According to the CTSA Consortium Website, this program seeks to transform “how clinical and translational research is conducted, ultimately enabling researchers to provide new treatments more efficiently and quickly to patients” and specifically to:
- Encourage the development of new methods and approaches to clinical and translational research
- Improve training and mentoring to ensure that new investigators can navigate the increasingly complex research system
- Design new and improved clinical research informatics tools
- Assemble interdisciplinary teams that cover the complete spectrum of medical research
- Forge new partnerships with private and public health care organizations
In other words, Congress wants to see tangible evidence in their doctors’ offices of how the billions they’ve poured into bench science is benefiting their constituents. Each CTSA site is expected to provide functions that fall within the following cores:
- Development of Novel Clinical and Translational Methodologies
- Pilot and Collaborative Translational and Clinical Studies
- Biomedical Informatics
- Design, Biostatistics, and Clinical Research Ethics
- Regulatory Knowledge and Support
- Participant and Clinical Interactions Resources
- Community Engagement
- Translational Technologies and Resources
- Research Education, Training and Career Development
A core on industry partnerships and technology transfer should probably be added to this list. In future post, I’ll write up illustrative examples of what happens in these cores – I know a few of the titles are a bit opaque, and some of these really do cool stuff.
The consortium organization chart (which leaves out the multiple workgroups) gives the barest inkling of the complexity of this program. They plan to have 60 sites in the consortium. Take a look at the size of one committee with just 24 sites signed on thus far … and imagine adding representatives from 36 more institutions … and consider attending such a meeting.
And then there are the workgroups, such as the Clinical Research Ethics Workgroup. Not only do they have a Steering Committee, they have a COI Task Force, an Education Task Force, a Consultation Task Force, and an Operations Committee. Busy folks these.
Yes, a lot going on involving a cast of hundreds … inching close to a thousand (10 cores x 60 sites plus other site reps plus all the NIH personnel).
Yes, a lot of money on the table (~$1.1B for the 24 sites funded thus far), though the initial awardees will be giving back some of their funding: “The 2006 CTSA institutions that are currently receiving increases over their pre-CTSA program levels in excess of the new guidelines will experience a budget adjustment of -5% in FY 2008.” You can imagine the level of enthusiasm greeting this announcement or the notification that they will need to ask for less money in their competing renewals.
And carryover requests? What a joy. “Processing of a carryover request that does not include an OFM-approved FSR must include the approval of the Director or Deputy GMO, OGM.”
IMHO, though, CTSA sites do not need more money (sound of lightning striking). They need less to do, especially in terms of the bureaucracy & reporting burden but also in the overall program. Surely all 60 sites do not need to excel in (or even directly contribute to) all 10 areas of interest – especially now that NCRR plans to populate most of the consortium with small-to-medium sized institutions (but, looking again at the latest awardees, partnering with multiple other small-to-medium sized institutions). The general idea of a consortium is for participating institutions to complement rather than duplicate each other’s work and thus accomplish more together than they could individually. Much of the CTSA $ is directed back to the institution itself (eg, former GCRC functions, biostat & study design, pilot funding, career development, community engagement), but not everyone has the capacity or need to develop novel translational methodologies or significantly advance the field of biomedical informatics. Future CTSAs will need to increasingly emphasize a distinct role for pediatric research, which again may not be appropriate for all applicant sites. A subset of the Consortium with high-powered children’s hospitals and over-expressed Depts of Pediatrics should be able to manage translation of bench/clinical research from adult to pint-sized populations and serve as models for how institutions can better engage pediatric researchers on a scale appropriate to each.
I think the integration of the new sites in the Consortium will be an important learning process for NCRR and the rest of the team, hopefully smoothing the path for the remaining 36 institutions with winning lottery tickets (only 3 more chances to play if they keep handing out 12 awards for each RFA).