During our May CTSA Program Webinar we presented specific language regarding limitations around the types of clinical trials (CTs) that NCATS is allowed to fund. The current Public Health Service (PHS) Act states: “The Center may develop and provide infrastructure and resources for all phases of clinical trials research. Except as provided in paragraph (2), the Center may support clinical trials only through the end of phase IIB.”
The referenced exception relates to therapies that are being developed for a rare disease or condition, for which NCATS is allowed to fund Phase III CTs provided certain conditions are met prior to award, including: 1) giving more than 120 day public notice of NCATS’ intent to fund the Phase III CT for a rare disease or condition; 2) no public or private organization provides a written credible intent to NCATS that the organization has timely plans to conduct Phase III CTs of a similar nature; and, 3) the development of the therapy does not increase the government’s liability beyond the award value.
Which Phase III Definition? So here is where definitions matter. The PHS Act does not define what qualifies as a Phase III clinical trial. To align with the intent of the PHS Act, the NCATS Policy uses the 21 CFR definition of a Phase III CT. This means that the clinical trial must be in support of the clinical development of an FDA-regulated product. The 21 CFR definition is what NCATS uses to decide whether or not we are allowed to fund certain CTs.
In addition to our 2018 Notice to the Guide (NOT-TR-18-025), moving forward we will include the policy language in all future NCATS’ funding opportunities & Notices of Award. We are developing additional processes for early identification of potential 21 CFR-defined Phase III CTs to ensure that we comply with our PHS mandate. In addition, institutions and principal investigators are encouraged to discuss with their NCATS Program Officer any potential 21 CFR-defined Phase III CTs to be proposed and/or changes to planned Phase II CTs.
We hope this provides additional clarification on NCATS’ policy regarding clinical trial support and the definitions we are using.
For any questions, please contact your Program Officer.