Nobody has a greater interest in access to clinical trial data than patients. Patients are exposed to the possibility of some risk, small it is hoped, when they enroll in a clinical trial and yet the sponsoring company owns the trial data and decides when, how, whether and to what extent the results are published. As Peter Gotzsche and others have argued, sponsors have a moral obligation to trial participants to ensure that the trial data is used in the best possible way to promote health and reduce harm – and this implies full disclosure of trial results and data.
When trial outcomes are wholly or partly hidden, and when clinical trial data is not subject to full transparency, the best evidence will not be available to treat patients. In these cases there is a clear danger that patients will receive treatments that would not have been provided if the full picture were known. In the worse cases, a company may have information that would discredit a particular treatment but not wish to publish it for commercial reasons. I hope these cases are rare but they do happen, as readers of this blog will know.
I was surprised, then, to find that patient groups are not very vocal or active in demanding full access to clinical trial data. I scanned the websites of the European patients federations affiliated to the European Patients Forum (EPF). Many deal with important issues around informed consent to participation in clinical trials but not with the wider issue of how the results might be used later. (In fairness, some patient groups focus on direct patient support rather than on wider political or policy issues.)
The EPF did cover the issue in its submission on the revision of the Clinical Trials Directive,calling for the publication of all clinical trial results, positive or negative, in the EU Clinical Trials Data Base, and in an understandable and user-friendly way.
Publication of all clinical trial results would be an important step forward, but not enough. Companies would still have enormous power to choose which results to present and how to present them. Access to clinical trial data is essential to bring the full power of science and sound evidence to the treatment of patients.
There are varous partnership platforms and projects between industry and patient organisations, including (at EU level) EPPOSI and EUPATI but they seem to give little attention to the need for publication of all clinical trial results, or better access to clinical trial data.
I hope patient groups will become more assertive on the need for transparency and good science here. ENDAuthor : Jim Murray