Pharma companies operating in Europe and the US are set to share trial data with qualified researchers in response to mounting pressure from transparency campaigners.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the US’ Pharmaceutical Research and Manufacturers of America (PhRMA) released a joint set of principles detailing plans to allow greater access to information from clinical trials, although stopped short of full public availability.
Patient-level data for medicines approved in the US and EU will be shared with “qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information”, said the statement, which comes amid wider moves toward greater transparency in order to better determine if a drug is as effective as its manufacturer claims.
The commitment from EFPIA/ PhRMA is especially timely, considering the leak earlier this week of a much criticised memo from the two trade bodies requesting their members use patient groups to support a campaign against increased access to trial data.
Set to be implemented from January 2014, the Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers states that requests for data will be reviewed by a scientific review board established by each company, which will include independent scientists and/ or healthcare professionals.
Researchers who request data will also be required to submit a research proposal to document the legitimacy of the research question and their qualifications as a researcher, and are encouraged to post the results of any research based on the data obtained.
This is in line with a previously announced commitment from Roche to release all trial data for its controversial influenza drug Tamiflu to health research body Cochrane Collaboration rather than make all data available.
Other principles outlined by the EFPIA and PhRMA include a commitment for companies to work with regulators to provide a summary of clinical trial results to patients who participate in clinical trials in order to improve understanding of the clinical process.
On top of this, companies will be committed to make publically available the synopses of clinical study reports submitted to regulators in Europe and the US upon approval of a new medicine or indication.
Trial failures also feature as part of the principles, and companies are encourage to publish results from all phase III trials, even if they don’t back the effectiveness of a drug.
The EFPIA’s director general Richard Bergström said the commitments offered a “responsible alternative to other proposals being put forth in the EU”.
This includes plans by the European Medicines Agency (EMA) to release clinical trial data on all newly-approved pharmaceutical drugs, which has come under criticism for its potential to undermine the competitiveness of the pharma industry.