Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) jointly announced a set of five principles for responsible clinical trial data sharing.
These principles look to safeguard enhanced data sharing with researchers; enhanced public access to clinical study information; sharing of results with patients who participate in clinical trials; certification procedures for sharing clinical trials information; reaffirmation of previous commitments to publish clinical trial results.
As an industry, it is important we don't shy away from our responsibility to be open and accountable to the public and patients we serve. These new principles provide a solid set of baseline standards to move toward meeting societal expectations. But there is a vital balance to be made here. It is equally important that as an industry we continue to safeguard the privacy of patients, respect the integrity of national regulatory systems, and maintain incentives in biomedical research.
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.
Lilly registers all Lilly-sponsored Phase II, Phase III and Phase IV interventional clinical studies conducted anywhere in the world that were initiated on or after October 15, 2002, on www.clinicaltrials.gov. We also posts the results of all Lilly-sponsored Phase II, Phase III and Phase IV clinical studies of Lilly-marketed products conducted anywhere in the world that were initiated on or after October 15, 2002.
Additionally, Lilly began registering all Phase I clinical studies commencing on or after October 1, 2010. Lilly also provides updates to the European database (www.clinicaltrialsregister.eu) regarding many aspects of clinical research and development, including the location of where clinical studies are being conducted. Lilly also seeks to publish study results - both positive and negative - through other channels, such as peer-reviewed journals and scientific conferences.
I am sure you will agree, that's a lot of data already in the public domain!
While it is important to meet public expectations on data disclosure, as an industry we have a duty to provide a purpose for the information released. There is absolutely no point in greater transparency and disclosure if the information is undecipherable. That would be counterproductive. Arbitrarily releasing information is pointless if it is not going to be used, or worse still left open to misinterpretation. That is why transparency must be responsible and have a point. And that point should always be for the benefit of patients.
At Lilly, we already successfully connect data outside the company to a common purpose, a common good, through various open innovation schemes. The industry must continue to find innovative ways to guarantee successful outcomes from better data sharing, and today's announcement is certainly a great step forward to that goal.