Selected Recent Publications

Byrne D, Prendergast C, Fahey T, Moriarty F. Clinical study reports published by the European Medicines Agency 2016-2018: a cross-sectional analysis. BMJ Open 2023; 13(5):e068981. 

Crequit P, Boutron I, Meerpohl J et al. Future of evidence ecosystem series: 2. current opportunities and need for better tools and methods. J Clin Epidemiol 2020;123:143–152. DOI: 10.1016/j.jclinepi.2020.01.023.

Court of Justice of the European Union. The Court confirms the right of access to documents contained in the file of a marketing authorisation application for a medicinal product. PRESS RELEASE No 6/20 Luxembourg, 22 January 2020 Judgments in Case C-175/18 P PTC Therapeutics International Ltd v European Medicines Agency (EMA), and C-178/18 P MSD Animal Health Innovation and Intervet International v European Medicines Agency (EMA)

Pharmaceutical company policies on trial transparency

• Goldacre B, Lane S, Mahtani K R, Heneghan C, Onakpoya I, Bushfield I et al. Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study BMJ 2017; 358 :j3334

Paul Glasziou and Iain Chalmers: Can it really be true that 50% of research is unpublished? BMJ Blog.June 13 2017

ClinicalTrials.gov records contain data on trial design which may not be reported elsewhere

• Scherer RW, Huynh L, Ervin A-M, Taylor J, Dickersin K. ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study. BMC Med Res Methodol. 2013;13: 79.

Sharing clinical trial data

• Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, et al. Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors. Lancet. 2016;387: e9–11.

Failure to report: A STAT investigation. Dec 13 2015. 

• Report of a review investigating how well organisations of all types (public, academic, hospital, nonprofits and companies) have complied with US legislation about the publication of trial results in ClinicalTrials.gov.

Transparency rules lead to large fall in positive trial results, analysis finds. Mayor S. BMJ 2015;351:doi: http://dx.doi.org/10.1136/bmj.h4304. 

Updated review on anti-influenza drugs (including tamiflu). 

• Jefferson T ,Doshi P. Multisystem failure: the story of anti-influenza drugs. BMJ 2014;348:g2263

• Related correspondence

Daniel M. Hartung et al. Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications: Discrepancies Between ClinicalTrials.gov and Peer-Reviewed Publications. Annals of Internal Medicine. 2014 Apr;160(7):477-483.

House of Commons Public Accounts Committee - Thirty-Fifth Report. Dec 2013. Access to clinical trial information and the stockpiling of Tamiflu

Only 50% of registered trials in a sample of 600 trial records on ClinicalTrials.gov had corresponding publications. PLOS medicine Dec 3 2013

Clinical trial data: get them while you can [editorial].  BMJ 2014; 348

Transparency campaigners make gains in clinical trials battle. BMJ 2013; 347

Peter Doshi, Kay Dickersin, David Healy, S Swaroop Vedula, and Tom Jefferson. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ 2013; 346

Analysis finds clinical trials often small, of poor quality An analysis of registered US clinical trials (Califf et al. 2012) has found that many are of poor quality. Sixty-two percent of the trials from 2007-2010 were small (with 100 or fewer participants), and only four percent had enrolled 1,000 or more participants. Seven percent of studies registered between 2007-2010 didn't discuss their purpose, and four percent did not disclose how many participants were enrolled.

The evolution of trial registries and their use to assess the clinical trial enterprise. A review by Dickersin and Rennie (2012) discusses the evolution of  trial registries and the assessment of clinical trials.

The scatter of research: cross sectional comparison of randomised trials and systematic reviews across specialties. A study conducted by Hoffmann et al. (2012) found that the scatter across journals varied greatly for publishing trials and systematic reviews.

Trial registration in Latin America and The Caribbean's: study of randomized trials published in 2010. Research conducted by Reveiz et al. (2012) to study the prevalence of trial registration in randomised controlled trials (RCTs) published in 2010. Reveiz et al. found 526 RCTs from 19 different countries included in the search. Just under 17% of the RCTs were registered in the ICTRP. Only 4% of these trials in the ICTRP were registered.