COVID-19 Trials Feasibility Review Committee Established

Michigan Medicine has many brilliant physicians and scientists with creative ideas on how to better treat or prevent COVID-19. Fortunately, there are fewer COVID-19 patients in our hospital than originally expected. We also have a limited number of study coordinators and trained personnel experienced with clinical trials in the ICU setting. With an average of one new trial coming in each week, the Clinical Trials Support Office Leadership has determined that it is necessary to prioritize trials that have the greatest likelihood of providing benefit to patients or the scientific community and that are the most feasible to implement from a logistics standpoint.

With the support of Dr. Rebecca Cunningham, Vice President for Research and Dr. Steven Kunkel, Executive Vice Dean for Research of the Medical School and Chief Scientific Officer for Michigan Medicine, we established the COVID-19 Trials Feasibility Review Committee (TRIFREC) to review and prioritize COVID-19 trials.

All COVID-19 clinical trials must be submitted to the UMOR COVID-19 Research Prioritization Committee. Once the review has been completed, PIs will receive a notification to:

1. Submit a CTSU Intake Form
2. Submit protocol and other documents to COVID-19 TRIFREC.

TRIFREC is expected to be able to generate priority scores, priority level (High/Medium/Low), and decisions to Proceed/Not Proceed within 5 business days from the receipt of a complete application.

Disclaimer: Approval from this panel does not mean a trial can start enrolling; rather, trials with feasibility approval will receive high priority support for activation.

Support for COVID-19 trials is provided through collaboration across CTSUs and MCRU, with patient consent coordination by the ACCST CTSU, sample collection and processing by MCRU, and financial and portfolio management remaining within a study team’s current CTSU.

To learn more about current and upcoming COVID-19 clinical trials at the University of Michigan, view the COVID-19 Research Index.

We are deeply appreciative of the hard work of many teams, and in particular, ACCST CTSU PIs and staff for implementing clinical trials at record speed at Michigan Medicine. As of April 14, 2020, we have enrolled a remarkable total of 50 patients in COVID-19 trials. We also want to thank our partners including ORSP, IRB, CRAO, and IDS for moving the process along expeditiously, as well as our clinical colleagues for fantastic collaboration and their outstanding care of COVID patients.

Questions or concerns about the Feasibility Review may be directed to Debra Tanton (debratan@med.umich.edu) or Peter Higgins (phiggins@med.umich.edu).