The pharmaceutical industry associations for Europe and the US have moved to recapture the agenda over clinical-data transparency by endorsing joint principles on “responsible sharing” of clinical-trial data.
The initiative by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) comes amid allegations that the associations plan to enlist patient groups in voicing concerns about ‘non-scientific’ re-use of disclosed clinical-trial data.
The joint Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers involve sharing patient-level and study-level clinical-trial data, full clinical-study reports, and protocols from trials approved in the US and the EU, with “qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information (CCI)”.
Researchers given access to these data would also be encouraged to publish their findings.
The joint principles appear to stake out a more restrictive position than the draft policy on access to clinical-trial data put out for consultation by the European Medicines Agency in June.
“These commitments stand as a responsible alternative to other proposals being put forth in the European Union,” commented EFPIA director general Richard Bergström.
Under the EMA’s proposals, which are open for comment until 30 September, clinical-trial data, information or documents not subject to CCI restrictions or safeguards for the protection of personal data (PPD) would be available to download from the EMA website once the agency had published its European public assessment report on an application for centralised marketing authorisation.
Raw clinical-trial data that raised PPD concerns would be subject, under the EMA’s plans, to controlled access involving conditions such as a minimum standard of de-identification and a legally binding data-sharing agreement.
The agency has also promised to “put in place measures to ensure the best-possible protection of public health (and regulatory decisions) against claims resulting from inappropriate analyses” of available clinical-trial data.
Under amendments to the European Commission’s proposed regulation on clinical trials, which is working its way through the European Parliament, sponsors in the EU would have to publish full Clinical Study Reports once a decision had been taken on marketing-authorisation of the relevant medicine.
Enhancing public health
According to EFPIA and PhRMA, the joint principles on clinical-data transparency reinforce the associations’ “long-standing commitment to enhancing public health”.
Bergström said they reflected EFPIA member companies’ “strong support for sharing clinical-trial data to benefit patients and foster scientific discovery in a way that maintains patient privacy, the integrity of regulatory systems, and incentives to invest in biomedical research”.
From a US perspective, the principles supplement PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, which were updated in 2004 and 2009.
The EFPIA and PhRMA commitments “recognise the importance of sharing clinical-trial data in the interest of patients, healthcare and the economy”, commented Robert Hugin, chairman of PhRMA and chairman and chief executive officer of Celgene Corporation.
“Imperative to the success of this initiative are safeguards that ensure patient privacy, respect for integrity of regulatory systems worldwide and greater incentives for more investment in medical innovation,” Hugin added.
Summaries for patients
Along with controlled access to patient-level and study-level clinical-trial data, full clinical-study reports and protocols from trials, the joint principles stipulate that:
- EFPIA and PhRMA member companies will “work with regulators to provide a factual summary of clinical trial results to patients who participate in clinical trials”.
- Synopses of clinical-study reports for trials filed with the Food and Drug Administration, European Medicines Agency or national authorities in EU member states will be made publicly available when a new medicine or indication is approved.
- Companies will publish clinical-trial results regardless of the outcome. At a minimum, results from all Phase III clinical trials and clinical-trial results of “significant medical importance” should be submitted for publication, the associations state.
The joint principles are available online at:
- http://transparency.efpia.eu/responsible-data-sharing; and
The Association of the British Pharmaceutical Industry welcomed the EFPIA-PhRMA agreement, and in particular the commitment to develop a “consistent and objective mechanism” to share patient-level and study-level clinical-trial data with qualified scientific and medical researchers.