Roche is expanding access to its clinical trial data for third party researchers. Roche will work with an independent body of recognised experts to evaluate and approve requests to access anonymised 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.
Amendments to the Roche data transparency policy include:
Access to patient data sets: An independent body will assess the scientific validity of requests for anonymised patient-level data, with the requested data made available within a secure system following agreement. Access to patient data will be available for those clinical trials which have been submitted together with an application for a medicine’s registration and will be available after the completion of regulatory reviews in the U.S. and European Union. This process will come into effect in 2013. Roche is in discussions with other pharmaceutical companies to see if this can be an industry-wide initiative.
Access to CSRs: Roche supports the release of full CSRs, summaries and safety updates for its approved medicines by the EMA. In line with relevant country or regional laws, this information will be edited in consultation with Roche to ensure patient confidentiality and to protect legitimate commercial interests, including intellectual property rights. Roche will provide any CSR on request that cannot be obtained from the EMA for third party researchers with this specific process coming into effect by April 2013. This will enable access to all Roche CSRs for researchers.
Tamiflu (oseltamivir) data
Roche acknowledges the specific public interest in data transparency concerning the antiviral Tamiflu. Health authorities worldwide have received all the information they have requested regarding Tamiflu.
Of 74 completed Roche sponsored Tamiflu trials, 71 (or 96%) are in the public domain either as a primary publication or secondary publication or on rochetrials.com. Arrangements are underway for the three sponsored trials which are completed but not yet in the public domain to be posted.
Roche supports a fair, transparent and independent way of addressing data transparency regarding Tamiflu. To do this, a MUlti-party Group for Advice on Science (MUGAS) will be set up by four renowned scientists in the field of influenza to look at data on Tamiflu, identify any unanswered questions and agree on a statistical analysis plan. Following an agreement, Roche will provide access to all requested Tamiflu clinical trial data for the analyses.
The four scientists will invite independent experts and third parties to their meeting, which is scheduled to take place in June. The four scientists are Prof Albert Osterhaus, Erasmus Medical Centre Rotterdam; Prof Menno De Jong, Academic Medical Centre Amsterdam; Prof Arnold Monto, University of Michigan and Prof Richard Whitley, University of Alabama.