Pre-Clinical & Clinical Concept Award

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

 

About the Award

HCC 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). 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. 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 HCC. Awarded PIs are expected to obtain regulatory approvals [e.g., IACUC, IRB] within six month. Release of funds will be contingent upon successful IRB/IACUC approval and all applicable human and animal subject protocols have been sent to Ms. Diane Wallace at wallacdm@musc.edu. Any extensions will require prior approval. All publications derived from this funding must site the HCC’s Cancer Center Support Grant (P30 CA138313).

Eligibility

  • Proposed research must be cancer relevant.
  • All MUSC faculty members are eligible
  • 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 info (previously published or determined at MUSC).
  • All PIs must commit to participate in fundraising efforts for the 2019 Hollings bike ride event before November 2019.

Timelines

Full applications are due by 5:00pm on Friday, August 3rd, 2018. Please send one PDF file of the application packet via email to Laura Andrews (areccola@musc.edu). Applications will be peer-reviewed by mid-September. Notifications of awards will be made in early October, 2018. The earliest anticipated start date is November 1, 2018, depending on the status of human and animal studies protocol approvals.

Evaluation

Each full application will be assigned to both internal and external reviewers who have substantial expertise in cancer research and in reviewing grants. Proposals will also be reviewed by the HCC Biostatistics Shared Resource (BSR). Proposals involving clinical trials and/or animal studies require consultation with HCC BSR Biostatisticians at least 2 weeks prior to submission of proposals (Dr. Betsy Hill, Director, BSR: hille@musc.edu). Collaborations between investigators in the clinical sciences, basic sciences and/or population sciences are strongly encouraged. External collaborators are permitted, but all funds must remain within MUSC. Trials that address outcomes that interface with cancer prevention and control studies are also encouraged.

Review criteria will 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 external peer-reviewed grant funding;
  • Projects involving transdisciplinary, team-based coordination and collaboration will be prioritized;
  • Active participation in HCC programs; and
  • The scientific plans for each proposal must also describe how the funds will provide study data that is critical to the future development of an investigator initiated clinical trial.
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