Concept Checklists
Biomarker Assays and Imaging Tests Proposals
A document describing the characteristics and performance of each biomarker assay and imaging test proposed for funding, and its role in the trial is required as part of the proposal package. Applicants should refer to the Concept Checklist for Large, Randomized Phase 2 or Phase 3 Trials with Essential Biomarker Assays or Imaging Tests for instructions on what information is needed.
- Concept Checklist for Large, Randomized Phase 2 or Phase 3 Trials with Essential Biomarker Assays or Imaging Tests
- Concept Checklist for Large, Randomized Phase 2 or Phase 3 Trials with Essential Biomarker Assays or Imaging Tests
Quality of Life Proposals
A document is required describing the characteristics and performance of each QOL component and/or instrument proposed for funding, and its role in the trial. Applicants should refer to the Concept Checklist for Phase 3 Trials with QOL Components for instructions on what information is needed.
- Concept Checklist for Phase 3 Trials with QOL Components
- Concept Checklist for Phase 3 Trials with QOL Components
Cost Effectiveness Analysis
A document is required describing the rationale and justification of the CEA proposal for funding. The CEA proposal should be a secondary endpoint of the parent study. Applicants should refer to the Concept Checklist for Randomized Phase 3 Clinical Trials with a Control Arm and Cost-Effectiveness Analysis (CEA) Component(s) for instructions on what information is needed.
