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(9):e1000144. Epub 2009/11/11
Dwan K, Gamble C, Williamson PR, Kirkham JJ, Reporting Bias Group. Systematic review of the empirical evidence of study publication bias and outcome reporting bias – an updated review. PLoS One. 2013;8(7):e66844.
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(8):iii, ix-xi, 1–193. Epub 2010/02/26
Cruz ML, Xu J, Kashoki M, Lurie P. Publication and Reporting of the Results of Postmarket Studies for Drugs Required by the US Food and Drug Administration, 2009 to 2013. JAMA Intern Med. 2017;177(8):1207–10.
Jones CW, Handler L, Crowell KE, Keil LG, Weaver MA, Platts-Mills TF. Non-publication of large randomized clinical trials: cross sectional analysis. BMJ. 2013;347:f6104.
Pica N, Bourgeois F. Discontinuation and nonpublication of randomized clinical trials conducted in children. Pediatrics. 2016;138(3)
Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, et al. Consolidated Standards of Reporting Trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012;11:MR000030.
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.
Dechartres A, Trinquart L, Atal I, Moher D, Dickersin K, Boutron I, et al. Evolution of poor reporting and inadequate methods over time in 20 920 randomised controlled trials included in Cochrane reviews: research on research study. BMJ. 2017;357:j2490.
Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of treatment in trials and reviews? BMJ. 2008;336(7659):1472–4.
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 Syst Rev. 2011;1:MR000031.
Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ. 2012;344:d7202.
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(11):e217.
Baudard M, Yavchitz A, Ravaud P, Perrodeau E, Boutron I. Impact of searching clinical trial registries in systematic reviews of pharmaceutical treatments: methodological systematic review and reanalysis of meta-analyses. BMJ. 2017;356:j448.
Jones CW, Keil LG, Holland WC, Caughey MC, Platts-Mills TF. Comparison of registered and published outcomes in randomized controlled trials: a systematic review. BMC Med. 2015;13:282.
Pranic S, Marusic A. Changes to registration elements and results in a cohort of ClinicalTrials.gov trials were not reflected in published articles. J Clin Epidemiol. 2016;70:26–37.
Tang E, Ravaud P, Riveros C, Perrodeau E, Dechartres A. Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles. BMC Med. 2015;13:189.
Chalmers I. Underreporting research is scientific misconduct. JAMA. 1990;263(10):1405–8.
Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gotzsche PC, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet. 2014;383(9913):257–66.
Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014;383(9913):267–76.
Maund E, Tendal B, Hrobjartsson A, Jorgensen KJ, Lundh A, Schroll J, et al. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications. BMJ. 2014;348:g3510.
Simes R. Publication bias: the case for an international registry of clinical trials. J Clin Oncol. 1986;4(10):1529–41.
Meinert CL. Toward prospective registration of clinical trials. Control Clin Trials. 1988;9(1):1–5.
Chalmers TC. Randomize the first patient! N Engl J Med. 1977;296(2):107.
Levine J, Guy W, Cleary PA. Therapeutic trials of psychopharmacologic agents: 1968–1972. In: McMahon FG, editor. Principles and techniques of human research and therapeutics. VIII. Mt. Kisco: Futura Publishing Co; 1974. p. 31–51.
Dickersin K, Rennie D. The evolution of trial registries and their use to assess the clinical trial enterprise. JAMA. 2012;307(17):1861–4.
Dickersin K, Rennie D. Registering clinical trials. JAMA. 2003;290(4):516–23.
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(9):852–60. Epub 2011/03/04
De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. JAMA. 2005;293(23):2927–9.
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(11):1363–4.
121 Stat. 823. Food and Drug Administration Amendments Act (FDAAA) of 2007. Public Law 110–85.
45 CFR 102.3. Adjustment of civil monetary penalties for inflation. Federal Register.
Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials.gov — The Final Rule. N Engl J Med. 2016;375:1998.
42 CFR 11. Clinical trials registration and results information submission; Final rule. Federal Register.
Hudson KL, Lauer MS, Collins FS. Toward a new era of trust and transparency in clinical trials. JAMA. 2016;316(13):1353–4.
NOT-OD-16-149. National Institutes of Health. NIH policy on dissemination of NIH-funded clinical trial information. Federal Register.
Zarin DA, Tse T, Williams RJ, Rajakannan T. Update on trial registration 11 years after the ICMJE policy was established. N Engl J Med. 2017;376(4):383–91.
Law MR, Kawasumi Y, Morgan SG. Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. Health Aff (Millwood). 2011;30(12):2338–45.
Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ. 2012;344:d7373.
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.
Piller C. Law ignored, patients at risk. STAT December 15, 2015. https://www.statnews.com/2015/12/13/clinical-trials-investigation/. Accessed 24 Oct 2017.
Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, et al. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ. 2016;352:i637.
Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015;372(11):1031–9.
Zarin DA, Tse T, Ross JS. Trial-results reporting and academic medical centers. N Engl J Med. 2015;372(24):2371–2.
TranspariMED. Medical Research Ethics at Top UK Universities: Performance, Policies and Future Plans. 2017 Accessed 21 Aug 2017. https://docs.wixstatic.com/ugd/01f35d_15c506da05e4463ca8bd70c2b45bb359.pdf. Report No.
Piller C, Bronshtein T. Faced with public pressure, research institutions step up reporting of clinical trial results. STAT January 9, 2018. https://www.statnews.com/2018/01/09/clinical-trials-reporting-nih/. Accessed 13 Feb 2018.
Weber WE, Merino JG, Loder E. Trial registration 10 years on. BMJ. 2015;351:h3572.
Dal-Re R, Ross JS, Marusic A. Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting. J Clin Epidemiol. 2016;75:100–7.
Scott A, Rucklidge JJ, Mulder RT. Is mandatory prospective trial registration working to prevent publication of unregistered trials and selective outcome reporting? An observational study of five psychiatry journals that mandate prospective clinical trial registration. PLoS One. 2015;10(8):e0133718.
Cybulski L, Mayo-Wilson E, Grant S. Improving transparency and reproducibility through registration: the status of intervention trials published in clinical psychology journals. J Consult Clin Psychol. 2016; https://doi.org/10.1037/ccp0000115.
Viergever RF, Karam G, Reis A, Ghersi D. The quality of registration of clinical trials: still a problem. PLoS One. 2014;9(1):e84727.
Huic M, Marusic M, Marusic A. Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy. PLoS One. 2011;6(9):e25258.
Maruani A, Boutron I, Baron G, Ravaud P. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial. BMJ. 2014;349:g5579.
Huang GD, Altemose JK, O'Leary TJ. Public access to clinical trials: lessons from an organizational implementation of policy. Contemp Clin Trials. 2017;57:87–9.
O'Reilly EK, Hassell NJ, Snyder DC, Natoli S, Liu I, Rimmler J, et al. ClinicalTrials.gov reporting: strategies for success at an academic health center. Clin Transl Sci. 2015;8(1):48–51.
Evoniuk G, Mansi B, DeCastro B, Sykes J. Impact of study outcome on submission and acceptance metrics for peer reviewed medical journals: six year retrospective review of all completed GlaxoSmithKline human drug research studies. BMJ. 2017;357:j1726.
Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, et al. Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors. JAMA. 2017;317:2491–2.
ICH. Guideline for good clinical practice. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Geneva: ICH Expert Working Group; 1996.
46.102(g) C. Protection of Human Subjects. Code of Federal Regulations.
56.102 C. Institutional Review Boards. Code of Federal Regulations.