Clinical Trials Program

The James Graham Brown Cancer Center's Clinical Research Program is a multi-faceted Clinical Trials Program, including therapeutic and non-therapeutic clinical trials, Biorepository, Data & Safety Monitoring CommitteeClinical & Scientific Review Committee, and Clinical Trials Oversight Committee.

Clinical Trials Program

The Clinical Trials Program (“CTP”) is under the leadership of our Deputy Director, Jason Chesney, M.D., Ph.D., and our Associate Director of Clinical Research and Executive Director of BCC (Operations), Karen Carter, R.N.  The CTP has 26 full-time staff members, including managers, clinical research nurses and coordinators, biorepository technicians, and regulatory and financial staff.  At any given time, the CTP manages 100-125 open phase I-III trials involving participation by over 750 cancer patients.  This suite of trials consists of investigator-initiated trials generated by UofL oncologists, National Cancer Institute cooperative group trials and pharmaceutical industry-sponsored trials.  This core is essential to the overall mission of the Cancer Center serving to not only provide access to cutting-edge new therapies for our patients but also to function as the main interface between our cancer researchers and our patients.  We believe that the human experiment is the only experiment that will ultimately reduce the morbidity and mortality of cancer.

CTP staff research nurses and coordinators are embedded in the medical clinics conducted at the BCC, and participate in the BCC multidisciplinary conferences that review plans of care for the patients.  These multidisciplinary settings include lung, breast, GI, head-and-neck, melanoma, hematologic, and other cancer types.   As part of the BCC process to ensure timely creation of plans of care, CTP staff members pre-screen the clinic patients to identify potential trial candidates.  Working closely with the UofL faculty physicians/investigators, the CTP staff members are responsible for the ethical conduct of the trials, ensuring high-integrity data, as well as compassionate and respectful treatment of the cancer subjects.

The CTP partners with KentuckyOne Health in the conduct of these trials.  For optimal performance of the trial as well as optimal provision of services to these cancer patients, CTP research nurses and coordinators work closely with KentuckyOne Health employees, for example, highly skilled infusion nurses, nurse clinicians, social workers, and others.   CTP staff work closely with hospital research offices to review new oncology clinical trials, with the mutual, patient-oriented goal of opening these trials to enrollment as quickly as possible.

Data & Safety Monitoring Committee (DSMC)

The DSMC is charged with oversight of BCC clinical trials, including the review of relevant adverse and serious adverse events.  Its intent is not to duplicate similar reviews that may be performed by sponsor-retained independent groups.  Its intent is, however, to review site-specific serious adverse events for industry-sponsored and cooperative group trials, as well as to review all grades of adverse events for the robust BCC investigator-initiated clinical trial program.  The DSMC recommends actions to the Principal Investigator, which could include, for example, continuing or holding enrollment to the trial.  The DSMC is administered by the CTP, and meets quarterly or more frequently as needed.  Upon request, the DSMC provides this service for other investigators as well, who may have investigator-initiated clinical trials that do not involve BCC patients. Members of the DSMC include the Director and Deputy Director of the Cancer Center, as well as oncologists, scientists, biostatisticians, and CTP staff.

Clinical and Scientific Review Committee (CSRC)

The CSRC is comprised of multiple disciplines, including biostatisticians and oncology physicians.   All clinical trials intended to be opened at the BCC are reviewed by the CSRC for scientific merit.  The CSRC review is conducted prior to submission to the IRB.  Any proposed clinical trial rejected by the CSRC will not proceed.  The CSRC is administered by the CTP, and meets monthly.

Clinical Trials Oversight Committee (CTOC)

The CTOC, led by the Cancer Center Director, Dr. Donald Miller, is charged with prioritizing clinical trials in terms of clinical need and innovation in order to ensure that the available resources are used to the greatest benefit to our cancer patients.

The James Graham Brown Cancer Center Clinical Trials Office (not in order):  Stacy Baum, Sarah Bernstein, Danyelle Clark, Karen Ellis, David Figg, Katie Golladay, Melissa Hall, Anastasi Harper, Belma Kantardzic, Christi Kirby, Glenda Marker, Margaret Oechsli, Teresa Roberts, Jennifer Schoenbachler, Andrei Smolenkov, Cindi Swartz (not pictured), Taymie Collins (not pictured), Kathleen Coons, Carol Jensen, Manahil Khan, Stephanie Schemke, Lauren Tucker, Michael Weise (not pictured), Alicia Lutz, Karen Carter and Jason Chesney.