Clinical Trials Data Sharing Debate Continues

Conversations continue in Brussels around enhancing ways to share clinical trial data.

Sue Forda, Lilly.jpg

Last week, we attended a European Forum for Good Clinical Practice (EFGCP) multi-stakeholder roundtable on the very subject, specifically in relation to the interests of patients and research. It provided my colleague Sue Forda, VP Global Regulatory Affairs International, the opportunity to reaffirm our industry commitments and relay what Lilly is doing as a company on this important topic.

We have previously blogged about the industry commitments for data sharing, and a couple of weeks ago we made available a neat 'desk keeper' information guide on the subject to aid discussions and provide additional education on clinical trials generally.

As we have said before, at Lilly we have long been champions of transparency. In 2004, we were the first company to voluntarily establish an online database of our clinical study results. We are firmly committed to responsible transparency of clinical research and safety information for the benefit of patients and healthcare professionals. We also recognise that such disclosure is complicated as it must maintain protection for individual patient privacy, intellectual property including commercially confidential information, and contract rights.

The EFGCP issued a press notice shortly after last week's session stating the principle conclusion from the roundtable was that patients have a fundamental right to information about clinical trials - but the way that information is structured needs to be handled in a respectful way. It continued that while there were many differences of approach and emphasis from the different stakeholders at the event- ranging from patients to academics, ethics committees, medical journals, industry and regulators - there was consensus that any process needs to be transparent, with information being provided to bona fide researchers in a structured way. The EFGCP concluded this will inevitably involve a step-by-step approach, requiring dialogue between those who hold the information and those who seek to access it.

And that is precisely what the industry is committed to do.

At the roundtable we were heartened by comments made Fiona Godlee, editor in chief at the British Medical Journal, who said she was delighted to hear what Lilly was doing on clinical trials data transparency. She also stated good work should be celebrated. We agree. After all, there is a lot of good work going on, which is often overlooked because of a lack of trust of the industry at large. As summarized at the event by Laura Batchelor, Director of Fipra International, trust is key: transparency won't go far without trust.

Incidentally, LillyPadEU was cited at the event as a mechanism demonstrating our commitment to transparency, and we will certainly continue to provide updates on industry and Lilly developments on this forum.

You might find the below of interest, taken from our clinical trials 'desk keeper' - a simple overview of how clinical trials fit into the research and development chain.

CT explained.jpg