odgaard-Jensen J, Vist GE, Timmer A, Kunz R, Akl EA, Schünemann H et al. Randomisation to protect against selection bias in healthcare trials. Cochrane Database of Systematic Reviews 2011, Issue 4. Art. No.: MR000012. DOI: 10.1002/14651858.MR000012.pub3.
(229) Jüni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ 2001;323:42-46.
(230) McEntegart DJ. The pursuit of balance using stratified and dynamic randomization techniques: an overview. Drug Inf J 2003;37:293-308.
(231) Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet 2002;359:515-519.
(232) Altman DG, Bland JM. How to randomise. BMJ 1999;319:703-704.
(233) Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-412.
(234) Kernan WN, Viscoli CM, Makuch RW, Brass LM, Horwitz RI. Stratified randomization for clinical trials. J Clin Epidemiol 1999;52:19-26.
(235) Han B, Enas NH, McEntegart D. Randomization by minimization for unbalanced treatment allocation. Stat Med 2009;28:3329-3346.
(236) Altman DG. Practical statistics for medical research. London, UK: Chapman & Hall/CRC; 1991.
(237) Treasure T, MacRae KD. Minimisation: the platinum standard for trials? Randomisation doesn’t guarantee similarity of groups; minimisation does. BMJ 1998;317:362-363.
(238) Berger VW. Varying the block size does not conceal the allocation. J Crit Care 2006;21:229-230.
(239) Berger VW. Minimization, by its nature, precludes allocation concealment, and invites selection bias. Contemp Clin Trials 2010;31:406.
(240) Abbott JH, Robertson MC, McKenzie JE, Baxter GD, Theis J-C, Campbell AJ, et al. Exercise therapy, manual therapy, or both, for osteoarthritis of the hip or knee: a factorial randomised controlled trial protocol [protocol]. Trials 2009;10:11.
(241) Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet 2002;359:614-618.
(242) Chalmers TC, Levin H, Sacks HS, Reitman D, Berrier J, Nagalingam R. Meta-analysis of clinical trials as a scientific discipline. I: Control of bias and comparison with large co-operative trials. Stat Med 1987;6:315-328.
(243) Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. JAMA 1994;272:125-128.
(244) Herbison P, Hay-Smith J, Gillespie WJ. Different methods of allocation to groups in randomized trials are associated with different levels of bias. A meta-epidemiological study. J Clin Epidemiol 2011;64:1070-1075.
(245) Kunz R, Vist G, Oxman AD. Randomisation to protect against selection bias in healthcare trials. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: MR000012. DOI: 10.1002/14651858.MR000012.pub2.
(246) Klingberg S, Wittorf A, Meisner C, Wölwer W, Wiedemann G, Herrlich, J, et al. Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE study, a multicenter, prospective, single-blind, randomised controlled clinical trial [protocol]. Trials 2010;11:123.
(247) Dalum HS, Korsbek L, Mikkelsen JH, Thomsen K, Kistrup K, Olander M, et al. Illness management and recovery (IMR) in Danish community mental health centres [protocol]. Trials 2011;12:195.
(248) Hróbjartsson A, Gøtzsche PC. Placebo interventions for all clinical conditions. Cochrane Database of Systematic Reviews 2010, Issue 1. Art. No.: CD003974. DOI: 10.1002/14651858.CD003974.pub3.
(249) Tierney JF, Stewart LA. Investigating patient exclusion bias in meta-analysis. Int J Epidemiol 2005;34:79-87.
(250) Nüesch E, Trelle S, Reichenbach S, Rutjes AW, Bürgi E, Scherer M et al. The effects of excluding patients from the analysis in randomised controlled trials: meta-epidemiological study. BMJ 2009;339:b3244.
(251) Schulz KF, Chalmers I, Altman DG. The landscape and lexicon of blinding in randomized trials. Ann Intern Med 2002;136:254-259.
(252) Ballintine EJ. Randomized controlled clinical trial. National Eye Institute workshop for ophthalmologists. Objective measurements and the double-masked procedure. Am J Ophthalmol 1975;79:763-767.
