Opening a Clinical Trial at U.Va. Cancer Center

Services Available to the Investigator

Our office boasts a number of talented and dedicated employees who stand poised to assist you with the opening, management, and closing of clinical trials.

We currently employ CRCs who are intelligent, knowledgeable, degreed, and well-trained in the art and science of clinical trial management. Please click  here should you desire more information regarding our CRCs.  The services they provide include: study start-up, patient screening and enrollment, determining protocol-required assessments, data acquisition and submission, and sample acquisition and shipment.

Assistance Available for Design and Writing of Trials

Barbara Kurth is the Clinical Trials Scientist for the CTO. Her current phone number is 924-0436.

Initial Steps for Clinical Trials Scientist Assistance in Investigator-Initiated Clinical Trials:
The Principal Investigator or Sub-Investigator must present the idea for the clinical trial to Barbara Kurth by email.

The Principal Investigator or Sub-Investigator must meet directly with Barbara to answer questions about study basics:

  • Study goals
  • Patient population
  • Timeline

A committee will develop a study outline to help determine the feasibility of the trial.

Available Services for Investigator-Initiated Studies from the Clinical Trials Scientist:

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

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Assistance with the Protocol Review Committee/Data Safety Monitoring Process

Gina Petroni, PhD, is an Assistant Professor of Biostatistics and the Cancer Center Biostatician. Her areas of expertise include Cancer Center clinical trial design, conduct, and analysis.

Catherine Reniere , MA, is the PRC Coordinator at the  Protocol Review Committee (PRC) . It is she that an investigator sees to acquire a Protocol Review Submission form, a PRC Review Template, and a Data Safety Monitoring Plan Review Template. She is an extremely knowledgeable member of the team and is always willing to field questions and offer advice and substantive assistance. She can be reached at 243-6438. 

Existing Cooperative Group Trials

If you would like to open a trial in a Cooperative Group that is already open at UVA, you must first gain approval from the physician who is the program director for that Cooperative Group. Click on the links below to contact that physician by e-mail.

Cooperative Group
Program Director
Children's Oncology Group
Gynecology Oncology Group
Eastern Cooperative Oncology Group
Radiation Therapy Oncology Group

Once the program director has approved the protocol to be opened, it must be submitted to the IRB-HSR.

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Opening New Pharmaceutical Protocols

Please note: The CTO cannot assist with opening a protocol until it has passed the PRC.

Submit trial to the Protocol Review and Monitoring Committee .

Submit trial to the Institutional Review Board for Health Sciences Research.

Budgeting a pharmaceutical trial
Developing a budget for a pharmaceutical trial is a combined effort between the physician investigator and the CTO.

Once a protocol has passed the PRC, the CTO will work up a budget, and determine all costs of doing the trial, including how much it will cost for the CTO to run the trial. For more information about the budgeting process, please contact the CTO Clinical Manager.

Grants and Contracts
Once the budget is developed, negotiations are conducted between the investigator and the pharmaceutical company or CRO, and the Office of Grants and Contracts. For more information about contract negotiations, please contact the Office of Grants and Contracts, or your department/division administrator.

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Recruiting Patients for Trials

At the UVA Cancer Center, patients are recruited through various means. In general, patients are recruited by MD investigators and their nurse coordinators from patient populations seen in their clinics. Our website provides contact information as well as a list of available trials for patients and health care providers who are interested in cancer clinical trials.   The University of Virginia Institutional Review Board for Health Sciences Research (IRB-HSR)   must approve any additional marketing of trials.