Boehringer Ingelheim, Bayer Extend Access To Clinical Trial Data
By Cyndi Root
Boehringer Ingelheim and Bayer have announced plans to share data from clinical trials. Boehringer will provide approved applicants access to all of its studies dating to 1998. Bayer will allow access to data on new medicines and indications approved by the EU and U.S. regulatory agencies on or after January 1, 2014.
Christopher Corsico, global Head of Clinical Development, Medicine, and Regulatory at Boehringer said, “Going beyond applicable regulatory and legal requirements, we at Boehringer Ingelheim feel it is the right approach and hope it will benefit science.” Dr. Joerg Moeller, member of the Bayer HealthCare Executive Committee and head of Global Development said, "Our commitment to clinical trial transparency reflects our will to foster scientific research and hence public health.”
Boehringer Ingelheim
Boehringer Ingelheim stated in a press release that it will make clinical study data available to the scientific community. The move allows researchers to access data via a secure environment. Data will include information on drug development programs and approved products. Interested parties can request materials on the company’s website. An independent external review panel will evaluate information requests. Approved participants must make a data sharing agreement, which would include agreeing to use information for only the study proposal and not to misuse data or contact study participants. Boehringer states that it will protect some information and intellectual property rights. The company intends to provide data as far back as 1998. In addition, the company promises to publish all study outcomes, from that year forward until now, in scientific journals.
Bayer
Bayer HealthCare announced in a press release it will provide qualified researchers access to its clinical studies through an internet portal. In contrast to Boehringer’s offerings, which include all studies, not just those leading to regulatory approval, Bayer will provide studies on approved drugs in the U.S. and Europe. Bayer states that its new program complements the European Medicines Agency’s (EMA’s) efforts to increase clinical trial transparency. Additionally, since Bayer is a member of the pharmaceutical trade associations EFPIA and PhRMA, it wishes to align itself with those associations’ principles on clinical trial data sharing.
Clinical Trial Data Transparency
Boehringer’s and Bayer’s move is part of a growing trend to mine clinical trial data. The Food and Drug Administration (FDA), pharmaceutical companies, and CRO’s are increasingly interested in mining data to make it more transparent for analysis. Drug development is time consuming and costly, so leveraging information assets is becoming critical to success.