GEN Exclusives

More »

GEN News Highlights

More »
Jan 3, 2014

Sanofi Aligns Data Sharing with Industry Groups

  • Sanofi said it will abide by principles for the sharing of clinical data announced this week by U.S. and European biopharma industry groups, one of them led by the company’s CEO. The principles go beyond recent industry norms but fall short of the total open-access sought by Europe’s chief drug regulator and at least one pharma giant.

    Starting this month, Sanofi said, it will provide access to clinical trial data and related documents, including clinical study reports (CSR), for studies sponsored by Sanofi companies that conduct clinical studies in humans. The studies must have been submitted to U.S. and European Union regulatory agencies, and the product supported by the studies must have been approved by both agencies on or after January 1, 2014.

    Sanofi committed itself to continuing to submit for publication results from all company-sponsored clinical studies, regardless of the study outcome. The company also noted that Sanofi and other companies were working with regulators to develop lay-language summary results of studies directly to participants.

    Sanofi’s practices fall in line with those agreed to by the European Federation of Pharmaceutical Industries and Associations (EFPIA)—whose president is Sanofi CEO Christopher A. Viehbacher—and the Pharmaceutical Research and Manufacturers of America (PhRMA).

    “Finding new therapies can be accelerated by fully sharing the successful and unsuccessful research results with other researchers,” Viehbacher said in a Sanofi statement. “Data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers. The private sector has taken a lead on this which I would hope academic researchers will follow.”

    Effective January 1, PhRMA and EFPIA biopharmaceutical companies agreed to increase the amount of information available to researchers, patients, and members of the public. The groups agreed that companies will publish procedures for requesting data, while the industry will track progress toward implementing the principles, in part through a report to be published later this year.

    The EFPIA-PhRMA principles include commitments by companies to:

    • Share, starting this year, 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 the European Union—but only with “qualified scientific and medical researchers” upon request, and subject to terms the groups said were necessary to protect patient privacy and confidential commercial information. However, researchers who obtain access to such clinical trial data will be expected to publish their findings.
    • Work with regulators toward a process of providing factual summaries of clinical trial results to patients who participate in clinical trials.
    • Make publicly available the synopses of clinical study reports for clinical trials in patients submitted to the FDA, the European Medicines Agency (EMA), or national authorities of E.U. member states—but only upon approval of a new medicine or new indication.
    • Reaffirm earlier industry commitments to publish clinical trial results regardless of the outcome of the trials. But the principles offer some room for limiting data disclosure by adding: “At a minimum, results from all Phase III clinical trials and clinical trial results of significant medical importance should be submitted for publication.”

    The EFPIA-PhRMA principles contrast with the open-access stance of the EMA, which in June released a public draft of Policy 70. It requires the same open access through which it has released some two million pages of documents related to agency-approved drugs since 2010.

    The public draft sparked more than 1,000 comments—including criticism from biopharmas that favor more limited data release. The EMA has postponed final action pending discussion of the policy and a companion implementation plan at its March 2014 management board meeting.

    On December 12, the management board approved “key principles” that include step-by-step implementation, starting with preparing for publication of clinical study reports redacted “as appropriate”; developing a methodology for de-identifying patients; and defining a standard format for submitting data.

    The EMA also said it foresees preliminary steps prior to data access designed to address the risk of possible unfair commercial use of data while ensuring proactive and nonselective access. The EMA also reiterated a “firm” commitment to pursuing the objective of full transparency regarding clinical trial data.

    The EMA’s data-sharing stance includes access to the processes by which compounds are manufactured. Viehbacher has criticized the EMA’s stance as promoting too much openness, saying last summer that Sanofi and other companies may cut back investment in Europe in favor of the United States or emerging markets if the EMA should prevail on open access.

    Viehbacher’s predecessor as EFPIA president—Sir Andrew Witty, CEO of GlaxoSmithKline (GSK)—in 2012 committed his company to transparency through open access to clinical trial data. Last May, GSK launched an online system allowing researchers to request access to anonymized patient-level trial data. The following month, AstraZeneca and Roche announced a more limited data-sharing initiative that made selected databases available for study via matched molecular pair analysis that identifies potential structural modifications companies can apply to their compounds to improve metabolism, pharmacokinetics, or safety—without divulging confidential information about those structures.



Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Tackling Climate Change

Do you think most companies will respond positively to the People’s Climate March?