Clinical Trial-Specific Review Criteria

Purpose

NIH requires all applications involving one or more independent clinical trials to be submitted through a funding opportunity specifically designated as "Clinical Trial Required" or "Clinical Trial Optional." These clinical trial–specific funding opportunities include review criteria that focus on the rationale and study design and also include considerations for mechanistic studies, which will inform assessments of the proposed studies.

Applicants proposing to gain clinical trial research experience, but who will not be leading an independent clinical trial, should apply to a funding opportunity designated as "Clinical Trial Not Allowed" or "Independent Clinical Trial Not Allowed". These funding opportunities also include several review criteria questions focused on how the applicant will receive training in the conduct and design of clinical trial research.

The goal of this policy is to ensure that key pieces of clinical trial-specific information are submitted with each application and that reviewers appropriately consider this clinical trial-related information. Implementing more rigorous review criteria for evaluating clinical trial applications will ensure the highest likelihood of translating research results into knowledge that will improve human health.

Policy Implementation

Funding Opportunities that accept clinical trials include the following additional review criteria in Section V. Application Review Information. 

Research (R) Awards

Scored Review Factors:

• Factor 1: Importance of the Research (Significance, Innovation)
• Factor 2: Rigor and Feasibility (Approach)
• Factor 3: Expertise and Resources (Investigator, Environment)
  • To be evaluated as either sufficient for the proposed research or not (in which case reviewers must provide an explanation)

Additional Review Criteria:

• Human Subject Protections

For more details, see the Simplified Peer Review Framework page. 

Individual Career Development (K) Awards

Scored Review Criteria:

• Candidate
• Research Plan
• Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)
• Environment & Institutional Commitment to the Candidate

Additional Review Criteria:

• Study Timeline