In March 2020, in recognition of the important coordinating role that Trial-CARE has played in enabling active support for complex clinical research at Washington University, Dr. Vedantham, Director of Trial-CARE, was appointed to lead the institutional COVID-19 Clinical Studies Committee (CCSC). The Committee’s activities are coordinated by Tera Jarvis, Trial-CARE Administrative Coordinator.

Membership on the Committee was deliberately assigned to promote constructive coordination among multidisciplinary clinical experts (from Infectious Diseases, Pulmonary & Critical Care, Emergency Medicine, Pathology & Immunology, and Anesthesiology) and important enablers of trial conduct (Trial-CARE project managers, CCS nurse coordinator manager, hospital system research compliance officers).

  • From March 2020 through December 2021, the Committee reviewed 232 investigator proposals for clinical studies related to COVID-19. This included 67 interventional clinical trials and 165 proposals for observational studies.
  • Committee review for interventional trials included an NIH study section-style trial review for scientific merit and feasibility, with detailed Committee feedback provided both to the investigator and to the IRB prior to its formal full board review. This process leveraged Trial-CARE’s expertise with supporting research teams and was important in increasing the quality of ongoing research within ICTS institutions, as it prompted improvements to the planned implementation of many studies.
  • Committee review for observational studies – which encompassed a broad range of meaningful research into the pandemic’s impact on various patient populations, health care workers, and community members – underwent a streamlined Committee screening process in parallel with (usually expedited) IRB review.

In late 2020, an additional ICTS-led COVID-19 research support committee was launched. The COVID-19 Research Prioritization Committee, led by Dr. Gregory Storch and Heather Wilkins, with participation from Dr. Suresh Vedantham, was formed as a multidisciplinary group of investigators. Once studies are approved by the Clinical Studies Committee and IRB, the Prioritization Committee evaluates them against other ongoing studies to determine enrollment priority.

For additional information about COVID-19 research at Washington University, please visit the ICTS site.