BioCentury
ARTICLE | Politics & Policy

IOM to provide guideline on data transparency

April 5, 2013 11:07 PM UTC

The Institute of Medicine said it plans to conduct a study later this year for strategies on how to responsibly share clinical trial data. The institute will seek input from a group of stakeholders -- including industry, patient groups, academic institutions and government and regulatory agencies -- to develop guidelines for data sharing to address concerns related to patient privacy, confidential information and scientific integrity. IOM noted that "data holders are beginning to individually generate policies for clinical trial data access," and said "better alignment among stakeholder actions" is needed. The institute said it will hold a planning meeting for potential sponsors and stakeholders in the near future.

Novartis AG (NYSE:NVS; SIX:NOVN) said an industry group that includes at least 12 biotechs and pharmas from the U.S., Europe and Japan will work with IOM to develop a statement of task. The pharma said the industry group "will seek to gain broad adoption of a unified approach" for data sharing across industry, academia, government and private foundations. ...