Abstract
Roche Pharmaceuticals announced that it will release clinical study reports for licensed drugs, joining a trend toward making data available for future meta-analyses to accelerate progress in cancer research.
In late February, Roche Pharmaceuticals added its name to the list of institutions moving toward increased transparency for clinical trial data, a few weeks after a similar announcement by GlaxoSmithKline (GSK).
Roche will release clinical study reports for licensed drugs via regulatory authorities or via request if the authorities can't provide the data, while GSK will make available such reports for all approved and discontinued medications. These steps are in line with an initiative by the European Medicines Agency (EMA), which began proactively publishing clinical study reports in December 2012.
“It's the right thing to do,” says Perry Nisen, MD, PhD, senior vice president of science and innovation at GSK in Philadelphia, PA. “Meta-analysis of primary patient-level data from multiple sources will help enable researchers to predict cancer progression, determine how to intervene, and discover how to categorize and differentiate cancers based on natural histories and results.”
“As we sub-segment down to narrower and narrower populations based on biomarker data, we're going to need larger-scale data available in order to study those populations,” agrees Amy Abernethy, MD, director of the Duke Center for Learning Health Care at Duke University in Durham, NC.
The next step is to figure out how to share the patient-level data and with whom to share it. “How do we identify the common data standards and what the rules are?” asks Nisen. “There's no precedent for that.” He supports the idea of an “independent data custodian” to ensure patient data integrity, preserve anonymity, and safeguard against non-scientific approaches to data analysis.
“Some companies are saying, okay, transparency is important, but now they need to grapple with what that really means,” comments Abernethy, an academic collaborator on Project Data Sphere, a neutral platform for aggregating and sharing clinical trial data that was launched last year.
By the end of 2013, Roche will set up an independent body of experts to approve requests for patient data. “Provision and analysis of patient data should be conducted in a legitimate and independent environment to avoid the risk of publishing misleading results or giving rise to public health scares,” says Michael Doherty, MS, Roche's global head of regulatory affairs in San Francisco, CA. “We strongly believe that health authorities need to remain the gatekeeper for drug assessment and approval.”
However, not everyone is jumping on the transparency bandwagon. In early March, AbbVie took legal action to block the EMA from releasing data on the drug Humira, used to treat rheumatoid arthritis and several other conditions, to protect the company's competitive edge.
