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Clinical Trials Office

About

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.

Medical Director, Hollings Clinical Trials Office
Chair, MUSC Radiation Medicine
Professor, College of Medicine
mail marshadt@musc.edu View Provider Profile open_in_new

As a senior clinical investigator, David Marshall, M.D., leads the Hollings clinical trials office and mentors Hollings investigators to support the growth and high-performance of Hollings clinical trials. As the chair of Radiation Medicine, contact PI for the MUSC NCI Community Oncology Research Program (NCORP), and with over a decade of service on the IRB, Marshall helps integrate clinical and research activities within MUSC and MUSC's statewide partners.

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Tricia Adrales Bentz, MHA, MHS-HIA

Administrative Director, Hollings Clinical Trials Office
mail adraleta@musc.edu

Tricia Adrales Bentz, MHA, MHS-HIA, oversees the Hollings Clinical Trials Office which provides centralized clinical, regulatory and financial support services to Hollings investigators. She leads initiatives to expand patient access to innovative cancer clinical trials and promote high quality assurance and clinical research education services. She obtained her masters in health administration and health information management and has over 20 years of oncology research experience.

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John Kaczmar, M.D.

Deputy Medical Director, Hollings Clinical Trials Office
Research Director, Hematology & Oncology Division
Director, Anderson Advanced Cancer Therapy Clinic
Associate Professor, College of Medicine
mail kaczmar@musc.edu View Provider Profile open_in_new

John Kaczmar, M.D., is the Clinical Trials Office Deputy Medical Director and Director of the Phase 1 Clinical Tials Program at MUSC Hollings Cancer Center. Dr. Kaczmar also serves as Director of the Anderson Advanced Cancer Therapy Clinic which is a specialized unit that provides a team of clinicians who are completely dedicated to the needs of patients participating in Phase 1 clinical trials. Dr. Kaczmar is a medical oncologist who specializes in caring for patients with head and neck cancers.

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Katherine Vosburgh, BSN, RN

Deputy Administrative Director, Hollings Clinical Trials Office
mail vosburgh@musc.edu

Katherine Vosburgh, BSN, RN, engages in clinical trial activities across all CTO Administrative and Clinical Operation Units, and supports executive level functions regarding all oncology clinical research activities at Hollings, Hollings satellite sites, MUSC Health Regional Health Network (RHN) sites, and MUSC NCI Community Oncology Research Program (NCORP) affiliate sites. She supports Hollings leadership in the development and implementation of initiatives to enhance trial accrual, trial time to activation, and quality assurance.

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CTO-Supported Featured Programs

MUSC NCI Community Oncology Research Program

MUSC holds a NCI Community Oncology Research Program (NCORP) grant, which 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, improving access to quality care and improving outcomes for everyone, no matter where they live.

The Clinical Trials Office provides centralized IRB and quality assurance services to six community cancer centers serving communities throughout South Carolina, including rural areas. 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. 

 

Clinical Trials Search

Our patients have access to over 200 clinical trials that target virtually every type of cancer.

Find a clinical trial

Publication Acknowledgment

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)."