Increasing the speed and efficiency of clinical research protocols—including multi-center studies—is a key goal of the CTRI. To help launch clinical trials, the CTRI is creating Rapid Response Trials Team (R2T2) services. R2T2 will assist investigators with all aspects of pre-launch study management, including planning, design, documentation preparation and feasibility assessments for projects. It will be part of CTRI's Center for Clinical Research (CCR) and will be formally launched later this year.
Charged with shepherding a proposed study from receipt of the protocol to study initiation, R2T2 brings people together very early to coordinate the myriad of regulatory, administrative and design tasks required before a study can begin. A project manager will be integrated into the trial, providing a simple, consistent and focused point of contact for investigators, and facilitating the development and implementation of well-designed studies. In addition to the project manager, the team can include the following:
- a regulatory
analyst to review the protocol and determine if there are any red flags and help decide if the project would benefit from a central IRB, an IRB reliance agreement or a commercial IRB;
budget and contracting analyst from the Office of Clinical Trial Administration;
CTRI informatics analyst to facilitate cohort exploration and identification and database creation;
biostatistician, if needed, to review design, especially for studies that have not been through peer review;
pharmacist to evaluate experimental pharmacy needs; and
nurse administrator for feasibility and safety.
The R2T2 Team formation can be initiated by a request through a variety of mechanisms, including the investigator using our online form, an IRB submission or request for a clinical trial agreement to the contracting office.
The team will meet with the investigator to review the protocol, assess potential hurdles and determine the best path forward to assure rapid initiation.
We are very excited about the creation of R2T2 as we continue to build our services to support clinical and translational research.
Gary S. Firestein, MD, Director of CTRI
Professor of Medicine, Dean and Associate Vice Chancellor of Translational Medicine
Phone: (858) 822-3824