The Case CCC is encouraging investigators to submit Letters of Intent (LOI) for Early Phase Clinical Research Support (EPCRS) funding. These in-house funds are available for the conduct of early phase clinical trials of relatively short duration. Priority will be given to trials which are developed jointly between University Hospitals and Cleveland Clinic with planned accrual at both institutions.
Please direct any questions and/or submit LOIs to the Clinical Research Office Director at kevin.hoy@case.edu.
The proposals are being accepted on a rolling basis subject to availability of funds.
Instructions
The Case Comprehensive Cancer Center (Case CCC) has budgeted funds for the conduct of early phase clinical trials of relatively short duration. The objectives are to identify and fund investigator-initiated trials, which meet the Cancer Center Support Grant and Case CCC requirements, entertain highly innovative and novel ideas, and which directly foster the mission of the Case CCC. These may be new trials under development or an existing investigator-initiated trial that is unfunded/under-funded. Priority will be given to trials that have been developed jointly between investigators at both hospital systems (University Hospitals and Cleveland Clinic), with planned accrual at both sites.
Case CCC Requirements
- The Principal Investigator will be a member (including Associate or Clinical Member) of the Case Comprehensive Cancer Center. Applications with a trainee as co-PI under the mentorship of a Cancer Center member are also encouraged.
- Submission of a Letter of Intent (LOI) of maximum of three-page project narrative including the following information: background; objectives; eligibility; methods (including study design and patient assessment table); endpoints/statistics; and assessment of feasibility including projected timelines.
- Submission of a draft/preliminary budget (not included in the three-page limit), with the expectation that (for studies performed at both UH and CCF), a single budget will be agreed to by both clinical sites.
- An institutional letter of support should be submitted along with the LOI, stating that additional funds (institutional and/or other, e.g. philanthropic support) will be available to supplement the Case CCC funding and ensure that the study is going to be financially feasible. Requests with matched commitments between the hospital sites and Case CCC will be given priority reviews.
- A plan for trial opening should be included. Time from EPCRS award memo to opening a trial to patient enrollment should not exceed 90 days. The expectation is that the study will complete accrual within three years from activation, except for two-stage design studies where 20 patients or fewer are expected.
Additional Information Regarding Funding/Budget
- Funding through this mechanism cannot overlap with peer-reviewed, cooperative, or industry funding.
- The budget should consist of two main components: 1) Pre-enrollment costs; 2) Per patient accrual costs. Both of these primarily consist of the cost of clinical-trials-unit personnel (research nurse, data manager, regulatory support person), though component #2 may include costs for imaging and/or biospecimen acquisition and analysis. Salary support for investigators, major equipment purchases, or travel funding is not available through this mechanism. Pre-enrollment costs may include costs of biostatistician time/effort, IND/IDE applications, and IRB fees in addition to CTU personnel time and effort. Protocol writer or project manager costs are not allowed, but support can be requested for these activities either through the hospital or cancer center.
- Distribution of payment from the Case CCC will be to the clinical trials units and will be based upon accrual (with the exception of startup costs). If funds are not spent for the purpose indicated, they will be returned without retention by the CTU.
- As noted above, the expectation is that the Case CCC and participating hospital(s) will cost-share through direct financial support, over and above in-kind cost-share in support of these trials.
Process for Review and Award
Applications will be reviewed and scored by a committee led by the Cancer Center’s Associate Director and Deputy Associate Director for Clinical Research, with recommendations for funding then sent to the Cancer Center’s Executive Committee. It is expected that applicants will receive feedback and a preliminary decision within 90 days following LOI submission. Final decisions will be based upon funding availability.