EFPIA today announced an update on industry progress made on the EFPIA-PhRMA Principles for Responsible Clinical Trials Data Sharing. The update was presented at the DIA EuroMeeting 2014 conference in Vienna, by Richard Bergstrom, EFPIA Director General.
The EFPIA-PhRMA Principles were established with the intent of creating a
common baseline for data sharing that all EFPIA and PhRMA member companies
can agree to. Progress made thus far includes:
Speaking about the progress, Richard Bergstrom, EFPIA Director General said: “The pharmaceutical industry is committed to, and delivering, increased sharing of its clinical trials data to advance public health goals and achieve the best end results for patients. It is working in partnership with stakeholders to make sure this continues to happen in a responsible way.”
The announcement comes during the week the European Medicines Agency (EMA) announced it was continuing the consultation of its draft policy on publication and access to clinical trial data. The final policy and an implementation plan will be presented to the EMA Management Board for endorsement at its June 2014 meeting.
January 2014 this year saw the new industry principles for Responsible Clinical Trial Data Sharing come into force. As a result of these new measures, researchers are now able to submit proposals to receive access to patient level data, protocols, and clinical study reports for new medicines approved in the US and EU after January 1, 2014.
These commitments to data sharing provide new avenues for the scientific community and patients to benefit from clinical research, while maintaining patient privacy, the integrity of national regulators, and incentives for companies to make long-term investments in biomedical research.