As the European Medicines Agency (EMA) continues the consultation process for its draft policy on publication and access to clinical trial data, the Brussels-based European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a new statement on the EFPIA-PhRMA Principles for Responsible Clinical Trials Data Sharing.
The final policy and an implementation plan is now due to be presented to the EMA Management Board for endorsement at its June 2014 meeting, but Richard Bergstrom, EFPIA Director General, spoke about the issue during this week’s DIA EuroMeeting 2014 conference in Vienna, Austria.
“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,” he said.
The EFPIA-PhRMA Principles were aim to create a common baseline for data sharing that all member companies can agree to. In December 2013, Pfizer revealed its updated policy on clinical trials data sharing, and MSD, Roche, and UCB shared their steps towards implementing the principles in a publicly accessible webinar. In January 2014, Sanofi announced its plans to expand clinical trials data sharing through participation in http://clinicalstudydatarequest.com, a multi-company portal. Other participants in this portal include GSK, Boehringer Ingelheim, and Roche.
In March 2014, 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. Also, Johnson & Johnson’s subsidiary, Janssen Research and Development, LLC, says it will enter an agreement with Yale School of Medicine’s Open Data Access (YODA) Project.
As a result of this progress, researchers can now submit proposals to receive access to patient level data, protocols, and clinical study reports for new medicines approved in the U.S and European Union after January 1, 2014. Furthermore, companies will work with regulators toward a mechanism to provide factual summaries of clinical trial results to patients who participate in clinical trials. The synopses of clinical study reports for clinical trials in patients submitted to the FDA, EMA, or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication.
Biopharmaceutical companies have also reaffirmed their commitment to publish results regardless of the outcome of trials. At a minimum, results from all Phase III clinical trials and clinical trial results of significant medical importance now should be submitted for publication.
Read the full release here.
Download the brochure for the June 9-10th Publication and Clinical Trial Disclosure Event, taking place in Dublin this year