Clinical Trial Development

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.

It is important to work with the SISU and our CTO 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 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.