To:      Cancer Center PI’s who have investigator-initiated pre-clinical to clinical aspirations

From:  Barbara Kurth, Ph.D. Clinical Trials Scientist

I am the new Clinical Trials Scientist for the CTO and my role is to encourage the development of investigator initiated trials and to deal with the regulatory process in getting a trial open.   For the time being, my phone # is 924-0436. My email address is bek4e@virginia.edu. I am eagerly anticipating hearing from all of you.

Initial Steps for Clinical Trials Scientist Assistance in Investigator-Initiated Clinical Trials

  1. The Principal Investigator must first present the idea for the clinical trial to Geoffrey Weiss for funding mechanisms and use of Cancer Center resources.
  2. The Principal Investigator or Sub-Investigator must present the idea for the clinical trial to Barbara Kurth by email.
  3. The Principal Investigator or Sub-Investigator must meet directly with Barbara for a minimum of 30 minutes to answer questions about study basics:
          - Study goals 
          - Patient population
          - Timeline
  4. Barbara will develop a study outline to help determine thefeasibility of the trial with Gina Petroni, Peter Waldron and the PI or Sub-PI.

Available Services for Investigator-Initiated Studies

Preliminary consultation
Preparing a study outline
A feasibility consultation
Preparing a Letter of Intent
Preparing a protocol (for PRC, HIC, GCRC)
Revising a protocol (for PRC, HIC, GCRC)
Preparing Case Report Forms
Preparing an IND application
Preparing a grant application