Bayer HealthCare extends access to clinical trial data
Bayer HealthCarewill start sharing data from its clinical studies through the internet portal www.clinicalstudydatarequest.com. Qualified researchers can request anonymized patient-level data from Bayer HealthCare sponsored clinical studies listed on the web site.
By joining the portal, Bayer HealthCare is supporting efforts of the EMA to increase the transparency of data from clinical studies. As a member company of pharmaceutical trade associations EFPIA and PhRMA, Bayer is following their declared principles on responsible clinical trial data sharing.
"Our commitment to clinical trial transparency reflects our will to foster scientific research and hence public health," said Dr. Joerg Moeller, member of the Bayer HealthCare executive committee and head of global development. "Joining the electronic platform and providing access to anonymized patient-level data, protocols and clinical study reports is a further step towards increased transparency while maintaining patient privacy."
Secured data access will be granted after approval of the research proposal by an independent scientific review panel. This applies to data on new medicines and indications that have been approved by the E.U. and U.S. regulatory agencies on or after Jan. 1.
In addition to the data provided via www.clinicalstudydatarequest.com, Bayer HealthCare provides information about Bayer HealthCare-sponsored trials dating back to 2005 through its “Bayer Trial Finder,” available at www.bayerpharma.com. This public information first becomes available at the beginning of a clinical study and is updated throughout the conduct of the study. Generally, summaries of trials will be published within a year of study completion.