(253) Gøtzsche PC. Blinding during data analysis and writing of manuscripts. Control Clin Trials 1996;17:285-290.
(254) Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH et al. Issues in data monitoring and interim analysis of trials. Health Technol Assess 2005;9:1-238.
(255) Meinert CL. Masked monitoring in clinical trials–blind stupidity? N Engl J Med 1998;338:1381-1382.
(256) Boutron I, Estellat C, Guittet L, Dechartres A, Sackett DL, Hróbjartsson A et al. Methods of blinding in reports of randomized controlled trials assessing pharmacological treatments: a systematic review. PLoS Med 2006;3:e425.
(257) Boutron I, Guittet L, Estellat C, Moher D, Hróbjartsson A, Ravaud P. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments. PLoS Med 2007;4:e61.
(258) Lieverse R, Nielen MM, Veltman DJ, Uitdehaag BM, van Someren EJ, Smit JH et al. Bright light in elderly subjects with nonseasonal major depressive disorder: a double blind randomised clinical trial using early morning bright blue light comparing dim red light treatment. Trials 2008;9:48.
(259) Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM et al. Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials. JAMA 2001;285:2000-2003.
(260) Haahr MT, Hróbjartsson A. Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors. Clin Trials 2006;3:360-365.
(261) Hróbjartsson A, Boutron I. Blinding in randomized clinical trials: imposed impartiality. Clin Pharmacol Ther 2011;90:732-736.
(262) Fergusson D, Glass KC, Waring D, Shapiro S. Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials. BMJ 2004;328:432.
(263) Sackett DL. Clinician-trialist rounds: 6. Testing for blindness at the end of your trial is a mug’s game. Clin Trials 2011;8:674-676.
(264) Schulz KF, Altman DG, Moher D, Fergusson D. CONSORT 2010 changes and testing blindness in RCTs. Lancet 2010;375:1144-1146.
(265) A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of Dronedarone 400mg BID on top of standard therapy in patients with permanent atrial fibrillation and additional risk factors. Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy (PALLAS) [protocol]. Version 1 (February 26, 2010). [Cited 2012 Sept 25]. Available from: http://www.nejm.org/doi/full/10.1056/NEJMoa1109867.
(266) Campbell NL, Khan BA, Farber M, Campbell T, Perkins AJ, Hui SL, et al. Improving delirium care in the intensive care unit: the design of a pragmatic study [protocol]. Trials 2011;12:139.
(267) FSGS – Clinical trial [protocol]. Version 3c (June 20, 2005). [Cited 2012 Sept 25]. Available from: https://clinicalresearch.ccf.org/fsgs/docs/index_docs.html
(268) Lane SJ, Heddle NM, Arnold E, Walker I. A review of randomized controlled trials comparing the effectiveness of hand held computers with paper methods for data collection. BMC Med Inform Decis Mak 2006;6:23.
(269) Bent S, Padula A, Avins AL. Brief communication: Better ways to question patients about adverse medical events: a randomized, controlled trial. Ann Intern Med 2006;144:257-261.
(270) Dale O, Hagen KB. Despite technical problems personal digital assistants outperform pen and paper when collecting patient diary data. J Clin Epidemiol 2007;60:8-17.
(271) Litchfield J, Freeman J, Schou H, Elsley M, Fuller R, Chubb B. Is the future for clinical trials internet-based? A cluster randomised clinical trial. Clin Trials 2005;2:72-79.
(272) Bedard M, Molloy DW, Standish T, Guyatt GH, D’Souza J, Mondadori C et al. Clinical trials in cognitively impaired older adults: home versus clinic assessments. J Am Geriatr Soc 1995;43:1127-1130.
(273) Jasperse DM, Ahmed SW. The Mid-Atlantic Oncology Program’s comparison of two data collection methods. Control Clin Trials 1989;10:282-289.
(274) Basch E, Jia X, Heller G, Barz A, Sit L, Fruscione M et al. Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst 2009;101:1624-1632.
