Clinical Trials and Data Transparency - The Public Interest Case: A Briefing Paper

In this paper we were asked to review the draft policy issued recently by the EMA and entitled Publication and access to clinical-trial data. The view taken by the EMA in this draft policy, and the view taken in this paper, is intended to optimise the benefits to public welfare resulting from the creation and publication of clinical trials data, with a particular focus on strengthening the efficient and safe use of existing health technologies and encouraging the development of new ones. In the draft policy, the EMA takes the view that expanding publication and access to detailed clinical trials data will help to resolve scientific logjams or gaps in knowledge on a given medicine or condition, as well as enhancing cooperation in research areas that have been lacking attention. The move towards greater transparency and coordination in the design and conduct of CTs is a worthy goal. The EMA’s initiative represents part of wider efforts to optimise the increasingly complex and costly ecosystem in which R&D in the biopharmaceutical field is carried out. Enhancing the collection and use of clinical trials data will also benefit other siloes of the R&D process, ultimately to the benefit of the public’s welfare. The aspiration to achieve these goals is both merited and valuable. At the same time, it is important to note that at least two other components of the biopharmaceutical R&D environment – maintaining the privacy and confidentiality of patient data and protecting the intellectual property rights and trade secrets generated in the clinical trial phases – are also part of the puzzle. A balance between all of these pieces must be achieved.