Contrary to popular belief there is much common ground. On current and future trials the ABPI Code of Practice is clear; all trials must be registered within 21 days of the initiation of patient enrolment and results, positive or negative, must be published within one year of marketing authorisation. On the disclosure of data from past trials, the ABPI supports increasing access to retrospective data but where we differ from the approach suggested on alltrials.net is how this can be achieved.
Our view is that access to data should support clinical decision making and benefit patients and to achieve this we need to ensure that secondary analysis of the data is rigorous and appropriate, with issues such as patient anonymity and commercial confidentiality taken in to account. Rather than releasing vast amounts of data, often relating to medicines long established by the clinical community as safe and effective into public databases, we support the release of clinical trial data on reasonable request, via a transparent and accountable process, as a more pragmatic way forward.
The ABPI supports the European Medicines Agency’s initiative to disclose trial information and the creation of working groups to examine the many complexities in making disclosure feasible. I hope by working together with stakeholders and as part of the global research community we can continue to drive this agenda forward.
ABPI Chief Executive