Roche launches new process for access to data from clinical trials
Roche will work with an independent body of recognized experts to evaluate and approve requests to view anonymous data of patients. The company will support the release of full clinical study reports for its licensed medicines by regulatory authorities and make other CSRs available for research requests.
"We understand and support calls for our industry to be more transparent about clinical trial data with the aim of meeting the best interests of patients and medicine," Daniel O'Day, the COO of Roche Pharma, said. "At the same time, we firmly believe that health authorities need to remain the gatekeeper for drug assessment and approval. We believe we have found a way in which patient data can be provided to third party researchers in a legitimate environment that ensures patient confidentiality and avoids the risk of publishing misleading results or giving rise to public health scares and consequences."
Changes to Roche data transparency policies include increased access to patient data sets, access to CSRs and access to data on Tamiflu.
Roche supports the European Medical Agency in its efforts to proactively publish data from all clinical trials that support the authorization of medicine. Roche is a member of an EMA advisory group that is working on the new guidelines for EMA data access. The policy is anticipated to come into force in early 2014.