TransCelerate BioPharma has developed a recommended approach for protecting personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others.
The document describes an approach to apply when redacting or removing personal information from CSRs and other related clinical trial documents.
The goal of the TransCelerate CSR Redaction approach is to provide organizations that share CSRs with a consistent way to protect personal data contained in these documents. Information in CSRs is removed or redacted to protect the privacy of patients and those associated with a clinical trial.
"Through the implementation of this approach and additional forthcoming work from this team, TransCelerate will aid in simplifying and operationalizing enhanced transparency, while safeguarding the privacy of individuals involved in clinical trials," said Dalvir Gill, Ph.D., CEO of TransCelerate. "By developing and providing a consistent approach, TransCelerate continues to drive efficiencies that will help ensure industry resources are focused on improving the health of people around the world."
The approach provides practical details to help implement the July 2013 commitment by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies titled Principles for Responsible Clinical Trial Data Sharing.
"Increasing transparency of clinical trial information by making clinical study reports more widely available is a goal we all share. This must be done in ways that protect the privacy of those involved, and the adoption of a consistent approach is an important step forward," said Andrew Freeman, director and head of medical policy at GlaxoSmithKline, and TransCelerate clinical data transparency initiative co-lead.
TransCelerate expects its recommended approach will be adopted widely by sponsors as the industry sees a greater demand for clinical data transparency.
TransCelerate is a nonprofit dedicated to improving the health of people around the world by accelerating and simplifying the R&D of innovative new therapies. Its mission is to collaborate across the global R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of medicines. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group and Sanofi. Since its inception these companies have joined: Allergan, Astellas Pharma, Biogen Idec, Cubist Pharmaceuticals, EMD Serono (a subsidiary of Merck), Forest Research Institute (a subsidiary of Forest Laboratories), Medgenics, Shionogi and UCB.
Membership in TransCelerate is open to pharma and biotech companies with R&D operations. Executive offices are located in Philadelphia.