Industry group TransCelerate Biopharma has developed a new recommended approach for protecting patients’ personal data in Clinical Study Reports (CSRs) shared with researchers, patients and others as part of plans to release more data under consideration in the EU and US.
The goal of the TransCelerate CSR Redaction approach is to provide research organizations that share CSRs with a consistent way of protecting personal data.
All personal patient information and investigator names will be removed or redacted, while tables or figures containing summary information, as well as references to the sponsor, including vendors or CROs which take responsibility for conducting nonclinical or clinical studies will be kept. Country location for investigator, non-sponsor vendor/co-development partner companies, IRB/ECs, and IDMCs (independent data monitoring committees)/SDACs (statistical and data analysis centers) will also be retained.
The approach offers practical details to help implement the July 2013 commitment made by members of the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The release also comes soon after the EMA (European Medicines Agency) decided to delay its formal adoption of a policy on publishing trial information.
"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.
According to TransCelerate, members will consider applying the following:
• The standard approach seeks to protect privacy regardless of the audience;
• The extent to which the content of a CSR is disclosed is at the discretion of an individual company and may differ for current and legacy CSRs;
• Case-by-case assessments may be required by individual companies to determine the appropriateness of disclosing a particular CSR in special circumstances (e.g., rare diseases, small populations), where any disclosure may jeopardize privacy. Additionally, for individual patient cases where normal redaction approaches would have a higher risk of re-identification, these would also require case-by-case assessment (e.g. survival data in a small subset of patients, a single subject with complete response); and
• Aggregated data or descriptions of aggregated data and study level information (e.g. public register IDs, tabular, graphic, or cross-patient data) will rarely raise privacy concerns and can be retained. An exception might be aggregate categories with a single subject and a reasonable likelihood of being re-identified.
"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, 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."