Recent scandals in the UK and elsewhere have diminished public trust in the clinical research industry. [References were to trials of TGN 1412 ; Vioxx; and Trovan in Africa.]Their emphasis on trial subjects' expectations that they are contributing to science, not just to a commercial project, is a welcome reminder. The authors underline this point later, asserting that their registry proposals
Transparency is the best antidote to such free-floating distrust. Clinical trial registration will allow the necessary tracking of trials to ensure full and unbiased reporting of the results for public benefit.
Individuals voluntarily participate in trials expecting that the results will be used to improve medical knowledge in general, and not only to serve proprietary or commercial interests. These ethical oblibations to the public good are in addition to the obligations to protect individual research participants during a trial (e.g., informed consent), and they extend to all trials regardless of study design or trial population.
are consistent with the Declaration of Helsinki requirement that 'the design of all studies should be publicly available', as well as with the recognition by the Declaration of Helsinki and the Nuremburg Code that the rights of trial participants hold primacy over commercial and career interests.The proposed WHO registry will include early trials (called Phase I and II in the US) as well larger, late-phase trials is important. Their argument was that early-phase trials "are often terminated for economic reasons." But that registration of them will "ensure that information about the risks of new interventions will be publicly available."
The WHO authors found that "arguments for delayed disclosure were neither convincing nor compelling. First, there is a large variation in disclosure practices - some companies disclose all outcomes, some none - raising the question of what disclosure is truly threatening. Second, information that is claimed to be sensitive is often available for a fee through intelligence services readily found on the internet or through trial participants and consumer websites. Finally, there is no convincing evidence that disclosure threatens competition and hence innovation."
This sort of clarity about the integrity of clinical research is welcome. Hopefully, it will get some attention.