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. The regulation applies to most interventional studies of drug, biological, and device products that are regulated by the FDA. The requirements do not apply to phase 1 trials of drug and biological products, or small feasibility studies of device products. To help clinical researchers and research institutions understand their obligation under the regulation, NIH and FDA will be undertaking extensive outreach and education efforts over the coming weeks.
Because of our commitment to data sharing, especially for studies supported with public funds, NIH has issued a complementary policy today that applies to all NIH-funded trials, including those not subject to the regulation. That will also include clinical trials of behavioral interventions that don’t involve an FDA-regulated product. We will be taking the implementation of the regulation and of the NIH policy very seriously and have put in place robust enforcement and compliance measures.
While data sharing is the right thing to do, it is not always easy. I learned this firsthand, when as part of a test of the new system some time ago, my senior team and I tried to enter sample data from a trial into ClinicalTrials.gov—it is not a trivial task. Registering a trial and submitting results information should not cause researchers to pull their hair out, nor should it take an inordinate amount of time away from valuable research. That is why we will be doing all we can to make submitting information to ClinicalTrials.gov as frictionless as possible for the regulated community. To this end, NIH’s NLM, which operates and manages ClinicalTrials.gov, will be working hard over the coming weeks and months to improve the data entry portal for ClinicalTrials.gov, so that the process for submitting information to ClincialTrials.gov is significantly improved before the rule and NIH policy become effective early next year.
ClinicalTrials.gov contains a treasure trove of information, and the value of this information will continue to grow as more studies are added when investigators and institutions follow the new rules. We need to make this information easily accessible to patients and those who love and care for them. If your daughter, sister, or father is sick and out of options, it should be simple and intuitive to search for clinical trials that may be relevant. I am delighted to announce today that NLM will work with IT experts from the 18F group to help make ClincalTrials.gov a more user-friendly resource for finding information about clinical trials of interest to patients, family members, healthcare providers, and researchers. This partnership will build on lessons learned from the National Cancer Institute’s collaboration with technical experts and Presidential Innovation Fellows to enhance access to information about cancer clinical trials at Cancer.gov as part of the Cancer Moonshot.
We have been encouraged in our efforts to make sure patients have the information they need by Vice President Biden, who has demonstrated an extraordinary interest and commitment to research and data sharing through the Cancer Moonshot. He is passionate about ensuring that patients and those who care for them have straightforward access to comprehensive and reliable information about clinical trials. And he has vigorously made the case that science can only contribute to progress if results information from clinical trials is shared rapidly and widely.
Rapid, broad sharing of research information is a core value of NIH and one that has been embraced and advanced by this Administration. Data sharing is also very close to my heart and has been a key priority throughout my career. In the early days of the Human Genome Project, we established data sharing policies for depositing genetic data into public databases within 24 hours. Today, we have set forth remarkable initiatives for sharing summary level clinical trials information. But we still have a long way to go. Sharing individual patient level data from trials is still on the list. The NIH has evaluated various models for making the sharing of these data feasible and useful to researchers. We are also exploring ways to support large scale sharing of research data and other information through the development of a cloud-based data commons. The NIH is committed to doing our part in sharing research data, and I hope you will join us in this effort.
“HHS takes steps to provide more information about clinical trials to the public,” NIH News Release, September 16, 2016.
“Summary of HHS/NIH proposals to enhance transparency of clinical trial results,” NIH News Release, September 16, 2016.
Sharing and Reporting the Results of Clinical Trials. Hudson KL, Collins FS. JAMA. 2016 Sep 16. 313(4)
Trial Reporting in ClinicalTrials.gov—The Final Rule. Zarin, M.D., Tse T, Rebecca J. Williams RJ, Carr S. NEJM. 2016 Sep 16. [Epub ahead of publication]