Case Study: How AACI’s Clinical Research Initiative Helps to Improve Clinical Trial Management

G  Radakovic

Dr. Gospova Radakovic, Director, Office of Clinical Research, University of Virginia Cancer Center

Over the past year, Dr. Gospova Radakovic, director of the Office of Clinical Research at the University of Virginia (UVA) Cancer Center, has been searching for ways to shorten UVA’s clinical trials activation timeline. At the 6th Annual AACI CRI Meeting in Chicago, Dr. Radakovic attended a session entitled, “Death by Startup: Clinical Trial Activation Challenges”, to learn about how her colleagues communicate with the multiple institutional departments (e.g., regulatory, finance administration, budgeting and contracting, pharmacy, pathology, radiology, laboratory, clinical staff) that are involved in the review and approval of oncology trials.

One of the session’s panelists, Dr. Vicki Keedy, Assistant Medical Director, Clinical Trials Shared Resource at Vanderbilt-Ingram Cancer Center, talked about Vanderbilt’s Clinical Research Implementation Committee (CRIC). CRIC is comprised of permanent members representing various departments–bio-specimen, budget, clinic, infusion, patient management, pharmacy, radiology, regulatory–and ad hoc members from departments including pathology, ophthalmology and dermatology. It meets bimonthly to discuss new protocols and to address questions each department may have about opening and conducting a trial. CRIC meetings are an opportunity to address concerns prior to a trial being reviewed by the institution’s regulatory committees. Since the implementation of the bimonthly committee reviews, Vanderbilt has minimized delays in its trial review process.

When Dr. Radakovic returned to UVA, she created a CRIC committee focused on the following objectives:

  • Provide oversight for oncology trial activation.
  • Clarify resources needed for trial implementation and coordination.
  • Facilitate communication between all internal stakeholders working with the trial, from trial receipt to trial implementation.
  • Assign accountability for all tasks necessary for trial activation and completion.

Dr. Radakovic chairs the bimonthly UVA Cancer Center CRIC meetings which include investigational pharmacists, research nurses, regulatory coordinators, budget managers, and research group managers. Since the committee’s formation, UVA has seen improvement in the Clinical Research Office’s communications with internal stakeholders, leading to smoother and more productive site initiation processes. Also, the CRIC review has helped to prioritize the application of limited trial resources, leading to a broader range of available trials.

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