UPDATE: Clinical Data Sharing - Progress Made Against 2013 Commitments

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:

• In December of last year, Pfizer detailed its updated policy on clinical trials data sharing, which expands on previous measures and meets the Principles for Responsible Data Sharing.
• Last December, three EFPIA member companies – MSD, Roche, and UCB – shared their steps towards implementing the Principles in a publicly accessible webinar.

• In January this year, Sanofi announced its plans to expand clinical trials data sharing through participation in http://clinicalstudydatarequest.com, a multi-company portal for clinical trial data sharing. Other companies participating in this portal include GSK, Boehringer Ingelheim, and Roche.
• In March this year, Novo Nordisk launched its new web platform where clinical study reports are now published and through which secondary researchers can seek access to detailed anonymized data upon approval by an independent review board.
• Johnson & Johnson’s announced recently its subsidiary, Janssen Research and Development, LLC, will enter an agreement with Yale School of Medicine’s Open Data Access (YODA) Project, marking yet another valuable milestone in industry’s move towards responsible sharing of clinical trials data.

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.