Notice Number: NOT-OD-17-121

Key Dates
Release Date: October 6, 2017 - RESCINDED

Issued by
National Institutes of Health (NIH)

Purpose

This notice informs the community of additional review criteria that NIH will apply to individual career development (K) award applications submitted to due dates on or after January 25, 2018.

Important Note: Review criteria will differ for individual mentored and independent K award applications, and for K award applications where the PD/PI will lead an independent clinical trial compared with individual K award applications where the PD/PI will undertake clinical trials research experience under the guidance of the mentor or co-mentor.

Note that these additional questions will not be used for the evaluation of institutional K12 or KL2 applications.

Background

NIH is utilizing a multi-faceted approach to strengthen policies across the life cycle of a clinical trial, from development of the funding opportunity announcement (FOA), to the information collected in a grant application or contract proposal, to peer review of the application/proposal, and through to monitoring of the award. These actions include the implementation of new and more rigorous review criteria for evaluating clinical trial applications. Addressing these challenges will ensure the highest likelihood of translating research results into knowledge that will improve human health.

Implementation

The review criteria questions below will be effective for the evaluation of individual career development award (K) applications that involve independent clinical trials led by the PD/PI of the K award application or K award applications where the PD/PI will undertake clinical trials research experience under the guidance of the mentor or co-mentor, and are submitted for funding consideration for due dates on or after January 25, 2018. The questions below will be added to the existing review questions (see https://grants.nih.gov/grants/peer/critiques/k.htm). Some Program Announcements and Requests for Applications may include additional, FOA-specific questions.

Criteria

In addition, for applications involving clinical trials:

The reviewers will consider that the clinical trial may include study design, methods, and intervention that are not by themselves innovative, but address important questions or unmet needs. Reviewers should also consider the scope of the clinical trial relative to the available resources, including the
possibility that research support provided through K awards may be sufficient to support only small feasibility studies.

Scored Review Criteria

The following questions are in addition to the standard individual K award review questions:

Candidate

• Does the candidate have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?

Career Development Plan/Career Goals and Objectives

• No additional questions.

Research Plan

• If proposed, will the clinical trial experience contribute to the research project and/or the applicant’s research career development?
• Are the scientific rationale and need for a clinical trial, feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
• If proposing a small feasibility study, is the study warranted and will it contribute to planning and preliminary data needed for design of future larger scale clinical trials?
• Is the clinical trial or ancillary study necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of future clinical trial?
• Is the study design justified and relevant to the clinical, biological, and statistical hypothesis(es) being tested?
• Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?
• Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions?

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

• If the applicant is proposing to gain experience in a clinical trial as part of his or her research career development, is there evidence of the appropriate expertise, experience, and ability on the part of the mentor(s) to guide the applicant during participation in the clinical trial?
• Does the mentor or mentoring team have the expertise, experience, and ability to guide the applicant in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the timelines?

Environment & Institutional Commitment to the Candidate

• Are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
• Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate?
• If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

Additional Review Criteria

Study Timeline for Clinical Trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Inquiries

Please direct all inquiries to:

Division of Biomedical Research Workforce
Office of Extramural Programs
Office of Extramural Research
Email: [email protected]