We believe that greater transparency in clinical trial results and access to trial data is in the best interests of patients and medicine. The pharmaceutical industry has been and continues to be committed to evolving and addressing the issues relating to transparency in clinical research.
The ABPI is actively playing a meaningful role in the discussion. However, clinical research is a truly global process and in this context, the ABPI must consider the evolution at a global level and in partnership with all relevant stakeholders. This process has been advancing rapidly over recent years and continues to progress, evidenced most recently at the European Medicines Agency (EMA) workshop on clinical trials data and transparency which took place on 22 November 2012.
At a European and international level, industry engagement on the issue is co-ordinated by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). You can access the EFPIA position on the issue here and the IFPMA position here (clause 9 of the IFPMA Code).
We are aware that there is a great deal more work to be done to find solutions and we are engaging with European and international colleagues as well as many other stakeholders. This includes the BMJ with whom we recently held an event to gain further perspectives on this issue. We do not have the answers on our own, but our goal is to help find the answers.
There is no doubt that we support enhanced transparency of clinical research and safety information. However, this must be balanced with the need to ensure that disclosure policies protect patients’ personal data, companies’ intellectual property rights and confidential commercial information in order to continue to develop innovative medicines in areas of unmet clinical need.
From HIV to cardiovascular disease, neurological conditions to oncology, the pharmaceutical industry researches, develops and delivers medicines that radically improve the quality of life of patients and their carers. This is vital to ensuring patients have access to the most effective treatments.