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Clinical and translational plan to be coordinated by Brady, Laken, Sullivan and Schachte

In October the National Institutes of Health announced a Roadmap initiative to transform the way the entire nation thinks about, prepares for, and carries out clinical and translational research. The Institutional Clinical and Translational Science Awards (CTSA) Program will be coordinated by the National Center for Research Resources (NCRR). An institution may participate in one CTSA proposal.

MUSC Vice President & Provost John Raymond and Vice President & Dean Jerry Reves designated Dr. Kathleen Brady, Program Director of the General Clinical Research Center (GCRC), to coordinate the institutional CTSA effort, in conjunction with Dr. Marilyn Laken, Director of the Office of Special Initiatives, Dr. Joann Sullivan, Director of Grants Development, and Ms. Peggy Schachte, Director of the Office of Research Development.

In a message to the MUSC research community on November 5, Drs. Reves and Raymond said, "This initiative is being developed by NIH to address the need for change in the clinical research enterprise and to transform the way that academic medical centers educate, encourage, support, and reward individuals and groups in this arena . . . We know this will be a complex, exciting, challenging process.  We look forward to enlisting the broadest possible participation in this transformative process, and we are committed to optimizing this opportunity to ensure the brightest future for MUSC, our outstanding faculty and trainees, and the people of South Carolina."

A central element of the CTSA initiative is the General Clinical Research Centers program. Another key element is an academic home that includes degree-granting program(s) in clinical research. MUSC is fortunate in having a GCRC, a thriving Master of Science in Clinical Research program, and a new Roadmap T32 training grant for medical and other health professional students in clinical and translational research. These features will be integrated into MUSC's CTSA plan.

The first step will be to prepare a new planning grant application (P20) to be submitted in April 2006.  The next step will be submission of the competing continuation application (M01) for the GCRC by October 1, 2006.  NIH is phasing out free-standing GCRC awards and folding them into the new CTSA awards.  MUSC's GCRC is eligible for up to 3 years of continued funding. Competitive renewal will augment the total dollars available to MUSC via the CTSA mechanism.

MUSC plans to submit a competitive CTSA proposal (U54) in response to NIH's second call for proposals—a likely 2007 submission. NIH will re-issue the U54 RFA periodically with a goal of achieving a critical mass of ~60 sites by 2012.

The shape and leadership of MUSC's U54 proposal will be determined by the participatory planning process that part of the P20 grant to be submitted in April 2006.  Two focus groups have developed a roster of strengths, weaknesses, opportunities and threats, which will be evaluated and prioritized during January as the basis for ongoing discussion, needs assessment and strategic planning to develop an "academic home for clinical and translational research."

For further information, please contact Dr. Kathleen Brady at bradyk@musc.edu or Peggy Schachte at schachte@musc.edu.  Guidance for the CTSA initiative is contained in the two Requests for Applications and additional documents posted on the NCRR web site at http://www.ncrr.nih.gov.


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