(275) Cohen SB, Strand V, Aguilar D, Ofman JJ. Patient- versus physician-reported outcomes in rheumatoid arthritis patients treated with recombinant interleukin-1 receptor antagonist (anakinra) therapy. Rheumatology (Oxford) 2004;43:704-711.
(276) Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol 2004;22:3485-3490.
(277) Walther B, Hossin S, Townend J, Abernethy N, Parker D, Jeffries D. Comparison of electronic data capture (EDC) with the standard data capture method for clinical trial data. PLoS One 2011;6:e25348.
(278) Kryworuchko J, Stacey D, Bennett C, Graham ID. Appraisal of primary outcome measures used in trials of patient decision support. Patient Educ Couns 2008;73:497-503.
(279) Roberts L, Counsell C. Assessment of clinical outcomes in acute stroke trials. Stroke 1998;29:986-991.
(280) Marshall M, Lockwood A, Bradley C, Adams C, Joy C, Fenton M. Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for schizophrenia. Br J Psychiatry 2000;176:249-252.
(281) Williams GW. The other side of clinical trial monitoring; assuring data quality and procedural adherence. Clin Trials 2006;3:530-537.
(282) Gassman JJ, Owen WW, Kuntz TE, Martin JP, Amoroso WP. Data quality assurance, monitoring, and reporting. Control Clin Trials 1995;16:104S-136S.
(283) Meyerson LJ, Wiens BL, LaVange LM, Koutsoukos AD. Quality control of oncology clinical trials. Hematol Oncol Clin North Am 2000;14:953-71, x.
(284) Fong DYT. Data management and quality assurance. Drug Information Journal 2001;35:839-844.
(285) Knatterud GL, Rockhold FW, George SL, Barton FB, Davis CE, Fairweather WR et al. Guidelines for quality assurance in multicenter trials: a position paper. Control Clin Trials 1998;19:477-493.
(286) Prevention Study Group. HEALTHY primary prevention trial protocol [protocol]. Version 1.4 (July 14, 2008). [Cited 2012 Sept 25]. Available from: http://www.healthystudy.org/
(287) HIV Prevention Trials Network and the International Maternal Pediatric and Adolescent AIDS Clinical Trials Network. HPTN 046: A phase III trial to determine the efficacy and safety of an extended regimen of nevirapine in infants born to HIV-infected women to prevent vertical HIV transmission during breastfeeding [protocol]. Version 3.0 (September 26, 2007). [Cited 2012 Sept 25]. Available from: http://www.hptn.org/research_studies/hptn046.asp
(288) Ioannidis JP, Bassett R, Hughes MD, Volberding PA, Sacks HS, Lau J. Predictors and impact of patients lost to follow-up in a long-term randomized trial of immediate versus deferred antiretroviral treatment. J Acquir Immune Defic Syndr Hum Retrovirol 1997;16:22-30.
(289) Ford ME, Havstad S, Vernon SW, Davis SD, Kroll D, Lamerato L et al. Enhancing adherence among older African American men enrolled in a longitudinal cancer screening trial. Gerontologist 2006;46:545-550.
(290) Couper MP, Peytchev A, Strecher VJ, Rothert K, Anderson J. Following up nonrespondents to an online weight management intervention: Randomized trial comparing mail versus telephone. J Med Internet Res 2007;9:e16.
(291) Renfroe EG, Heywood G, Foreman L, Schron E, Powell J, Baessler C et al. The end-of-study patient survey: methods influencing response rate in the AVID Trial. Control Clin Trials 2002;23:521-533.
(292) Robinson KA, Dennison CR, Wayman DM, Pronovost PJ, Needham DM. Systematic review identifies number of strategies important for retaining study participants. J Clin Epi 2007;60:757-765.
(293) Fleming TR. Addressing missing data in clinical trials. Ann Intern Med 2011;154:113-117.
(294) Liu M, Wei L, Zhang J. Review of guidelines and literature for handling missing data in longitudinal clinical trials with a case study. Pharm Stat 2006;5:7-18.
