The Faculty of Pharmaceutical Medicine (FPM) has released a survey of its members’ attitudes about clinical trial transparency. 379 people completed the 24 question survey from the 23rd September to 28th October 2013. Members completing the survey were asked to “respond as pharmaceutical physicians with a duty and responsibility to patients, research subjects and society, and not on behalf of their employing organisations.”
From the results, over 80% of Faculty members believe that increased publication of clinical trial results and greater transparency will lead to better medicine and healthcare, stronger science, and that trial sponsors have a moral duty to make data available. Only 10% of members believe that that increased publication and dissemination of clinical trial results will harm the commercial environment in which companies operate.
But while 95% believe all clinical trials should be registered, only 75% believe it should be mandatory. Furthermore, 57% believe that clinical trials (summary results and methodology) should be published within 1 year of completion (another 16% support publication after longer timeframes). 69% support requiring some historic data being made public, with 45% supporting a requirement for data collected in the past 5 years. Almost 25% say there should be no requirement for release of historic data.
The Faculty also made a number of recommendations in their report on the survey. One recommendation is that all trials be registered before starting and that registration should be a requirement for ethics approval. Another recommendation is that the pharmaceutical industry should publish trial data after trial completion rather than after a product receives regulatory approval or is discontinued. They also recommend that historic data going back at least 5 years should be made public.
Dr Ben Goldacre, author and co-founder of AllTrials:
It is extremely encouraging to see, once again, that so many of the clinicians who work for industry recognise that they have a duty to ensure patients are not harmed by the withholding of important clinical data. However, while there is near universal support for some abstract notion of transparency, the details show a different picture. A quarter of respondents reject the notion of compulsory registration of all trials, leaving the door open for missing data, even though registration has been almost universally recognised as essential throughout the whole of medicine; a quarter reject greater transparency even for the trials of the past, even though these are the trials done on the very medicines we use today; and only half agree to reporting summary methods and results within a year, even though this has been required since 2007 under US legislation (which has been widely ignored).
These issues are the bread and butter of transparency. We cannot make informed decisions about which treatment is best when vitally important information is withheld from doctors and patients. Patients and policy makers cannot be expected to trust the sector, for as long as they continue to defend withholding this information. Industry has nothing to lose, and everything to gain, by entering the 21st century.