Bayer HealthCare to Share Clinical Study Data Online
Bayer HealthCare has joined ClinicalStudyDataRequest.com and will share data from its clinical studies through the internet portal, the company said. Qualified researchers are able to request anonymous patient-level data from clinical studies listed on the website.
The move is a sign of support of the European Medicines Agency’s desire to increase data transparency for clinical trials. Bayer says it also is following the philosophy of responsible clinical trial data sharing set forth by the pharma trade associations EFPIA and PhRMA — both of which Bayer is a member.
“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,” said Joerg Moeller, Bayer HealthCare executive committee member and head of global development.
Secured data access will be granted after a research proposal gains approval from an independent scientific review panel. Bayer will have no involvement in the process, which reviews the proposed science, publication plans, research team qualifications and conflicts of interest. This applies to data on new medicines approved by the EU and U.S. on or after Jan. 1, 2014.
Bayer HealthCare said it also will provide information about its sponsored trials dating back to 2005 on its own “Bayer Trial Finder,” available at Bayerpharma.com. Public information will initially become available at the beginning of a study and will be updated throughout. Trial summaries will be published within a year of study completion. — Kellen Owings