TransCelerate BioPharma Inc. Releases Recommended Approach for Protecting Personal Data in Clinical Study Reports
PHILADELPHIA -- TransCelerate BioPharma Inc. ("TransCelerate") today announced that it has developed a recommended approach for protecting personal data in Clinical Study Reports (CSRs) that are 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, and is available here.
The goal of the TransCelerate CSR Redaction approach is to provide organizations that share CSRs with a consistent way of protecting personal data that is contained in these documents. Information in CSRs will be removed or redacted in order 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, PhD, Chief Executive Officer 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.
About TransCelerate BioPharma Inc.TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies. The organization's 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. TransCelerate evolved from discussions at various forums for executive R&D leadership to debate current issues facing the industry and examine solutions for addressing agreed-upon common challenges. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Astellas Pharma Inc., Biogen Idec, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.), Medgenics, Inc., Shionogi & Co., Ltd. and UCB.
Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research and Development operations. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com/.
Chair – TransCelerate BioPharma Inc. Communications Committee
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