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.

diagram showing the process of clinical trial development, with findings from research programs moving through the steps of the Hollings Advisory for Rapid Translation, which helps move concepts forward into investigator initiated trials

Trial development steps

Expand the buttons below for further details on the steps involved in clinical trial development and ways that HART can assist with the process. If you would like 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, DFGs, Sponsor Investigator Support Unit (SISU), and Biostatistics Shared Resource (BSR), 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 BSR 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.

If your study is receiving funding or other support from an outside agency (i.e., pharmaceutical company, etc.), the SISU will facilitate any agreements (i.e., confidentiality disclosure/study contract) with the MUSC Office of Research and Sponsored Programs (ORSP).

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 BSR. The SISU and BSR will closely monitor the input of patient information and ensure that the information is complete and entered in a timely manner.

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.

HART Leadership

Drs. Lockhart and Wrangle 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.