Mike's Blog

This second year of the new CTSA suite of awards we welcome two new CTSAs, Dartmouth-Hitchcock Clinic and Baylor College of Medicine, to the consortium in addition to 9 UM1 CTSAs that transitioned from UL1s. Those 9 UM1 CTSAs that were awarded during FY24 have an average total cost increase of 12% in aggregate over their UL1 Grant Year 5 budgets (excluding supplements, offsets, carryovers, adjustments to final award amounts that may be made due to unallowable costs, errors in the application, and/or issues of overlap on personnel effort). Again, as directed by the FY24 Congressional Report language, all prior CTSA Hub award recipients received at least up to 95% of the prior CTSA award funding level if requested, in accordance with the bona fide need rule (US Code Title 31, Section 1502 (a)). Though the FY24 budget remained flat we were able to retain 63 hubs, similar to FY22 and FY23, noting that last year, 16 new UM1s were awarded compared to the 11 for FY24.  We are hearing rumblings of another flat budget that is bound to make FY25 challenging.

We continue to develop the next generation of the translational science workforce through the support of 11 new K12 programs in FY24. Of the programs with previous KL2 programs, 80% either had no changes in the number of scholars they were supporting or an increase in the number of scholars and the 10 transitioning programs (not including one institution never-before funded) had an average increase of 16% overall in scholar slots. This represents an increase over FY23 where the average increase was 14% overall in scholar slots in 12 new K12s.

We recognize the perceived growing pains within the T32 predoctoral and postdoctoral programs; however, the data show a positive growth overall with 15 new programs. Our ultimate goal is to expand and grow this portfolio across the consortium and with the de-coupling of the T from U we are seeing hubs submit training program applications that had not submitted in prior application rounds or are submitting new training programs – and being successful!  Over the last two FYs of the 27 of the UM1 awardees, 17 applied for a postdoctoral T32 with 14 awarded, 16 applied for a predoctoral T32 and 13 were awarded.  Of the 27 UM1 awardees (over two years), 4 have expanded into supporting trainees they were not supporting prior and 2 have brand new T programs!   

The CTSA Research Education Program (R25), supporting educational activities and research experiences for participants to get exposure to clinical and translational science added two new programs to the mix this year. One program will target increasing diversity with training focused on eliminating health disparities and improving health care quality while the other will immerse medical and pharmacy students in research experiences. We look forward to future R25 program that creatively address filling the workforce pipeline.

The High Impact Specialized Innovation Program portfolio is taking more time to grow with one award released late this FY from PI Dr. Alexander Krist at Virginia Commonwealth University (Virginia Accountable Health Equity and Action Dashboard (VA-AHEAD): Community Framing of Equity Data to Support Clinical and Translational Science). This RC2 proposes to address the translational science roadblock to address health equity by working with local communities and accessing local data to set priorities to understand the underlying causes of inequity, developing interventions and tracking progress. Demonstrating that these RC2s are indeed high impact, Dr. Saif Khairat from UNC, (that you heard about his RC2 from last year during the NCATS Session at the Fall CTSA Program meeting), was invited to the White House in June to discuss evidence from his project supporting the permanency of telehealth post-public health emergency, with a focus on improving clinical outcomes for all, especially with highly vulnerable populations. The Center for Virtual Care Value and Equity (ViVE) team and others presented scientific insights and evidence supporting the need for policies that promote and expand telehealth.

In summary, in FY24 the new CTSA Suite funded 11 UM1s, 11 K12s, 15 T32s, 2 R25s and 1 RC2. From these first two years of listening to the community, hearing the reviews, talking with reviewers, and processing awards, we learned a lot and incorporated efficiencies into the new UM1 that was released this September 4, 2024 (PAR-24-272). There is some minor tweaking of language that addresses the various creative interpretations we have found from both applicants as well as reviewers. Also, Element E page length has been increased. The release itself was unfortunately delayed due to NIH’s recent efforts to optimize language focused on diversity to ensure full compliance with current statutes and case law. Some PIs that are applying this year may find this delay advantageous, if they do the calculation (organizations become eligible when there are 16 months remaining on the project date at time of the receipt date for the new NOFO), as the first receipt date is March 13, 2025, and it would appear that organizations may be able to apply to the March AND (if unsuccessful) the September receipt dates for consideration for funding in FY26. Applicants will still have 6 months to prepare their UM1 application without any impact on subsequent award dates. The other NOFOs, K12, T32, and R25, do not require the 6 months lead time to prepare an application, however, these are also awaiting new NOFO templates from NIH that will incorporate the new National Research Service Award (NRSA) revised application form, training table instructions, and modified review criteria (NOT-OD-24-129). As the eligibility of the CTSA suite of NOFOs are connected to the UM1, the intention is to release these with the receipt date being the same as the UM1, of March 13, 2025.

And if administrative minutia and numbers are not your forte, you may have missed the ‘State of the CTSA Program’ presentation at NCATS Council last month that provided an overview of some of the exciting science happening within the CTSA Program over the last year. Highly recommended for anyone with a sleep disorder. One interesting topic of discussion during Council was a letter from current and former Council members recommending that NCATS should be converted from a ‘Center’ to an ‘Institute’ (letter: here).

Finally, we look forward to seeing many of you in person at the 2024 Fall CTSA Program Annual Meeting, November 14-15 (registration now open here through November 1)!  A couple of highlights from NIH will be that Dr. Bertagnolli, the NIH Director will be presenting the keynote, Dr. Janine Clayton, the Director of the NIH Office of Research on Women’s Health, will speak about the Women’s Health Initiative, and the NCATS Session will highlight funded UM1 Element E projects, RC2s and (new this year) R03s!   

As we pen this blog, there is still some uncertainty regarding the FY25 budget. Hopefully, we’ll be able to read what we wrote. At this time, a true legend with insight comes to mind.

If I studied all my life, I couldn't think up half the number of funny things passed in one session of congress. 

The budget is like a mythical bean bag. Congress votes mythical beans into it, then reaches in and tries to pull real ones out.

The only difference between death and taxes is that death doesn't get worse every time Congress meets.

This country has come to feel the same when Congress is in session as when the baby gets hold of a hammer.

- Will Rogers