Transplantation Statistical and Clinical Coordinating Center (T-SCCC) (U01, Clinical Trial Not Allowed)
NIH published the funding opportunity announcement (FOA) RFA-AI-22-057, Transplantation Statistical and Clinical Coordinating Center (T-SCCC) (U01, Clinical Trial Not Allowed) on August 9, 2022.
Updated October 31, 2022. We added the second through fifth questions below.
Per the RFA, the T-SCCC will be expected to support approximately 40 active clinical trials, which may be in development, enrolling, in follow-up, or in analysis and manuscript preparation. We do not expect that 40 studies will be enrolling simultaneously. Most of the trials in the transplant portfolio are conducted under investigational new drug (IND) applications or investigational device exemptions (IDE). Target accrual ranges from 10 to several hundred participants, and study duration ranges from approximately three to seven years.
In addition to the clinical aspects of the trial, all trials, whether interventional or observational, include in-depth studies of immunologic mechanisms utilizing a range of state-of the-art laboratory technologies and requiring extensive data and specimen collection and sophisticated statistical analysis approaches.