With pharma trade groups now committed to publishing the synopses of clinical study reports (CSRs) for some drugs, big-name consortium TransCelerate BioPharma has published a guide on how to redact documents.
The guide covers the technical aspects of CSR redactions, such as the need to remove personal details included in metadata. TransCelerate also recommends the use of professional redaction software, a measure that eliminates the risk someone could reveal data hidden by a black box by copying and pasting the text. The U.S. military is among the organizations to inadvertently leak classified details by failing to properly redact a document.
Such technical considerations make up a relatively small part of the guide, which is mainly focused on explaining what information should be removed, redacted and retained. The stated goal of the guide is to protect the privacy of patients and people involved with running the trial. As such, TransCelerate recommends targeting information linked to individuals, for example by removing lists of their data and redacting details of specific medical outcomes, such as a rare disease or congenital abnormality.
The debate over what information should be shared and how is far from over--the European Medicines Agency is holding meetings to discuss the portal over the next couple of months--but TransCelerate thinks the guide moves things forward. "Sharing of CSRs] must be done in ways that protect the privacy of those involved, and the adoption of a consistent approach is an important step forward," GlaxoSmithKline's ($GSK) head of medical policy, Andrew Freeman, said in a statement.
- read the release
- here's the guide (PDF)