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Supports efforts to increase the transparency of clinical trial data
May 14, 2014
By: Kristin Brooks
Bayer HealthCare will start sharing clinical data from its studies through the portal, www.clinicalstudydatarequest.com, where researchers can request anonymized patient-level data from Bayer HealthCare sponsored clinical studies listed on the site. By joining the portal, the company supports EMA efforts to increase the transparency of clinical trial data. Bayer is also a member company of the pharmaceutical trade associations EFPIA and PhRMA, also dedicated to responsible clinical trial data sharing. Following approval of a research proposal by an independent scientific review panel, secured data access will be granted. This applies to data on new medicines and indications that have been approved by the EU and U.S. regulatory agencies as of January 2014. According to the company, it will take all necessary measures to ensure that patient privacy is safeguarded, in accordance with applicable laws and regulations. “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.”
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