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Opening up the conversation on clinical trials data sharing

It has been nearly a year since our industry presented its commitments to data sharing at a conference “A roadmap for sharing clinical trial data”. At the time, we felt it was important to share what the industry was doing to increase responsible data sharing in the public eye. Since then, we have continued to make our voice heard in the debate. Now – like many others – we are eager to see the European Medicines Agency’s final policy on disclosing clinical trial data, which is expected for formal adoption in early October.

In the run up to that point, I believe it is important to keep the conversation going. That’s why EFPIA will be running a series of blogs in the coming weeks, inviting a variety of perspectives – from researchers to companies – to share their views on what makes for a “responsible” clinical trial data sharing. We know that everyone does not agree. We saw that at last year’s conference, as the diversity of panelists expressed varied opinions on the topic. Yet, we feel it is important to discuss these differences openly with all stakeholders.

From my side, I am a firm believe in the progress we have already seen made via the EFPIA-PhRMA Commitments for Responsible Trials Data Sharing. This is a proposal for increased data sharing that we believe to be a move towards improved transparency that will benefit everyone from patients to researchers. Three key pillars underlie the proposal: safeguarding the privacy of patients; respecting the integrity of national regulatory systems; and maintaining incentives for investment in biomedical research. Since January, EFPIA and PhRMA Member Companies have been working hard to implement these principles and I am pleased to see the progress that has been made thus far. As an industry want to be held accountable for the commitments we are putting forward.

There is still work to be done, on all sides, and I look forward to the road ahead. In the coming weeks, the different opinions voiced here will offer more valuable insights into how we can best pave the path forward towards a more responsible data sharing. A collaborative effort is needed for success and, for this, we need to ensure that the voices of all relevant stakeholders are heard. This is not only about us; it’s about how our industry interacts with its stakeholders, and how we can best deliver for patients and get researchers the information they need

Richard Bergström

Richard Bergström was appointed as Director General of the European Federation of Pharmaceutical Industries and...
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