The NIH is the largest funder of clinical trials in the U.S., investing over $3 billion each year. Standards for scientific rigor and ethical oversight must be exceptionally high because the health and safety of human subjects are at stake. But challenges in the design, efficiency, and reporting of clinical trials are well documented–and may even threaten the progress of biomedicine.
In a recent JAMA article, Kathy Hudson, Ph.D., deputy director for Science, Outreach and Policy at NIH, Michael Lauer, M.D., deputy director for extramural research, and NIH Director Francis Collins describe several new initiatives for improving clinical trials. Their aim is to catalyze more innovative and robust trial design and accelerated access to discoveries. Several new policies are being rolled out to this end.
1. The Department of Health and Human Services issued a new regulation and the National Institutes of Health rolled out a new policy to increase availability of information about clinical trials. The DHHS regulation, known as The Final Rule, implements existing FDA requirements to register and report clinical trials on ClinicalTrials.gov. The NIH policy complements The Final Rule and applies to all clinical trials funded by NIH, regardless of whether they are subject to the regulation. Both the NIH policy and the Final Rule will take effect Jan. 18, 2017. Here are some resources to help you better understand the changes:
- A summary of the Final Rule and NIH policy
- A table comparing and contrasting the Final Rule and NIH policy
- A summary table of changes to clinical trial registration and results information data elements resulting from the Final Rule
- Information regarding clinicaltrials.gov registration
2. A new NIH policy requires all applications involving clinical trials be submitted through a Funding Opportunity Announcement specifically designed for clinical trials. NIH will no longer accept applications through parent FOAs or other announcements not specific to clinical trials. The aim is to ensure that key trial protocol information will be included in a standard way across clinical trial applications. The target effective date for this policy is Sept. 27, 2017.
3. A policy issued in June, 2016 requires use of a single institutional review board for multi-site studies in order to streamline and expedite IRB review. The first applications that will incorporate the new requirements will be for those with due dates of May 25, 2017. Resources are still under development – stay tuned for more information and guidance.
4. A policy that goes into effect Jan. 1, 2017 requires all NIH-funded investigators and clinical trial staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials to be trained in Good Clinical Practice. GCP training includes the Principles of the International Conference on Harmonisation and can be achieved through a class, academic training program, or certification from a recognized clinical research professional organization. The good news for OHSU investigators is that OHSU’s Responsible Conduct of Research training through the CITI program qualifies under this new policy.
5. A clinical trial protocol template is being developed with input from the research community. An updated template should be released this fall to be used as a way to organize and standardize key details that should be included in clinical trial protocols.