Silent takedown of the pharma trials database…and more
Those of you with more than a passing interest in publication bias and other threats to the integrity of the research literature may have noticed the publication of a study in this week’s PLoS Medicine which looks at the effects of such bias on apparent efficacy of antipsychotic drugs. While the article was in press at PLoS Medicine the lead author, Erick Turner, noticed that a database, initially set up by PhRMA (Pharmaceutical Research and Manufacturers of America) to “serve the valuable function of making clinical trial results for many marketed pharmaceuticals more transparent….” had mysteriously disappeared from the internet – thank you for the hat tip to Erick. (The authors had included this database, amongst others, to try to identify all trials conducted on the antipsychotics they investigate in their analysis). Cynical readers can view an example of what the database used to look like at this page through the Internet Archive – the database used to be present at http://www.clinicalstudyresults.org/).
At the time that Clinicalstudyresults.org was set up, PhRMA touted the initiative as an important venture for achieving transparency and access to the results of all phase III and IV studies (both positive and negative) which had been conducted on PhRMA-member company approved drugs. The last version of the clinicalstudyresults.org website in internet archives seems to suggest that PhRMA now views this database as irrelevant, commenting that other databases have “expanded dramatically, including the National Library of Medicine’s www.ClinicalTrials.gov”. However, the clinicalstudyresults.org website is now entirely inaccessible, and previous versions of it available through internet archiving give no obvious information about plans for rehousing data previously held by clinicalstudyresults.org in public repositories. Merck has announced that it will be moving data for its trials from clinicalstudyresults.org to its own website (see notice on Merck’s site). But it’s clear that patients, clinicians and investigators have no guarantee of permanent accessibility of trial results previously housed by clinicalstudyresults.org. In addition, there’s now no way to identify how many trials were previously reported at clinicalstudyresults.org, and for how many the data may be available elsewhere, or indeed, were unique and are now lost from the public domain. Pharma assures us of its ethical credentials but backtracks on its promises of transparency whenever it wants.
Why is this still important? A detailed study published earlier this year in BMJ shows that although in the US there is legislation mandating that, for certain types of study, trial sponsors deposit results in clinicaltrials.gov within a year of completion, compliance is still very poor. For trials falling within the mandatory requirements, only 22% actually had their results deposited in clinicaltrials.gov. This low level of deposition is hugely concerning because timely deposition of data in Clinicaltrials.gov was intended to provide guarantees that findings of all trials would be available in the public domain even if investigators have not been able to publish findings in journal articles. It’s clear that voluntary mechanisms adopted by pharma – and even unenforced government mandates – are not currently solving the perennial problem of publication bias.
Thank you for drawing attention to the low rate of compliance with mandatory reporting of clinical trial results.
I might be confused, but didn’t the BMJ paper you refer to show that compliance with posting clinical trial results was 40% for industry-funded trials, but only 8% for non-industry-funded trials (eg, funded by NIH / academia)? I understood that compliance with results posting was significantly HIGHER if trials were funded by industry (Fisher’s exact test, P=2.2×10−16).
The compliance issue seems to be a problem for many trial researchers, regardless of their funding source. I can’t see the problem being solved without providing researchers with more resources to post trial results in a timely and complete manner.
Professor Karen Woolley
Professional medical writer (NOT a ghostwriter); University of Queensland; University of the Sunshine Coast; ProScribe Medical Communications
Competing interests: I conduct and publish research on ethical medical writing practices. I am actively involved in not-for-profit associations that educate members on ethical publication practices. I am paid to provide ethical medical writing training courses and services for not-for-profit and for-profit clients.
I appreciate your response – yes, the BMJ study appraising deposition of results for registered trials in clinicaltrials.gov did find much better rates of publication for industry-funded trials as compared to mixed-funding trials or government/NIH-funded trials.
So yes, compliance is suboptimal for all trials regardless of funding. (I believe that’s true both for journals publication as well as deposition of data into databases such as clinicaltrials.gov).
All the best,