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Clinical Trial Development

In order to increase clinical research and clinical trial development, Hollings leadership created the Hollings Advisory for Rapid Translation (HART). The HART Program brings an expert team in trial concept development directly to faculty members seeking to translate their findings to the clinic. HART provides investigators mentorship in navigating the decision points from concept development to implementation and ensures the investigator is connected to appropriate resources to help reduce barriers to protocol activation.

Trial Development Steps

Expand the buttons below for details on clinical trial development and ways that HART can assist with the process. To request assistance with a trial concept, reach out at the link below.

HART will help review the trial concept and connect the PI to members of the TCTs, Clinical Research Groups, Sponsor Investigator Support Unit (SISU), and Data Science Shared Resource (DSSR), all of which provide valuable insight into the development of a feasible and meritorious clinical trial.

The current version of the NIH-FDA protocol template is used to develop the study protocol. The SISU and Data Science Shared Resource work closely with the PI to draft sections of the protocol and support revisions of the protocol and related regulatory documents as the study moves through the regulatory review process.

Once completed, the SISU will submit the protocol and any other documents (i.e., consent forms, patient facing materials) to the FDA, PRC, IRB and/or any other applicable committees/boards for approval. The SISU will provide you with a timeline for when your study will be reviewed and activated for enrollment.

It is important to work with the SISU and our Clinical Trials Office pre-award finance team to develop a budget for the clinical trial. Our team can help investigators obtain a required coverage analysis to determine what are research specific procedures versus standard of care charges that can be billed to the study patient. Additionally, the team can build a draft budget that matches the coverage analysis and anticipated enrollment plan.

While it is recommended that the investigator seek external or intramural funding to support the clinical trial, Hollings Cancer Center has established the Clinical Trials Investment Program (CTIP) to support high priority investigator-initiated treatment trials that have financial feasibility concerns. Eligibility for funding is reviewed by HART leaders. To request CTIP funding, submit an application via the InfoReady portal.

Once your study has been approved, the SISU will ensure that the appropriate clinical study team is trained and supported for patient enrollment and interventions on your study. All patients who are enrolled will be entered into the REDCap electronic data capture system developed by the DSSR. The SISU and DSSR will closely monitor the input of patient information and ensure that the information is complete and entered in a timely manner.

Request Assistance

If you have questions or need further assistance with a clinical trial concept, please contact us and someone from the HART team will reach out to you. An MUSC NetID and password are required.

Contact HART

HART Leadership

John M. Wrangle, M.D., MPH

HART Scientific Director, MUSC Hollings Cancer Center
Burtschy Family Chair in Cancer Research
Associate Professor, Hematology and Oncology
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My research is focused on developing novel immunotherapies for non-small cell lung cancer. Immunotherapy has become a mainstay of treatment for non-small cell lung cancer’s (NSCLC), yet PD-1/PD-L1 directed immune checkpoint blockade alone or in combination with chemotherapy fails to yield durable responses in the large majority of treated patients. Our understanding of immunotherapy’s success or failure on an individual basis must evolve rapidly to extend benefit to a great proportion of treated patients.

As scientific director of the Hollings Advisory for Rapid Translation (HART), I provide consultation to investigators as they navigate the trial development process. Whether it is connecting to potential funding partners or facilitating collaboration among other researchers at MUSC or other cancer centers, HART supports the efficient activation of new investigator-initiated clinical trials.

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Ozgur Sahin, Ph.D.

Co-Leader, Cancer Biology & Immunology Program, Hollings Cancer Center
HART Program Director, Basic Science Translation, Hollings Cancer Center
SC SmartState Endowed Chair for Lipidomics, Pathobiology & Therapy
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Ozgur Sahin, Ph.D., is a professor and endowed chair in Lipidomics, Pathobiology and Therapy in the Department of Biochemistry & Molecular Biology and Hollings Cancer Center at the Medical University of South Carolina (MUSC). Furthermore, I am an American Cancer Society (ACS) Research Scholar; founder, and president of LoxiGen, Inc.; and co-founder, and manager of OncoCube Therapeutics, LLC. My laboratory focuses on elucidating the mechanisms of cancer therapeutics, drug resistance and metastasis, mainly in breast cancer. We combine our expertise in cancer cell biology, functional transcriptomics/bioinformatics, and drug discovery, with those of the experts from the medicinal chemistry, proteomics, and medical oncology fields to target the most aggressive cancers.

Elizabeth Hill, Ph.D.

Biostatistics Director, Data Science Shared Resource, MUSC Hollings Cancer Center
HART Program Director, Clinical Trials Biostatistics, MUSC Hollings Cancer Center
Professor, Public Health Sciences
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I have been a member of Hollings Cancer Center’s Data Science Shared Resource (DSSR) since 2007 and was appointed the DSSR’s director in 2017. In January 2020 I joined Eli Lilly and Company where I served as Statistical Director of the Early Phase Oncology Program, with direct oversight of the development and conduct of Lilly’s early phase (largely first-in-human) portfolio. I returned to MUSC in January 2021 to resume directorship of the DSSR. In my 15+ years of DSSR affiliation, I have collaborated with MUSC cancer center investigators spanning the oncology research continuum from designing bench experiments and early phase clinical trials to analyzing data from laboratories and large-scale epidemiologic databases. I have served as the biostatistics core director (PI or co-PI) for both multi-project (P01 and U54) and center grants (P30s), and I have a strong track record of continuous funding as co-investigator with numerous cancer center investigators.

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