Clinical Trials Office

The MUSC Hollings Cancer Center Clinical Trials Office (CTO) provides a centralized office for the conduct of cancer clinical trials at the Medical University of South Carolina. The purpose of the CTO is to provide an effective and efficient infrastructure to support Hollings investigators in developing, implementing, and reporting on all cancer clinical research studies at MUSC.

The CTO provides clinical, regulatory, and administrative research services for more than 60 principal investigators. At any one time, the CTO manages approximately 475 trials — 200 active enrolling trials, 200 closed-to-accrual trials with patients in follow-up, and 75 pending trials in the approval process.

Major Functions

• Serve as a central clinical research information repository that facilitates center-wide communications, subject accrual tracking, and monitoring of the progression for all studies from inception to final publication.
• Assist Hollings investigators in the timely activation and administration of studies, including the preparations and communications required for scientific, ethical, financial, and operational reviews as well as ongoing support for annual regulatory reviews.
• Assist clinicians in screening and enrolling patients for clinical research studies.
• Coordinate and ensure the completion of patient-specific study requirements.
• Provide data management support for clinical research studies.
• Prepare medical and research records for internal and external quality and compliance audits.
• Provide training and education pertaining to the best practices in conducting clinical studies to clinical and CTO staff and new investigators.
• Communicate the availability of clinical studies to Hollings physicians, referring physicians, and the public.

Leadership 

 

David T. Marshall, M.D.

CTO Medical Director
Professor
Department of Radiation Oncology
marshadt@musc.edu

 

Tricia Adrales Bentz, MHA, MHS-HIA

CTO Administrative Director
843-792-1415
adraleta@musc.edu

CTO-Supported Featured Programs

MUSC NCI Minority-Underserved Community Oncology Research Program

MUSC holds one of only 14 NCI Minority-Underserved Community Oncology Research Program (NCORP) grants in the country, which it was initially awarded in 2014 and was competitively renewed in 2019. The goal of NCORP is to bring cancer clinical trials to individuals in their own communities. Given that MUSC’s patient population is more than 30% minority and/or underserved, MUSC was awarded a Minority-Underserved NCORP.

The aim of NCORP-MU is to facilitate minority and underserved participation in clinical research, integrate disparities research questions across all study types and settings, and accelerate knowledge transfer into clinical practice and health systems and organization. The Clinical Trials Office provides centralized IRB and quality assurance services to five community cancer centers serving rural and minority communities throughout South Carolina. By partnering with over 20 community oncologists, MUSC is able to increase patient access to cancer clinical trials within communities across the state.

Phase I Program

Hollings investigators have long participated in Phase I clinical trials. Under the direction of John Kaczmar, M.D., the Phase I program has supported numerous Phase I trials spanning from first-in-human and first-in-class to Phase IB. With support from MUSC Health, Phase I studies can be seamlessly implemented both inpatient and/or outpatient as needed. With a dedicated investigational drug pharmacy and a centralized clinical and translational research center, clinical and research services are available 24/7 and are supported by a dedicated team of Phase I physicians.

For more information about the Phase I program, please contact the program manager, Lilli Neal, at nealli@musc.edu.

Sponsor Investigator Support Unit

As an NCI-designated cancer center, investigators often develop or implement trials based on research conducted right here at Hollings. The Sponsor Investigator Support Unit (SISU) assists principal investigators with the study development process, including the development of the protocol, budget, operations manual, vendor management, multi-site management, and IND/IDE preparation and support. SISU services vary by study, and SISU staff work with various pharmaceutical companies.

For more information about the SISU, please contact Alan Brisendine at brisend@musc.edu.

Publication Acknowledgement

If you publish a manuscript including research supported by the Clinical Trials Office, Hollings recommends the following text be placed in the acknowledgment section: "Supported in part by the Clinical Trials Office, Hollings Cancer Center, Medical University of South Carolina (P30 CA138313)."