Are clinical trial data shared sufficiently today? No | BMJ 2013-07-11


Use the link to access the full text article published by BMJ.  "When discussing transparency it is important to be clear on what is being requested, as obfuscation is sometimes used to avoid discussing simple fixes. At stake are four levels of information about trials: (1) knowledge that a trial has been conducted, from a clinical trials register; (2) a brief summary of a trial’s results, in an academic journal article or regulatory summary; (3) longer details about the trial’s methods and results, from a clinical study report where available; (4) individual patient data. The AllTrials campaign calls only for the first three to be published. The status quo is plainly unsatisfactory. The most current review—with no cherry picking permitted—estimates that around half of all trials for the treatments being used today have gone unpublished; and that trials with positive results are twice as likely to be disseminated.1 This is a problem for both industry and academic trials. Although some in industry claim that these problems are in the past, in reality all supposed fixes have failed. In 2005, journal editors passed regulations stating that they would publish only registered trials: the evidence now shows these regulations have been widely ignored.2 In 2007, US legislation was passed requiring all trials since 2008 to post results on within a year of completion: the best published evidence shows this law has been ignored by 60-90% of trials.3 If industry representatives believe these problems have been fixed, they should present published evidence to support their case, with methods and results that are available for public scrutiny. Even if the latest rules on transparency were to be implemented perfectly—starting from now—they would still do nothing to improve the evidence base for the treatments we use today, because they all cover only trials from the past few years. More than 80% of the medicines prescribed this year were generic, and came on the market more than a decade ago. We need the results of trials on these treatments, which are still available, albeit on paper. It is both practical and reasonable to request that these documents should be simply scanned, and shared. The arguments against this level of transparency are conflicted and misguided. John Castellani, of the Pharmaceutical Research and Manufacturers of America (PhRMA), has claimed previously that it’s enough for regulators alone to see all the information on trials, and to see it behind closed doors. But this goes against the fundamental principles of science: we rely on transparency about methods and results, so that every experiment can be double checked and critically appraised ..."


From feeds:

Open Access Tracking Project (OATP) »


oa.medicine oa.comment oa.advocacy oa.pharma oa.biomedicine oa.clinical_trials oa.bmj oa.alltrials

Date tagged:

07/11/2013, 06:47

Date published:

07/11/2013, 02:47