Pre-Clinical and Clinical Concepts Award

Clinical trials help develop new ways to prevent and treat cancer, providing participating patients with access to the most advanced treatments. MUSC Hollings Cancer Center provides support for development of pre-clinical trial and approved clinical trial concepts based on laboratory discoveries made at Hollings.

Purpose and Overview

Hollings leadership anticipates distributing awards up to $50,000 for one year. Funds may be requested for correlative science or for protocol-specific research support (i.e., CTO support). Sources of funding for the award include the Hollings Cancer Center Support Grant (P30 CA138313), fundraising from the LOWVELO bike ride, and other Hollings philanthropy/foundation accounts.

Awardees are required to submit a timeline showing when an investigator-initiated trial will be submitted to the IRB for review. In addition, a final progress report is required upon project completion including an outline of project results and clinical trials submitted and planned. Any no-cost extensions will require prior approval. If timely progress is not made throughout the award period and funds have not been fully expended by the end of the project period, the funds will be returned to the Hollings Cancer Center. Awarded PIs are expected to obtain regulatory approvals (e.g., IACUC, IRB) within three months of award notification. Release of funds will be contingent upon successful IRB/IACUC approval and having all applicable human and animal subject protocols sent to Brett Bechtol (bechtolb@musc.edu).

Eligibility

  • Proposed research must be cancer relevant.
  • All MUSC faculty members are eligible to apply.
  • Research can only take place at MUSC.
  • Clear demonstration of feasibility of the clinical application of applicant's investigational product (IP) including:
    • Source and availability of a clinical grade product (collaborations with pharmaceutical companies should provide approved LOI, concept invitation, etc.);
    • Anticipated path to IND (including citations from previous INDs for the same material, source from food products, etc.); and
    • Purity information (previously published or determined by study investigators).
  • All PIs and co-investigators are encouraged to participate as a registered rider in the annual LOWVELO bike ride event

Evaluation

Each application will be assigned to internal and external reviewers who have substantial expertise in cancer research and in reviewing grants. Proposals will also be reviewed by the Hollings Cancer Center Biostatistics Shared Resource (BSR). Proposals involving clinical trials and/or animal studies require consultation with Hollings Cancer Center BSR biostatisticians at least two weeks prior to submission of proposals (Dr. Hong Li [liho@musc.edu], Interim Director, Biostatistics Shared Resource). Collaborations between investigators in the clinical sciences, basic sciences, and/or population sciences are strongly encouraged. Trials that address outcomes that interface with cancer prevention and control studies are also encouraged.

Review criteria include:

  • Standard NIH criteria (significance, innovation, approach, and investigative team);         
  • For pre-clinical concepts, the likelihood of being translated to a successful LOI or externally-funded protocol;
  • Likelihood that preliminary results will lead to extramural grant funding;
  • Projects involving transdisciplinary, team-based coordination and collaboration will be prioritized;
  • Participation in Hollings Cancer Center programs (e.g., attend program meetings, participate in grant review panels, participate in annual research symposia);
  • The scientific plans must describe how the funds will provide study data that is critical to the future development of an investigator-initiated clinical trial.

Timelines

Full applications are due by 5 p.m. on Monday, March 9, 2020. Please email one PDF file of the application to Brett Bechtol (bechtolb@musc.edu). After peer review, notifications of award will be made, and the start date will be dependent on the status of human and animal studies protocol approvals. Applicants receiving a score just outside the funding range will be notified with the possibility of resubmitting their application for a subsequent RFA cycle.