Clinical trial transparency reaches record level
Posted: 20 December 2017 | Steve Bremer (European Pharmaceutical Review) | 1 comment
Disclosure rate of industry-sponsored clinical trials at 12 months has significantly improved year on year from 71% in 2009 to 93% in 2014, according to ABPI-sponsored study.
Timely reporting of results from pharmaceutical company-sponsored clinical trials for newly approved medicines has reached its highest recorded level of 93%, according to a study.
The study is the latest in a series covering all trials in patients associated with all 142 new medicines approved by the European Medicine Agency (EMA) over a continuous six-year period (2009-2014). It was sponsored by the Association of the British Pharmaceutical Industry (ABPI) and published in Current Medical Research and Opinion.
Disclosure rate of industry-sponsored clinical trials at 12 months has significantly improved year on year from 71% in 2009 to 93% in 2014. This latest study assessed all completed company-sponsored trials in patients related to all 32 new medicines, licensed to 22 different companies, and approved by the EMA in 2014 and shows that, of the 542 evaluable company-sponsored clinical trials:
- 93% (505) had been disclosed on a registry or in scientific literature within 12 months of first regulatory approval or trial completion
- 96% (518) had results disclosed by the end of the study at 31 July 2016.
The study highlights a number of ways in which disclosure rates could be improved or more easily tracked and accessed in future years:
- Routine inclusion of clinical trial registration numbers in publication abstracts or PubMed indexing in line with ICJME and WHO recommendations to support precise disclosure rates.
- Consideration of the waste of resource associated with the increase in duplication across registries.
- Inclusion of a standard component of the due diligence process when licensing or acquisition deals are in negotiation to support simpler tracking of responsibility for publication of clinical trial data.
These and other topics will be the basis of a multi-stakeholder roundtable, hosted by the ABPI, in the New Year considering the next steps in making the results of clinical research more accessible.
It’s encouraging that industry seems to be improving its performance, but this study sets the bar quite low by using disclosure “on a registry or in scientific literature within 12 months of first regulatory approval or trial completion” as the metric.
A more stringent metric, in line with WHO best practice and transparency benchmarks set out in a recent study by TranspariMED, Transparency International and Cochrane, would be disclosure “on a WHO-approved primary registry within 12 months of a trial’s primary end point”.
The latter study also highlights that pharma companies usually still refuse to disclose Clinical Study Reports (CSRs), which are indispensable for gaining an in-depth understanding of a trial’s conduct and outcomes.
WHO best practice:
http://www.who.int/ictrp/results/jointstatement/en/
Study setting out transparency benchmarks:
https://www.transparimed.org/single-post/2017/12/14/New-study-documents-the-harm-caused-by-evidence-distortion-in-medical-research
In conclusion, this is good news AND there is still a long way to go.