Clinical Trial Transparency: disclosures for new drugs below ethical and legal standards
In December we surveyed our staff editors, who oversee and manage the peer review process, to tell us about their favourite articles from 2015. Part 2 looks at clinical trial transparency for new drugs.
The ability of medical and healthcare professionals to select the most effective and appropriate treatments for patients depends on an unbiased and scientifically sound evidence base. Clinical trials, particularly randomized controlled trials, are the most rigorous methods for investigating the effectiveness of drugs and other treatments. If clinical trials are not registered or only selectively disseminated then the medical evidence is distorted and clinicians are unable to make informed decisions about which treatments are best for patients. As a result patients may be harmed by taking inferior treatments and participants in clinical trials are not sufficiently protected because they may be unknowingly recruited into a failed experiment that has already been conducted previously but has not been publicly disseminated.
In our second editors’ pick, Jennifer Miller and colleagues examined the levels of clinical trial registration, reporting and publication rates for new drugs approved by the Food and Drug Administration (FDA) in 2012. Out of a total of 318 clinical trials reviewed, 57% were registered per drug on average. 56% of trials were published whilst 65% of trials were either published or had reported results. The authors concluded that disclosures for new drugs frequently fell below the legal requirements and did not meet the ethical standard that results of clinical research should be publicly accessible.
Along these lines, BMJ Open supports editorial policies and procedures that improve clinical trial transparency. These include: (1) our commitment to making all papers accessible to the public; (2) compulsory prospective registration of all clinical trials submitted to the journal in a WHO or ICJME approved registry; (3) the publication of clinical trial protocols and; (4) the publication of negative findings. BMJ is also a founding member of the AllTrials campaign, an initiative specifically set up to improve clinical trial transparency by calling for all past and present clinical trials to be registered and their results reported.