Roche Launches New Process for Accessing Clinical Trial Data
Roche today announced that it is expanding access to its clinical trial data for third party researchers. Roche will work with an independent body of recognized experts to evaluate and approve requests to access anonymized patient-level data. Roche will support the release of full clinical study reports (CSRs) for all its licensed medicines via regulatory authorities and make available any CSRs that cannot be provided by these authorities upon a researcher’s request.
“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,” said Daniel O’Day, Chief Operating Officer of Roche Pharma. “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.”
Roche continues to provide all information requested by health authorities who approve medicines for patient use. Public access to results from clinical trials is also provided via rochetrials.com and clinicaltrials.gov in a summary form. Roche will also submit results to the European Union database, EudraCT as soon as this public archive becomes operational.
Roche is supporting the European Medicines Agency (EMA) in its commitment to the proactive publication of data from all clinical trials supporting the authorisation of medicines. Roche is a member of one of the EMA advisory groups working on the new EMA data access guidelines. The policy is scheduled to come into force early 2014.