July 25 2013 | By Márcio Barra
Following news of the leaked memo from the European Federation of Pharmaceutical Industries and Associations (EFPIA) earlier this week that sparked a wave of controversy, the EFPIA and the U.S.’ Pharmaceutical Research and Manufacturers of America (PhRMA) released their joint set of principles detailing their strategy to allow a more open access to clinical trial data.
Entitled “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers”, the document states that data from clinical trials for medicines will only be shared with qualified scientific and medical researchers upon request. Said data will be subject to measures to protect the privacy of the patients and confidential commercial information, essentially stopping short of full public availability. These measures include the creation of a scientific review board in each company to review data requests and their legitimacy and purpose (e.g description of requested data; the research hypothesis; rationale for the proposed research; the analysis plan, etc). Any patient data that is shared will be anonymized.
Companies will also start to work with regulators to deliver a summary of clinical trial results to patients who participate in clinical trials. Synopses of clinical study reports for clinical trials from both regions will also be made publicly available upon the approval of a new medicine or new indication.
Richard Bergström, Director General of EFPIA stated that “These commitments stand as a responsible alternative to other proposals being put forth in the European Union (EU).”, namely, the EMA’s new draft policy on access and transparency of clinical-trial data that will come into effect on 1 January 2014, which came under fire from both the EFPIA and PhRMA, which, according to a leaked memo released this week by The Guardian, were assembling a counterattack by patient groups.
The principles are set to start being enforced 1 January 2014, the same date as the EMA’s directive, which proposes three levels of access according to the type of data, alongside rules for publication and use. Check the draft directive here.