(295) Wahlbeck K, Tuunainen A, Ahokas A, Leucht S. Dropout rates in randomised antipsychotic drug trials. Psychopharmacology (Berl) 2001;155:230-233.
(296) Kawado M, Hinotsu S, Matsuyama Y, Yamaguchi T, Hashimoto S, Ohashi Y. A comparison of error detection rates between the reading aloud method and the double data entry method. Control Clin Trials 2003;24:560-569.
(297) Day S, Fayers P, Harvey D. Double data entry: what value, what price? Control Clin Trials 1998;19:15-24.
(298) Reynolds-Haertle RA, McBride R. Single vs. double data entry in CAST. Control Clin Trials 1992;13:487-494.
(299) Gibson D, Harvey AJ, Everett V, Parmar MK. Is double data entry necessary? The CHART trials. CHART Steering Committee. Continuous, Hyperfractionated, Accelerated Radiotherapy. Control Clin Trials 1994;15:482-488.
(300) Ioannidis JPA, Evans SJW, Gøtzsche PC, O’Neill RT, Altman DG, Schulz KF et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004;141:781-788.
(301) Schulz KF, Grimes DA. Multiplicity in randomised trials I: endpoints and treatments. Lancet 2005;365:1591-1595.
(302) Tendal B, Nüesch E, Higgins JP, Jüni P, Gøtzsche PC. Multiplicity of data in trial reports and the reliability of meta-analyses: empirical study. BMJ 2011;343:d4829.
(303) Flow Investigators. Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures [protocol]. BMC Musculoskelet Disord 2010;11:85.
(304) Resuscitation Outcomes Consortium Prehospital Resuscitation using an IMpedance valve and Early vs Delayed analysis (ROC PRIMED) Trial. A factorial design of an active impedence threshold valve versus sham valve and analyze later versus analyze early [protocol]. Dec 2006 version. [Cited 2012 Sept 25]. Available from: http://www.nejm.org/doi/full/10.1056/NEJMoa1010821
(305) Boonacker CW, Hoes AW, van Liere-Visser K, Schilder AG, Rovers MM. A comparison of subgroup analyses in grant applications and publications. Am J Epidemiol 2011;174:219-225.
(306) Schulz KF, Grimes DA. Multiplicity in randomised trials II: subgroup and interim analyses. Lancet 2005;365:1657-1661.
(307) Hirji KF, Fagerland MW. Outcome based subgroup analysis: a neglected concern. Trials 2009;10:33.
(308) Sun X, Briel M, Walter SD, Guyatt GH. Is a subgroup effect believable? Updating criteria to evaluate the credibility of subgroup analyses. BMJ 2010;340:c117.
(309) Rothwell PM. Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet 2005;365:176-186.
(310) Yu L-M, Chan A-W, Hopewell S, Deeks JJ, Altman DG. Reporting on covariate adjustment in randomised controlled trials before and after revision of the 2001 CONSORT statement: a literature review. Trials 2010;11:59.
(311) Chen X, Liu M, Zhang J. A note on postrandomization adjustment of covariates. Drug Inf J 2005;39:373-383.
(312) Rochon J. Issues in adjusting for covariates arising postrandomization in clinical trials. Drug Inf J 1999;33:1219-1228.
(313) Mohr JP, Moskowitz A, Ascheim D, Gelijns A, Parides M, et al. A Randomized multicenter clinical trial of Unruptured Brain AVMs (ARUBA): clinical protocol [protocol]. Version 3.0 (October 16, 2008). [Cited 2012 Sept 25]. Available from: http://research.ncl.ac.uk/nctu/ARUBA.html
(314) Abraha I, Montedori A. Modified intention to treat reporting in randomised controlled trials: systematic review. BMJ 2010;340:c2697.
(315) Fergusson D, Aaron SD, Guyatt G, Hébert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. BMJ 2002;325:652-654.
(316) Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 1999;319:670-674.
(317) Akl EA, Briel M, You JJ, Sun X, Johnston BC, Busse JW et al. Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review. BMJ 2012;344:e2809.
