Striking a balance in greater clinical trials data sharing

Opinions on how to best increase openness around clinical trials data are varied, but as the conversation has progressed, one thing has become clear: It will be necessary to strike a certain balance if we are to develop data-sharing measures that will best serve public health interests. Greater transparency around clinical trials data is needed – but it must be a responsible transparency. This means protecting not only patients by ensuring their private data is appropriately protected, but also protecting the information contained in clinical trials data that is potentially commercially sensitive. This is a must if we are to safeguard innovation, the tool that the pharmaceutical industry relies on to develop treatments for improved patient outcomes. Publishing Clinical Study Reports (CSRs) in their entirety, as they are written now, does not strike this balance. Making patient-level data available to all does not strike this balance. Allowing indeterminate access to full data sets – again, does not strike this balance. A responsible transparency is one that safeguards patients and their privacy, respects regulatory systems at all levels and protects research incentives. These are the premises underlying the EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing, which EFPIA and PhRMA member companies have agreed to implement from January 1, 2014. These commitments enhance patient and public access to clinical study information by providing synopses of clinical study reports, which give the public information it needs while protecting sensitive patient information. More detailed patient-level and study-level data can be made available on request to those who can do good with it, including qualified researchers who will further science.

In a recent NEJM article (doi: 10.1056/ NEJMp1310771), the EMA’s Hans-Georg Eichler, Guido Rasi and other authors argue that access to patient-level trial data could help drug developers in how they conduct clinical trials – something that could potentially improve healthcare outcomes. Drugmakers have already recognised the value of sharing data with qualified researchers. We are increasingly seeing cases of open innovation and companies that were once competitors joining forces to tackle areas of unmet need. The Innovative Medicines Initiative, the public-private partnership between EFPIA and the European Commission, is fostering open innovation and encouraging collaboration, with companies sharing data and pooling resources. There are undeniable benefits to increasing openness around clinical trials data – but only if it is shared in the right way, with the right people.

Knowledge is power, and this is especially true when it comes to healthcare. The science of medicine has allowed for amazing progress in improving treatment for a variety of illnesses, from HIV to cancer. Medical and scientific innovation is one of the most powerful tools we have for improving patients’ lives. Responsible data-sharing is about recognising this and striking the right balance – one that protects both patients and innovation.

Richard Bergstroem

was appointed Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) in April 2011. Over the past 20 years, he has worked for Roche, Novartis and with the Swedish pharmaceutical industry association (LIF). A pharmacist by training, he received his MScPharm degree from the University of Uppsala (Sweden) in 1988. Since 2006, Bergström has been an advisor to the WHO on Good Governance in Medicine.