Clinical Trial-Specific Review Criteria

All applicants proposing clinical trials or proposing to gain research experience in a clinical trial can learn about the additional review criteria found in the funding opportunity announcement (FOA) to ensure uniform application of clinical trial-specific review criteria.

Purpose

For due dates on or after January 25, 2018, NIH requires that all applications involving one or more independent clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designated as "Clinical Trial Required", "Clinical Trial Optional", or "Basic Experimental Studies with Humans Required." These clinical trial–specific FOAs include new review criteria questions 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 FOA designated as "Clinical Trial Not Allowed" or "Independent Clinical Trial Not Allowed". These FOAs also include several new 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 new and 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

New review criteria questions are effective for all applications proposing clinical trials or proposing to gain clinical trial research experience with due dates on or after January 25, 2018.
 

FOAs that accept clinical trials include additional review criteria questions in Section V. Application Review Information. New review criteria questions have been added to the following:

Research (R) Awards
Scored Review Criteria:

• Significance
• Investigator(s)
• Innovation
• Approach
• Environment

Additional Review Criteria:

• Study Timeline  

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  

FOAs that do not accept clinical trials but permit clinical trial research experience include additional review criteria questions in Section V. Application Review Information. New review criteria questions have been added to the following:

Individual Career Development (K) Awards
Scored Review Criteria:

• Research Plan
• Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

Fellowship (F) Awards
Scored Review Criteria:

• Sponsor(s), Collaborator(s), and Consultant(s)
• Research Training Plan

Training (T) Awards
Scored Review Criteria:

• Preceptors/Mentors

*Note that some D43 & K12 FOAs accept clinical trials and accordingly have additional review criteria questions.
 

Notices

• NOT-OD-18-109 Revision: The NIH Announces New Review Criteria for Career Development Award Applications Involving Clinical Trials 
• NOT-OD-17-118 The NIH Announces New Review Criteria for Research Project Applications Involving Clinical Trials
• NOT-OD-17-121 The NIH Announces New Review Criteria for Career Development Award Applications Involving Clinical Trials
• NOT-OD-17-122 The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship Applications Involving Research Experiences in Clinical Trials
• NOT-OD-17-123 The NIH Announces New Review Criteria for Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grants Involving Research Experiences in Clinical Trials