Bayer HealthCare announced that it will start sharing data from its clinical studies through the internet portal www.clinicalstudydatarequest.com. From now on, qualified researchers can request anonymised patient-level data from Bayer HealthCare sponsored clinical studies listed on the website.
By joining the portal, Bayer HealthCare is supporting efforts of the European Medicines Agency (EMA) to increase the transparency of data from clinical studies. As a member company of the 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 EU and US regulatory agencies on or after January 1, 2014. Bayer HealthCare is not involved in the decisions made by the independent scientific review panel. Bayer HealthCare will take all necessary measures to ensure that patient privacy is safeguarded, in accordance with applicable laws and regulations.
In addition to the data provided via www.clinicalstudydatarequest.com, Bayer HealthCare provides through its ‘Bayer Trial Finder’ available at www.bayerpharma.com information about Bayer HealthCare sponsored trials dating back to 2005. 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.
The joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing are available at:
www.efpia.eu/mediaroom/132/43/Joint-EFPIA-PhRMA-Principles-for-Responsible-Clinical-Trial-Data-Sharing-Become-Effective-Today.