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NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 2: Submission of New/Competing Application Section III.B.2.4 – Review Criteria<br />

<strong>Network</strong> Lead Academic Participating Site<br />

2.4 Lead Academic Participating Site Review Criteria<br />

Only the review criteria described below (and the Additional Review Criteria – Overall listed<br />

in Part 2 – Section III.B.3.) will be considered in the review process. As part of the NIH<br />

mission, all applications submitted to the NIH in support of biomedical and behavioral<br />

research are evaluated for scientific and technical merit through the NIH peer review<br />

system.<br />

2.4.1 Overall Impact - Overall<br />

Reviewers will provide an overall impact/priority score to reflect their assessment of<br />

the likelihood for the proposed <strong>Network</strong> Lead Academic Participating Site to exert a<br />

sustained, powerful influence on the research field(s) involved, in consideration of the<br />

following review criteria and additional review criteria (as applicable for the proposed<br />

<strong>Network</strong> Lead Academic Participating Site).<br />

2.4.2 Scored Review Criteria – Overall<br />

Reviewers will consider each of the review criteria below in the determination of<br />

scientific merit, and give a separate score for each. An application does not need to<br />

be strong in all categories to be judged likely to have major scientific impact. For<br />

example, a proposed <strong>Network</strong> Lead Academic Participating Site that by its nature is<br />

not innovative may be essential to advance a field.<br />

Significance<br />

Does the proposed <strong>Network</strong> Lead Academic Participating Site help address an<br />

important problem or a critical barrier to progress in the field? If the aims of the<br />

proposed <strong>Network</strong> Lead Academic Participating Site are achieved, how will scientific<br />

knowledge, technical capability, and/or clinical practice be improved? How will<br />

successful completion of the aims change the concepts, methods, technologies,<br />

treatments, services, or preventative interventions that drive this field?<br />

Investigator(s)<br />

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the proposed<br />

<strong>Network</strong> Lead Academic Participating Site as well as its plans for collaborations and<br />

collective management? If Early Stage Investigators or New Investigators, or in the<br />

early stages of independent careers, do they have appropriate experience and<br />

training? If established, have they demonstrated an ongoing record of<br />

accomplishments that have advanced their field(s)? Given that <strong>NCTN</strong> research<br />

projects/trials are collaborative, and regardless of whether the applicants choose to<br />

use the multi-PD/PI option, do the investigators have complementary and integrated<br />

expertise; are their leadership approach, governance and organizational structure<br />

appropriate for the clinical research that the proposed <strong>Network</strong> Lead Academic<br />

Participating Site is expected to help conduct and manage?<br />

Innovation<br />

Does the application challenge and seek to shift current research or clinical practice<br />

paradigms by utilizing novel theoretical concepts, approaches or methodologies,<br />

instrumentation, or interventions? Are the concepts, approaches or methodologies,<br />

instrumentation, or interventions novel to one field of research or novel in a broad<br />

sense? Is a refinement, improvement, or new application of theoretical concepts,<br />

approaches or methodologies, instrumentation, or interventions proposed?<br />

Page 168 of 241

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