(318) Wood AM, White IR, Thompson SG. Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals. Clin Trials 2004;1:368-376.
(319) Fielding S, Fayers P, Ramsay CR. Analysing randomised controlled trials with missing data: Choice of approach affects conclusions. Contemp Clin Trials 2012;33:461-469.
(320) Streiner DL. Missing data and the trouble with LOCF. Evid Based Ment Health 2008;11:3-5.
(321) Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ 2009;338:b2393.
(322) Groenwold RH, Donders AR, Roes KC, Harrell FE, Jr., Moons KG. Dealing with missing outcome data in randomized trials and observational studies. Am J Epidemiol 2012;175:210-217.
(323) Giraudeau B, Ravaud P. Preventing bias in cluster randomised trials. PLoS Med 2009;6:e1000065.
(324) Berger VW. Conservative handling of missing data. Contemp Clin Trials 2012;33:460.
(325) Azuara-Blanco A, Burr JM, Cochran C, Ramsay C, Vale L, Foster P, et al. The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle-closure glaucoma (EAGLE): study protocol for a randomized controlled trial [protocol]. Trials 2011;12:133.
(326) Sydes MR, Altman DG, Babiker AB, Parmar MK, Spiegelhalter DJ, DAMOCLES Group. Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study. Clin Trials 2004;1:48-59.
(327) Floriani I, Rotmensz N, Albertazzi E, Torri V, De Rosa M, Tomino C et al. Approaches to interim analysis of cancer randomised clinical trials with time to event endpoints: a survey from the Italian National Monitoring Centre for Clinical Trials. Trials 2008;9:46.
(328) Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA 2012;307:1838-1847.
(329) Ellenberg SS. Independent data monitoring committees: rationale, operations and controversies. Stat Med 2001;20:2573-2583.
(330) Ellenberg SS, Fleming TR, DeMets DL. Data monitoring committees in clinical trials: a practical perspective. 6 ed. London: Wiley; 2002.
(331) DAMOCLES study group, NHS Health Technology Assessment Programme. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet 2005;365:711-722.
(332) Bakker OJ, van Santvoort HC, van Brunschot S, Ali UA, Besselink MG, et al. Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial [protocol]. Trials 2011;12:73.
(333) DeMets DL, Pocock SJ, Julian DG. The agonising negative trend in monitoring of clinical trials. Lancet 1999;354:1983-1988.
(334) Berry DA. Interim analyses in clinical trials: classical vs. Bayesian approaches. Stat Med 1985;4:521-526.
(335) Pocock SJ. When to stop a clinical trial. BMJ 1992;305:235-240.
(336) Aronson JK, Ferner RE. Clarification of terminology in drug safety. Drug Saf 2005;28:851-870.
(337) Myers MG, Cairns JA, Singer J. The consent form as a possible cause of side effects. Clin Pharmacol Ther 1987;42:250-253.
(338) Wallin J, Sjövall J. Detection of adverse drug reactions in a clinical trial using two types of questioning. Clin Ther 1981;3:450-452.
(339) Gøtzsche PC. Non-steroidal anti-inflammatory drugs. BMJ 2000;320:1058-1061.
(340) Curfman GD, Morrissey S, Drazen JM. Expression of concern reaffirmed. N Engl J Med 2006;354:1193.
(341) Wright JM, Perry TL, Bassett KL, Chambers GK. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001;286:2398-2400.
(342) Crowe BJ, Xia HA, Berlin JA, Watson DJ, Shi H, Lin SL et al. Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team. Clin Trials 2009;6:430-440.
(343) Sherman RB, Woodcock J, Norden J, Grandinetti C, Temple RJ. New FDA regulation to improve safety reporting in clinical trials. N Engl J Med 2011;365:3-5.
(344) Ruiz-Canela M, Martinez-González MA, Gómez-Gracia E, Fernández-Crehuet J. Informed consent and approval by institutional review boards in published reports on clinical trials. N Engl J Med 1999;340:1114-1115.
