Pharmaceutical industry trade bodies in the EU (EFPIA) and USA (PhRMA) have published a joint statement setting out their principles of responsible data sharing for clinical research.
Under the new commitments, biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients, and members of the public.
- Patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and European Union will be shared with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information. Researchers who obtain such clinical trial data will be encouraged to publish their findings.
- Companies will work with regulators to provide a factual summary 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 Food and Drug Administration, European Medicines Agency (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 clinical trial results regardless of the outcome. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication.
This comes at a time when the EMA guidelines on data release are still under public consultation, but it is not clear whether this week’s statement goes any further than the system that is expected to come into place from 2014.
The announcement comes days after an EFPIA email was leaked by The Guardian newspaper, setting out a proposed strategy that includes “mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data“. This proposal was attacked by the AllTrials.Net campaign, and representatives of both GSK and Roche were reported to have distanced themselves from the strategy.