Mike's Blog

"An economist is an expert who will know tomorrow why the things he predicted yesterday didn't happen today. "

- Evan Esar

While we may be in the final quarter of FY23, for grants management, this is crunch time, analogous to tax accountants in April. As such, while many grant awards and actions are in progress, we are pleased to provide an interim update for the CTSA community on the status of the first tranche of hub awards (totaling 10), using the new UM1 mechanism, as well as to demonstrate alignment with the FY23 Congressional Report language that “no hub shall receive less than 95% of the resources that were provided prior to fiscal year 2022”. Due to the sharp pencils (and brains) of NCATS’ resident bean counters, our budget modeling and forecasting has enabled us to meet, and even exceed, not only this Congressional directive, but also our expectations. With our new suite of CTSA opportunities a hub is defined by an active 7-year UM1 award, so we compared directly the UL1 award figures from the previous year of the new UM1 award figures of the new year. FY23 interim public data from NIH RePORTER shows that overall, of the first 10 CTSA UM1s awarded, the average increase per CTSA UM1 award over that of the prior year UL1 GY5 (FY22) is 12 percent (range 0% - 54%). 

We have included two figures that present the data as derived from NIH RePORTER. These data can be recapitulated via a search through NIH RePORTER with the terms UM1 under NCATS (search here) and using the public CTSA data from NIH RePORTER for FY14-FY22 on our website (https://ncats.nih.gov/ctsa/funding) aggregated here: CTSA Program Funded Activities and Other Sources.

First, a few highlights of the new suite opportunities. The UM1 hub award has been increased from 5 to 7 years, providing stable funding for a longer period of time. The separation of the hub UM1 from the career development and other optional awards reduced the risk of the career development or other optional awards to negatively affect the review of the core hub. We have experienced situations where a less meritorious K or T would reduce the overall score and jeopardize an award for a well-scoring U54 hub application, sometimes leading to hubs choosing to jettison the T program upon U54 resubmission. Separation has also allowed for more focused application reviews of higher quality. And finally, the administrative separation of the mechanisms has permitted different budget start dates from that of the UM1, allowing the CTSAs to implement K and T programs in harmony with local needs and aligning the awards with the academic calendar.

FY23 interim public data from NIH RePORTER shows that the first 10 CTSA UM1s also have meritorious K12 career development awards. While initially, there must be a concurrent submission of both a UM1 application and a K12 application, the K12 may be resubmitted at any time the submitted UM1 application or award remains active (NOT-TR-22-022). We do anticipate and expect that every UM1 will have a K12 during the 7-year UM1 award period. NIH RePORTER data shows that for the first 10 K12s awarded, the average increase per CTSA K12 over that of the KL2 GY5 (FY22) is 20% (range -6% to 40%). What NIH RePORTER will not unfortunately show for Ks is the number of scholars supported. The FY23 applications had a potential increase of 8% in scholars if all applications were meritorious, and of the first 10 K12 awarded, the average increase per K12 over that of the KL2 GY5 (FY22) is 15% (slots from -1 to +3).

This new suite has also reduced the risk of submitting optional T components. This will allow for growth of predoctoral, postdoctoral and short-term training programs. In FY22, only 50 out of 63 CTSAs provided support to the translational science research workforce. With the new suite, we are able to provide enhanced opportunities and additional flexibilities to the hubs to invest and grow their workforce. With applications received in the first year alone there has been a potential increase in the number of predoctoral trainees by 57% and postdoctoral trainees by 67% if all applications were to be meritorious.

Potentially, over the next several years, once all CTSAs have transitioned to become UM1 hubs predoctoral trainees could increase by 39% (over current levels) and postdoctoral trainees could increase by 23%. Institutions may submit these applications any time during the 7 year period of the active hub award (NOT-TR-22-008).

In addition, a recent analysis of the CTSA TL1 portfolio, assessing CTSA Program support for physician-scientists, showed that over the last 10 years ~50 dual-degree postdoctoral trainees have been supported per year by the CTSA Program (~35% of the total CTSA supported postdocs) and ~78 dual degree K scholars are supported per year (~20% of the total CTSA supported K scholars). In summary, this new suite has the flexibility and potential to significantly increase the number of clinical and translationally trained young investigators—something we were hoping to see play out!

Previously, short-term research programs have been underutilized in TL1s (in FY22 only 4 hubs had short-term programs). Hubs are taking advantage of the new R25 opportunity to build the translational science workforce at an earlier stage and in areas of need. So far, we have 3 awarded R25s focused on different approaches to enhancing the diversity of the early biomedical workforce pipeline (link to awards here).

We have also expanded opportunities to support cutting-edge translational science research. In addition to stabilizing and extending the UM1 hub award and increasing the translational science research workforce, the CTSA also has the opportunity to apply for up to 2 awards for high impact specialized innovation programs of $500,000 per year for 5 years. These awards are designed to address critical gap areas or emerging technology innovations in clinical and translational science. An additional effort under the UM1 award is also designed to support at least one translational science research project of no less than $125,000 per year. A few of the UM1 Translational Science Research Projects proposed by the new awardees and a few of our new RC2 awardees will be discussed at the 2023 Fall CTSA Program Annual Meeting, November 6-8 (registration now open here).

Lastly, NCATS’ September Council (9/21/23) will include the annual ‘state of the CTSA program’ presentation, where we plan to share what we anticipate to be the full FY23 award slate.

Nothing in life is to be feared, it is only to be understood.

Now is the time to understand more, so that we may fear less.

- Marie Curie