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Review Criteria
TRANSLATIONAL RESEARCH INITIATIVE
REVIEW CRITERIA
Review criteria for LOI:
- Strong scientific hypothesis
- Supporting preliminary data and/or a strong rationale
- Innovative correlative studies
- Not duplicative
- Adequate patient accrual
- Ability to meet regulatory requirements
- Agent availability
- Industry sponsor concurs
- In 2002, 1/3 of LOIs for early clinical trials with CTEP IND agents were approved (solicited and unsolicited)
Review Criteria for Correlative Studies for TRI Support:
- Importance of proposed correlative hypothesis for further development of agent
- Biologic rationale for studying the target effect
- Relevant preclinical data behind hypothesis
- Rationale for selection of assay
- Technical performance characteristics of assay
- Investigator experience with the assay
- Comparability of results with other published data
- Impact on future studies
- Statistics for data analysis - prevalence of target, study power for chosen endpoint
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