The National Center for Advancing Translational Sciences (NCATS) Advisory Council approved program modifications to the Clinical and Translational Science Award (CTSA) program during its virtual meeting on June 11. The changes were informed by input received through the request for information (RFI) NCATS issued in 2019, to which the AAMC responded, and by other stakeholder feedback [refer to Washington Highlights, Nov. 1, 2019].
These program changes were designed to address three key themes identified from stakeholder input: decreasing applicant administrative burden, increasing hub flexibilities and specialization opportunities, and expanding hub funding options.
The Advisory Council unanimously approved five CTSA concepts for new awards: Clinical and Translational Science Award (UM1); Specialized Innovation Programs (SIPs) (RC2); National Research Service Award (NRSA) Institutional Predoctoral and Postdoctoral Research Training Grants (T32); Institutional Career Development Award (K12); and Research Education Grant (R25).
The approved concepts will make the CTSA hub award (UM1) independent of the other components of the award. The CTSA application will no longer be combined and scored as a package. Instead, the hub, career, and training awards will be reviewed and scored separately. Additionally, the funding mechanism for the hub award will shift from a U54 to a UM1, and the award period will increase from five to seven years.
The awards will now be calculated using a rolling average of the applicant’s previous five-year total NIH funding plus the rolling average of the partners’ previous five-year NIH clinical research funding. Despite this change, NCATS anticipates the total number of CTSA awards will not decrease and the award size will be comparable to what each hub receives currently. Each institution will be limited to one hub (U) award, one career development (K) award, and one of each of the three types of training (T/R25) awards.
The enhancements indicate that the CTSA program partnerships remain a priority. The program enhancements are aimed to further emphasize clinical research capabilities and the inclusion of collaborators to address the burden of conditions that disproportionately affect minority and other underserved populations.