The joint principles on “responsible” sharing of clinical-trial data endorsed last July by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) took effect on 1 January 2014.
“Today, EFPIA and PhRMA members are opening a window to new data-sharing requests,” announced Christopher Viehbacher, president of EFPIA and chief executive officer of Sanofi.
Under the joint Principles for Responsible Clinical Trial Data Sharing, researchers may now submit proposals for access to patient-level data, clinical-trial protocols and clinical-study reports for new medicines approved in the US and the European Union after 1 January 2014.
According to the two associations, the Principles will expand “dramatically” the volume of information from clinical trials available to “qualified” researchers as well as patients and members of the public.
Member companies will publish their procedures for requesting clinical-trial data (which some, like GlaxoSmithKline, Pfizer and Roche, have already done) and the industry as a whole will track progress with implementing the Principles, including a report to be issued later this year.
The biopharmaceutical sector’s commitment to data-sharing “provides 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”, EFPIA and PhRMA stated.
Ahead of EMA
The joint Principles come into play ahead of the European Medicines Agency’s (EMA) proposed policy on disclosing clinical-trial data for newly licensed medicines, which is likely to be more permissive than the EFPIA-PhRMA model.
EFPIA has criticised EMA’s proposals on a number of fronts, in particular over commercially confidential information, patient privacy, informed consent, and the need for a robust review-and-appeal system before clinical-trial data are released.
The European agency recently announced that it will not be publishing a definitive policy on data disclosure until at least next March, citing the volume and level of detail in comments received during its public consultation on the proposals.
The original aim was to finalise the disclosure policy before the end of 2013, in time for the planned implementation on 1 January 2014.
Clinical trials regulation
In the meantime, political agreement has been reached on the European Union’s proposed regulation for clinical trials of medicinal products, which includes a number of transparency provisions such as:
Mandatory submission of a results summary, regardless of study outcome, to a publicly accessible EU database within one year of a trial ending.
Submission of a lay summary under the same conditions.
Where the purpose is to obtain a marketing authorisation, applicants must file their clinical-study report to the EU database 30 days after the MA has been granted, the decision-making process on the application completed, or the application withdrawn by the sponsor.
Key points in the EFPIA-PhRMA Principles include:
Patient-level trial data, study-level data, full clinical-study reports and protocols from clinical trials for medicines approved in the US and the EU from 1 January 2014 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 granted access to these data will be expected to publish their findings.
Companies will work with regulators on establishing a mechanism to provide “factual summaries” of clinical-trial results to patients who take part in trials.
The synopses of clinical-study reports trials submitted to the US Food and Drug Administration, the European Medicines Agency or national authorities of EU member states will be made publicly available once a new medicine or new indication is approved.
Companies will publish clinical-trial results regardless of study outcomes. At a minimum, results from all Phase III studies and clinical-trial results “of significant medical importance” should be filed for publication, the Principles stipulate.
Imperative to success
Richard Bergström, director general of EFPIA, said the joint principles had been “welcomed” by the EU’s research community.
According to Robert Hugin, chairman of PhRMA and chairman/chief executive officer of Celgene, the new commitments – which supplement PhRMA’s existing Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results – build on “our ongoing collaboration across the scientific ecosystem” while recognising “the importance of responsibly sharing clinical-trial data in the best interest of patients”.
Imperative to the success of the EFPIA-PhRMA initiative, Hugin added, are “the safeguards that ensure patient privacy, respect the integrity of regulatory systems worldwide and foster ongoing medical innovation”.