Today we took a huge step forward in our efforts to make sure that data from biomedical research is shared widely and rapidly. The NIH, in collaboration with our fine colleagues at the U.S. Food and Drug Administration (FDA), and with the valuable input from scientists, patients and other members of the public, has announced the HHS regulation and NIH policy to ensure that information about clinical trials is widely shared. In this blog I want to talk about what this will mean for patients, providers, and researchers. I also want to reflect a bit on how the new regulation and policy fit into our overall efforts to improve clinical trials and data sharing.
Clinical trials are essential for the translation of research advances to new approaches to prevention and treatment. Volunteers who take part in clinical trials often do so with no assurance of personal benefit, but with the expectation that their involvement will add to the growing body of knowledge about health and disease, and thus may help others someday. For that to be realized, all trial results information needs to be publicly reported in a timely fashion—and yet we know that doesn’t always happen. Today’s announcements aim to change that. The HHS regulation issued today, called a “final rule”, describes requirements for registering certain clinical trials and submitting summary results information from these trials to ClinicalTrials.gov, a database managed by NIH’s National Library of Medicine (NLM).
The rule implements the statutory requirements established by Congress for ClinicalTrials.gov to serve as a public source for information about clinical trials.