(345) Breast Cancer International Research Group. BCIRG 006: Multicenter phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC–>T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (Herceptin®) (AC–>TH) and with docetaxel, carboplatin and trastuzumab (TCH) in the adjuvant treatment of node positive and high risk node negative patients with operable breast cancer containing the HER2 alteration [protocol]. Version 5 (June 27, 2008). [Cited 2012 Sept 25]. Available from: http://www.nejm.org/doi/full/10.1056/NEJMoa0910383
(346) Getz KA, Zuckerman R, Cropp AB, Hindle AL, Krauss R, Kaitin KI. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf J 2011;45:265-275.
(347) Decullier E. Lhéritier V, Chapuis F. The activity of French research ethics committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study. BMC Med Ethics 2005;6:e9.
(348) Lösch C, Neuhäuser M. The statistical analysis of a clinical trial when a protocol amendment changed the inclusion criteria. BMC Med Res Methodol 2008;8:16.
(349) U.S. Food and Drug Administration. Code of Federal Regulations, Title 21, Volume 5, 21CFR312.30. 2011.
(350) European Commission. Communication from the Commission — Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial (CT-1) (2010/C 82/01). Official Journal of the European Union 2010;53.
(351) Bond J, Wilson J, Eccles M, Vanoli A, Steen N, Clarke R, et al. Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats [protocol]. BMC Ear, Nose and Throat Disorders 2006;6:13.
(352) Williams CJ, Zwitter M. Informed consent in European multicentre randomised clinical trials – Are patients really informed? Eur J Cancer 1994;30:907-910.
(353) Ryan RE, Prictor MJ, McLaughlin KJ, Hill SJ. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2008, Issue 1. Art.No.: CD003717. DOI: 10.1002/14651858.CD003717.pub2.
(354) Flory J, Emanuel E. Interventions to improve research participants’ understanding in informed consent for research: a systematic review. JAMA 2004;292:1593-1601.
(355) Cohn E, Larson E. Improving participant comprehension in the informed consent process. J Nurs Scholarsh 2007;39:273-280.
(356) Wendler DS. Assent in paediatric research: theoretical and practical considerations. J Med Ethic 2006;32:229.
(357) McRae AD, Weijer C, Binik A, Grimshaw JM, Boruch R, Brehaut JC et al. When is informed consent required in cluster randomized trials in health research? Trials 2011;12:202.
(358) Beskow LM, Friedman JY, Hardy NC, Lin L, Weinfurt KP. Developing a simplified consent form for biobanking. PLoS One 2010;5:e13302.
(359) HIV Prevention Trials Network. HPTN 037: A phase III randomized study to evaluate the efficacy of a network-oriented peer educator intervention for the prevention of HIV transmission among injection drug users and their network members [protocol]. Version 2.0 (October 23, 2003). [Cited 2012 Sept 25]. Available from: http://www.hptn.org/research_studies/hptn037.asp
(360) World Association of Medical Editors Editorial Policy and Publication Ethics Committees. Conflict of interest in peer-reviewed medical journals. 2009. [Cited 2012 Sept 25]. Available from: http://www.wame.org/conflict-of-interest-in-peer-reviewed-medical-journals
(361) Rochon PA, Hoey J, Chan A-W, Ferris LE, Lexchin J, Kalkar SR et al. Financial conflicts of interest checklist 2010 for clinical research studies. Open Med 2010;4:e69-e91.
(362) Drazen JM, de Leeuw PW, Laine C, Mulrow C, DeAngelis CD, Frizelle FA et al. Towards more uniform conflict disclosures: the updated ICMJE conflict of interest reporting form. BMJ 2010;340:c3239.
(363) World Medical Association. WMA statement on conflict of interest. 2012. [Cited 2012 Sept 25]. Available from: http://www.wma.net/en/30publications/10policies/i3/
(364) Lundh A, Krogsbøll LT, Gøtzsche PC. Access to data in industry-sponsored trials. Lancet 2011;378:1995-1996.
