EFPIA welcomes theWorld Health Organization’s Statement on Public Disclosure of Clinical Trial Results and is supportive of its assertion that “the registration of all interventional trials is a scientific, ethical and moral responsibility”.
EFPIA and its member companies are fully committed, under the Joint EFPIA/PhRMA Principles for Responsible Clinical Trial Data Sharing, to clinical trial registration and data transparency (link to page here).
From the EFPIA/PhRMA Principles:
- 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 EU beginning this year 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 expected to publish their findings.
- 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 Food and Drug Administration, European Medicines Agency, or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication.
- Biopharmaceutical companies also reaffirm their commitment to publish clinical trial results regardless of the outcome of the trials. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication.
It is imperative that this initiative strikes a balance between responsible reporting for public health benefit and safeguarding patient confidentiality, respecting the integrity of the regulatory systems worldwide, and maintaining incentives for investments in biomedical research.
The EFPIA/PhRMA Principles complement the already existing EU requirement to register all studies and to publish summary results. Furthermore, EFPIA and its member companies work towards fulfilling the new clinical trials transparency requirements stemming from the European Medicines Agency’s policy 70 on Publication and Access to Clinical-Trial Data and the new EU Clinical Trials Regulation No 536/2014. Ultimately, all these efforts will benefit patients and allow for increased exchange of scientific information to help foster scientific discovery.