New clinical trial data sharing principles agreed

Out-Law News | 06 Aug 2013 | 11:22 am | 1 min. read

Two pharmaceutical industry bodies in Europe and the US have agreed on new principles for sharing clinical trial data.

Companies that are members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) or the Pharmaceutical Research and Manufacturers of America (PhRMA) will adhere to the principles from the beginning of next year.

EFPIA and PhRMA represent companies involved in pharmaceutical research and development and manufacturing. EFPIA is a body that brings together 33 different national pharmaceutical industry associations based across Europe as well as a number of individual pharmaceutical businesses.

Under the principles, the EFPIA and PhRMA members will share "patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients" after associated medicines have received regulatory approvals in the EU or US. Access will only be provided to "qualified" researchers "as necessary for conducting legitimate research" and subject to certain conditions.

Those businesses will set up a system for receiving and reviewing requests for the data. Reviews of clinical trial data access requests will be undertaken by dedicated scientific review boards within each company which will be made up, at least partially, with independent scientists or health professionals.

Certain conditions will apply to the publication of clinical trial data under the terms of the principles, including rules aimed at protecting patient privacy.

"Companies will provide access to patient-level data and other clinical trial information consistent with the principle of safeguarding patient privacy; patients’ informed consent provided in relation to their participation in the clinical trial will be respected," according to the principles document published by EFPIA and PhRMA. "Any patient-level data that is shared will be anonymised to protect personally identifiable information. Companies will not be required to provide access to patient-level data, if there is a reasonable likelihood that individual patients could be reidentified."

Those requesting access to clinical trial data will have to provide companies holding the information with details of what they are proposing to research, including the hypothesis to be tested, the rationale behind the planned research as well as any potential conflicts of interest that may arise "including potential competitive use of the data".

EFPIA and PhRMA members will publish at least the "synopses of clinical study reports" within "a reasonable period of time" after applications to market new medicines are granted by regulators in the EU and US, according to the new principles. In addition, those businesses will be have to assess whether to grant requests for public access to full clinical study reports, including 'patient-level' and 'study-level' data, if the request conditions are met.

EFPIA and PhRMA also announced plans for its members to work with regulators so as to share factual summaries of clinical trial results with patients who participated in the trials.