In an extraordinary move, the International Committee of Medical Journal Editors last week issued a proposal to require researchers to share their clinical trial data as a condition for publication. And the researchers would also have to submit plans for how their data can be shared. The journal editors, who represent such periodicals as The New England Journal of Medicine and the Annals of Internal Medicine, believe data sharing “will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society.” The move comes after protracted tussling over access due to safety scandals that revealed trial data for some products was never fully published or disclosed. We spoke with Harlan Krumholz, who runs the Yale Open Data Access project and works with companies to publish trial data, about the implications.
Pharmalot: Why does this matter?
Krumholz: People are conducting experiments all the time, and they are funded by various sources, but they are not sharing results. And by not sharing their data, they are biasing the medical literature. Someone goes to the literature and seeks to understand what they are researching, but they’re only seeing a fraction of the studies conducted. So the ability to gain a larger understanding is compromised. We and others have studied this problem and expressed concern, but it has persisted. Nothing was really changing.