IOM Touts Clinical Data Sharing; J&J Makes New Data Public
January 15, 2015 in News
The IOM report was funded by:
- The National Academy of Sciences;
- Several drugmakes, including AbbVie, Bayer, GlaxoSmithKline, Pfizer and Sanofi-Aventis; and
The first IOM recommendation calls for clinical trial data sharing to be the norm and expectation in part by requiring plans for data sharing as part of clinical trial protocols (Rice, Modern Healthcare, 1/14).
The second recommendation calls for the full, analyzable data set from a clinical trial to be published:
- Within 18 months of a study’s completion if a study is not meant to be part of a submission to a regulatory agency for product approval;
- Within 30 days of regulatory approval of a product; or
- Within 18 months after abandonment of a product’s development (Thomas, New York Times, 1/14).
IOM’s third and fourth recommendations call for:
- Stakeholders to implement strategies to promote data sharing, including creating technology platforms, increasing financial assistance and creating incentives; and
- Study sponsors to lead efforts to implement IOM’s recommendations (Rice, Modern Healthcare, 1/14).
Some stakeholders expressed support for the recommendations, while also cautioning that companies might not follow them because IOM does not have enforcement power (New York Times, 1/14).
Meanwhile, Jeffrey Drazen, IOM committee member and editor-in-chief of the New England Journal of Medicine, acknowledged in a perspective that “there are technical hurdles” to clinical data sharing but added that a shift in how companies think about such data is necessary. He said, “We need to view [clinical data] as a community resource, much like a shared park, rather than as personal property” (Rice, Modern Healthcare, 1/14).
Johnson Johnson To Publicize Certain Clinical Trial Data
In related news, Johnson Johnson on Wednesday announced that it will make all its clinical trial data on diagnostic tests and medical devices available to outside researchers through the Yale School of Medicine’s Open Data Access Project, Modern Healthcare reports (Lee, Modern Healthcare, 1/14).
The data release will make the company the first large devicemaker to systematically publicize such data, and the announcement comes after Johnson Johnson last year agreed to share clinical trial data with the project for its drug products.
According to Diana Zuckerman, president of the National Center for Health Research, the new agreement only applies to diagnostic tests and medical devices that have been approved since the start of 2014, excluding most products currently on the market.
In addition, Zuckerman noted that the data available on the products likely will be limited, as FDA allows some medical devices to be approved without undergoing clinical trials. She expressed disappointment at the limitations on what will be released, saying, “It will be fascinating to see what data are actually available” (New York Times, 1/14).