In 2014, the Medical School Research Board of Directors (RBOD) identified the strategic priority of transforming clinical trials at the University of Michigan by 2018. The RBOD-endorsed enterprise goal is to create the new knowledge needed to improve clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical trials. The Clinical Trials Subcommittee, a committee of the Research Board of Directors, was charged with working with the Medical School Office of Research to address the six strategies to achieve our enterprise goal. Collectively, this initiative is called the Clinical Trials Transformation. The Medical School Office of Research and the Michigan Institute for Clinical & Health Research (MICHR) joined forces to implement a new organizational structure, common infrastructure, and redesigned processes necessary for transforming the clinical trials enterprise by 2018. The organizational structure includes the establishment of a central Clinical Trials Support Office (CTSO) and 7 trans-departmental Clinical Trials Support Units (CTSUs) that are aligned around common areas of research. The six strategies to achieve this goal include:
- Foster a UMHS culture that values, rewards, and supports clinical trial activities.
- Develop a coordinated, sustainable infrastructure that supports operational excellence throughout the life cycle of clinical trials.
- Develop a highly trained, innovative, and skilled workforce, including those who initiate and those who conduct clinical trials.
- Translate U-M discoveries into clinical trials.
- Fully integrate the clinical trials enterprise and the clinical care delivery system.
- Demonstrate the value of clinical trials to patients, families, and society.
The Clinical Trials Subcommittee was tasked by the Dean and the Medical School’s Research Board of Directors with conducting the discovery and directing the execution of the new infrastructure and processes necessary for transforming our clinical trials enterprise by 2018. Clinical Trials Subcommittee is chaired by Dr. Anna Lok and vice-chaired by Dr. George Mashour, Director of MICHR. The Office of Research is a strong partner with MICHR on the Fast Forward Clinical Trial Transformation Initiative.