(365) Microbicide Trials Network. MTN-003: Phase 2B safety and effectiveness study of tenofovir 1% gel, tenofovir disproxil fumarate tablet and emtricitabine/tenofovir disoproxil fumarate tablet for the prevention of HIV infection in women [protocol]. Version 2.0 (December 31, 2010). [Cited 2012 Sept 25]. Available from: http://www.mtnstopshiv.org/news/studies/mtn003
(366) Richardson HS, Belsky L. The ancillary-care responsibilities of medical researchers. Hastings Center Report 2004;34:25-33.
(367) Belsky L, Richardson HS. Medical researchers’ ancillary clinical care responsibilities. BMJ 2004;328:1494-1496.
(368) Sofaer N, Strech D. Reasons why post-trial access to trial drugs should, or need not be ensured to research participants: A systematic review. Public Health Ethics 2011;4:160-184.
(369) Participants in the 2006 Georgetown University Workshop on the Ancillary-Care Obligations of Medical Researchers Working in Developing Countries. The ancillary-care obligations of medical researchers working in developing countries. PLoS Med 2008;5:e90.
(370) Beta-Blocker Evaluation of Survival Trial (BEST) Protocol [protocol]. Version 1 (June 22, 1999). [Cited 2012 Sept 25]. Available from: https://biolincc.nhlbi.nih.gov/studies/best/.
(371) Mann H. Research ethics committees and public dissemination of clinical trial results. Lancet 2002;360:406-408.
(372) Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 2011;12:249.
(373) Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. Lancet 2004;363:1341-1345.
(374) Cowley AJ, Skene A, Stainer K, Hampton JR. The effect of lorcainide on arrhythmias and survival in patients with acute myocardial infarction: an example of publication bias. Int J Cardiol 1993;40:161-166.
(375) McGauran N, Wieseler B, Kreis J, Schüler YB, Kölsch H, Kaiser T. Reporting bias in medical research – a narrative review. Trials 2010;11:37.
(376) Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ 2012;344:d7202.
(377) Doshi P, Jones M, Jefferson T. Rethinking credible evidence synthesis. BMJ 2012;344:d7898.
(378) Emerson GB, Warme WJ, Wolf FM, Heckman JD, Brand RA, Leopold SS. Testing for the presence of positive-outcome bias in peer review: a randomized controlled trial. Arch Intern Med 2010;170:1934-1939.
(379) Olson CM, Rennie D, Cook D, Dickersin K, Flanagin A, Hogan JW et al. Publication bias in editorial decision making. JAMA 2002;287:2825-2828.
(380) Rochon PA, Sekeres M, Hoey J, Lexchin J, Ferris LE, Moher D et al. Investigator experiences with financial conflicts of interest in clinical trials. Trials 2011;12:9.
(381) Steinbrook R. Gag clauses in clinical-trial agreements. N Engl J Med 2005;352:2160-2162.
(382) McCarthy M. Company sought to block paper’s publication. Lancet 2000;356:1659.
(383) Nathan DG, Weatherall DJ. Academic freedom in clinical research. N Engl J Med 2002;347:1368-1371.
(384) Rennie D. Thyroid storm. JAMA 1997;277:1238-1243.
(385) Flanagin A, Fontanarosa PB, DeAngelis CD. Authorship for research groups. JAMA 2002;288:3166-3168.
(386) Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 2008;299:1800-1812.
(387) Wislar JS, Flanagin A, Fontanarosa PB, DeAngelis CD. Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey. BMJ 2011;343:d6128.
(388) Gøtzsche PC, Kassirer JP, Woolley KL, Wager E, Jacobs A, Gertel A et al. What should be done to tackle ghostwriting in the medical literature? PLoS Med 2009;6:e1000023.
(389) International Committee of Medical Journal Editors. Defining the roles of authors and contributors. [Cited 2017 Sept 19]. Available from: http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html
(390) Matheson A. How industry uses the ICMJE guidelines to manipulate authorship–and how they should be revised. PLoS Med 2011;8:e1001072.
