Bayer and Boehringer Ingelheim pledged to provide increased access to clinical trial data to the scientific community, following recent similar initiatives from companies including Novartis, Johnson & Johnson, GlaxoSmithKline, Pfizer, Sanofi and Roche.
Under its initiative, Bayer said it will grant access to anonymised patient-level data from company-sponsored clinical studies to qualified researchers for products that have been approved by US or European regulators on or after January 1 this year. Bayer noted that it will provide access through an internet portal in support of the European Medicine Agency's efforts to increase the transparency of data from clinical studies and in line with pledges by the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America to increase data sharing.
Under Bayer's programme, secured data access will be granted after a research proposal is approved by an independent scientific panel. The company said that it will have no involvement in the decisions of the panel. "Our commitment to clinical trial transparency reflects our will to foster scientific research and hence public health," remarked Joerg Moeller, head of global development at Bayer HealthCare.
Meanwhile, Boehringer Ingelheim indicated that it will make available clinical study data and other clinical study related documents for approved products or after termination of a drug development programme for studies dating back to 1998. The company noted that clinical study reports and other documents will be requested through its dedicated website, with access granted after approval of a study protocol by an independent external review panel. The drugmaker stated that these commitments were announced last year, and are now being implemented with the creation of a website and formation of a dedicated team to respond to requests.
In addition, Boehringer Ingelheim confirmed its commitment to publish results from all sponsored studies in peer reviewed journals and at scientific meetings, regardless of outcome for all types of clinical trials. "The free exchange of scientific information is the basis for innovation in medicine," remarked Christopher Corsico, global head of clinical development, medicine and regulatory at Boehringer Ingelheim, adding "going beyond applicable regulatory and legal requirements, we...feel it is the right approach and hope it will benefit science."
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