Most published randomised trials still not prospectively registered
Widely recognized as key to improving research transparency and accountability, prospective trial registration (that is registration prior to, or no later than 21 days after enrolment of the first participant) can minimize bias from publication and selective outcome reporting, prevent unnecessary duplication of research and facilitate coordination of study efforts. It is also a condition of consideration for publication in numerous journals and has become policy for several funding and regulatory bodies.
Despite this, a recent systematic review analysing almost 9000 RCTs published in medical journals has found that only 53% of published trials from a range of clinical specialties were registered and that only 1 in 5 published RCTs were prospectively registered. Further, among published RCTs that were registered, 65% had been registered retrospectively (after enrollment of first participant) (Trinquart et al. 2018).
The good news was that the proportion of registered trials had significantly increased over time from 25% of trials registered in 2005 to 52% of published trials registered in 2015.
Despite this improvement, the proportion of trials published without prospective registration is still unacceptably high and the fundamental tenant of research transparency severely compromised. Without prospective registration, the number of initiated trials is unknown and with it our ability to assess the total evidence from both reported and unreported trials. Retrospective registration defeats a major purpose of trial registries, and eliminates our ability to assess for selective reporting of outcomes and analyses.
What are the reasons for this concerning situation? Perhaps we could ask the authors of this review, who interestingly did not register their study protocol (though registration of systematic review protocols is not a requirement for consideration for publication, it is a process ‘supported’ by an increasing number of journals, and there is a platform to do so). A recent survey of researchers who had retrospectively registered their interventional studies found lack of awareness the most common reason for not registering prospectively. Participants also indicated linking registration to ethics approval as a strategy to improve compliance. Perhaps this is a way forward.
Trinquart, L., Dunn, A. G., & Bourgeois, F. T. (2018). Registration of published randomized trials: a systematic review and meta-analysis. BMC Med, 16(1), 173. doi: 10.1186/s12916-018-1168-6
The 6th World Conference on Research Integrity (WCRI) to be held on June 2-5, 2019 in Hong Kong. The WCRI is the largest and most significant international conference on research integrity. It has given researchers, teachers, funding agencies, government officials, journal editors, senior administrators, and research students opportunities to share experiences and to discuss and promote integrity in research. The conference is now a biennial event, and the University of Hong Kong and RMIT University in Melbourne, Australia are proud to co-organize the next world conference.
2018 Cochrane-REWARD prize
We are looking for those currently: entries for the 2018 Cochrane-REWARD prize are still open (until the 15th of May). http://www.cochrane.org/news/apply-cochrane-reward-prize-reducing-waste-research Nominations will be assessed against 4 criteria: (1) addresses at least one of the 5 stages of research waste (questions, design, conduct, publication, reporting) in the area of health; (2) pilot or more definitive data showing the initiative can lower waste; (3) The initiative can be scaled up; and (4) the estimated potential reduction in research waste that the initiative might achieve. The prize will be presented at the annual Cochrane Colloquium in Edinburgh (15-18 September).
Rigour mortis: how bad research is killing science
On 26th May 2014, Prof. Malcolm Macleod gave his inaugural lecture at the University of Edinburgh entitled “Rigour mortis: how bad research is killing science”.
Waste in medical academia must be addressed, Chalmers urges in The BMJ Awards acceptance speech
On 8th May 2014, Iain Chalmers, one of the authors of the Lancet series, was presented with the 2014 GSK Lifetime Achievement Award during the BMJ Awards ceremony in London. This award is given to a doctor who has made an outstanding contribution to improving health or healthcare in the UK. It highlights Chalmer’s lifetime commitment to perfect evidence based medicine and improve clinical practice. During his acceptance speech, he said that “medical academia is wasting ‘massive’ amounts of taxpayers’ money, and the public must put it under pressure to change”. He also commended GSK for being the first global company to sign up to the AllTrials campaign and praised the good “moral leadership” of the BMJ on this matter.
Iain Chalmers is a British health services researcher, a founder of the Cochrane Collaboration and coordinator of the James Lind initiative.
Videos from symposium on the Lancet series online
Interview with Paul Glasziou
Accompanying the 2014 series on research in The Lancet is an interview and podcast with Paul Glasziou, Professor of Evidence-Based Medicine at Bond University, Australia. He is a key figure behind The Lancet Series and lead author of one of the articles.
In the interview, Paul Glasziou comments on the background work that led to the series, the future of systematic reviews, and his interest in non-drug research, over-diagnosis and over-detection.
In the podcast he additionally talks about the AllTrials campaign and the importance to register and report all clinical trials.
(Photo © Paul Glasziou/Les Irwig)