(391) Graf C, Battisti WP, Bridges D, Bruce-Winkler V, Conaty JM, Ellison JM et al. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ 2009;339:b4330.
(392) Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin 2005;21:317-321.
(393) Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Martin R, Luger TM, et al. Protocol for a randomized controlled trial to improve cognitive functioning in older adults: the Iowa Healthy and Active Minds Study [protocol]. BMJ Open 2011;1:e000218.
(394) Chan A-W. Bias, spin, and misreporting: Time for full access to trial protocols and results. PLoS Med 2008;5:e230.
(395) Lassere M, Johnson K. The power of the protocol. Lancet 2002;360:1620-1622.
(396) Wieseler B, Kerekes MF, Vervoelgyi V, McGauran N, Kaiser T. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. BMJ 2012;344:d8141.
(397) Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ 2011;342:d2686.
(398) European Medicines Agency. European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use) (EMA/110196/2006). 2010. [Cited 2012 Sept 25]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/11/WC500099473.pdf
(399) Doshi P, Jefferson T, Del Mar C. The imperative to share clinical study reports: recommendations from the tamiflu experience. PLoS Med 2012;9:e1001201.
(400) Eichler H-G, Abadie E, Breckenridge A, Leufkens H, Rasi G. Open clinical trial data for all? A view from regulators. PLoS Med 2012;9:e1001202.
(401) Committee on Responsibilities of Authorship in the Biological Sciences, National Research Council. Sharing publication-related data and materials: Responsibilities of authorship in the life sciences. Washington, D.C.: National Academies Press; 2003.
(402) Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. Trials 2010;11:9.
(403) Walport M, Brest P. Sharing research data to improve public health. Lancet 2011;377:537-539.
(404) Ross JS, Lehman R, Gross CP. The importance of clinical trial data sharing: toward more open science. Circ Cardiovasc Qual Outcomes 2012;5:238-240.
(405) Vickers AJ. Making raw data more widely available. BMJ 2011;342:d2323.
(406) The Royal Science Policy Centre. Science as an open enterprise. June 2012. [Cited 2012 Sept 25]. Available from: http://royalsociety.org/uploadedFiles/Royal_Society_Content/policy/projects/sape/2012-06-20-SAOE.pdf
(407) Summerskill W, Collingridge D, Frankish H. Protocols, probity, and publication. Lancet 2009;373:992.
(408) Altman D, Furberg C, Grimshaw J, Rothwell P. Trials – using the opportunities of electronic publishing to improve the reporting of randomised trials. Trials 2006;7:6.
(409) Sharing of Materials, Methods, and Data. 2011. [Cited 2012 Sept 25]. Available from: http://www.plosone.org/static/policies.action
(410) Trials. Instructions for authors. Editorial policies. 2012. [Cited 2012 Sept 25]. Available from: http://www.trialsjournal.com/authors/instructions
(411) National Institutes of Health. Final NIH statement on sharing research data. Feb 26, 2003. 2003. [Cited 2012 Sept 25]. Available from: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
(412) Laine C, Goodman SN, Griswold ME, Sox HC. Reproducible research: moving toward research the public can really trust. Ann Intern Med 2007;146:450-453.
(413) BMJ Publishing Group Ltd. Instructions for authors. 2012. [Cited 2012 Sept 25]. Available from: http://bmjopen.bmj.com/site/about/guidelines.xhtml
(414) Sugarman J, McCrory DC, Hubal RC. Getting meaningful informed consent from older adults: a structured literature review of empirical research. J Am Ger Soc 1998;46:517-524.
(415) Paris A, Cracowski JL, Ravanel N, Cornu C, Gueyffier F, Deygas B et al. [Readability of informed consent forms for subjects participating in biomedical research: updating is required]. Presse Med 2005;34:13-18.
(416) Southwest Oncology Group. Chemoprevention of prostate cancer with finasteride (Proscar®) Phase III [protocol]. Aug 2001 version. [Cited 2012 Sept 25]. Available from: http://swog.org/visitors/pcpt/
(417) Schulz KF, Altman DG, Moher D, the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.