The IOM wants to know how you feel about CTSAs (say what?)

By Kristin Schneeman, Program Director, FasterCures

Have you ever heard of a CTSA?  How about NCATS?  Does this feel a little like a word game – how many acronyms can you make out of these letters?

CTSAs are Clinical and Translational Science Awards, a significant program at the National Institutes of Health to fund – you guessed it – translational and clinical science and resources (as distinct from the more basic discovery science NIH has historically supported) at the nation’s most prominent academic research institutions, 60 in all, across the entire country. NCATS is the National Center for Advancing Translational Science, the newest Center at NIH which was created to “catalyze the generation of innovative methods and technologies” to support the translation of promising basic discoveries into new diagnostics and therapeutics for patients.

Last fall, NCATS asked the Institute of Medicine to conduct a review of the CTSA program, which at $461 million is the largest component of NCATS’ $575 million budget and its assets. I attended the most recent committee meeting at the end of January, which focused to a significant degree on the CTSAs’ “community engagement.” There was not much clarity about what “communities” were supposed to be engaged – in most cases they seem to be the geographic communities in which the CTSAs are located, but in some cases they seem to be the patient communities that researchers are interested in studying, which may or may not be local. Community engagement activities and research were in previous years required components of CTSA applications but are no longer; that was the source of some consternation at the meeting, with speakers lamenting that relationships painstakingly built over the course of the first five plus years of the program were at risk (and that new ones would not be a priority) if they aren’t a requirement of funding. Among the most eloquent speakers was Bray Patrick-Lake of the Clinical Trials Transformation Initiative, herself a patient advocate, who said trust and relationship-building are long-term endeavors, and that academic institutions need to invest in patient groups and “not just come running when you need them for a grant.”

Also notable at this meeting was the lack of focus on what might be done with the CTSAs as a network, as opposed to how the individual institutions are progressing and evolving. This does seem to have been taken up at previous IOM meetings as part of this review, but it was markedly absent during the discussions about future directions for the program that wrapped up this particular day. NCATS itself has made a principle for the next stage of the program that “the whole must be greater than the sum of its parts,” and many observers believe that great things could be achieved by connecting all these major institutions and allowing stakeholders both internal and external to better understand and access the expertise and resources that reside in them. There is a relatively new Coordinating Center which has begun working on developing shared resources such as IRBshare, Contractshare, and the Research Electronic Data Capture (REDCap) platform, which could benefit external stakeholders as well as the CTSAs themselves.

The IOM is accepting comments from the public about the CTSAs until March 1st.  We encourage you to take a look at the questions and to consider commenting.  Even if you aren’t familiar with the CTSAs, that might be worthy of comment in and of itself. Here are a few of the questions we’re focused on:

• Are potential stakeholders aware of the resources available through the CTSA Program and are there barriers to use of those resources?
• Have the CTSA institutions, individually and collectively, played an appropriate and adequate role in involving and interacting with community organizations and patient advocacy groups? 
• Does the balance of CTSA Program efforts across the continuum of research from first phase studies in humans to clinical trials to population-based research on health outcomes and comparative effectiveness need to shift?
• What do you see as successes, challenges, and future directions of the CTSA Program?