Big Pharma supergroup dishes on de-personalizing clinical data

TransCelerate BioPharma, a nonprofit founded by some of the world's biggest drugmakers, is looking to standardize how the industry protects patient privacy when sharing data.

In guidelines released last week, the group lays out how best to redact clinical study reports so that they may remain interpretable to researchers but do not imperil the privacy of the participants and investigators involved.

TransCelerate's goal is not to radically alter industry practice, and the guidelines fit with commonly held practices for disclosure. Instead, the group is looking to establish a consistent, replicable model for all drug developers, ideally making the process more efficient and predictable.

The recommendations come on the heels of last year's commitments from the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) to better share clinical trial results, and TransCelerate believes it has provided a road map for doing so safely.

"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," CEO Dalvir Gill said in a statement. "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 guidelines follow a rush of deals for the Philadelphia-headquartered nonprofit, which has partnered with Cognizant ($CTSH) to help standardize how sponsors and sites communicate, and teamed up with Medidata ($MDSO) to promote risk-based monitoring in clinical trials.

The group's membership includes AstraZeneca ($AZN), Boehringer Ingelheim, Bristol-Myers Squibb ($BMY), GlaxoSmithKline ($GSK), Johnson & Johnson ($JNJ) and Pfizer ($PFE), among others.

- check out the guidelines (PDF)
- here's TransCelerate's release