NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.1 – Review Criteria
Network Group Operations Center
conducted by government or private sector, provision of important toxicity or dosing
information)? Does the applicant team have effective mechanisms for promoting timely
presentation and publications of the results of clinical trials and associated studies?
Investigator(s)
Senior Group Leadership for Clinical Trials Development: How well can the PD(s)/PI(s)
and the entire team of investigators assembled by the applicant provide scientific
leadership for state-of-the-art early and late phase clinical trials in adults and/or
children with cancer? Will these investigators be able to work as a cohesive research
team to efficiently and expeditiously develop and conduct NCTN clinical trials? Does the
applicant have appropriate and clearly defined succession and transition plans for the
senior leadership of the proposed Network Group Operations Center? Does the
applicant have reasonable and appropriate limitations on terms for senior leadership
that encourage rotation of leadership responsibilities?
Scientific Research Committee Leadership: Do the research experience and
qualifications of the leadership of the applicant's Scientific Research Committees
provide multi-disciplinary representation (e.g., medical oncology, radiation oncology,
imaging, surgery, pathology, translational science, patient advocacy) across a broad
range of oncology diseases appropriate to the stated research goals? Does the
leadership of the scientific committees have a track record of successful multiinstitutional
early phase and especially late phase clinical trials research as evidenced by
publications? Do the Scientific Research Committees provide leadership opportunities
for a broad range of investigators and are there reasonable and appropriate limits on
terms for senior leadership of the Scientific Research Committees that encourage
rotation of leadership responsibilities and provide continuity and stability in the
Committees?
Administrative Committee Leadership: Are the experience and qualifications of the
leadership of the applicant's Administrative Committees appropriate for development
and oversight of the administrative management categories needed for conducting both
early phase and especially late phase, multi-institutional, clinical trials (e.g., support
functions for trials including involvement of patient advocates, support programs for
enrollment of members of underserved patient populations, financial management)?
Innovation
Innovation in Early and Late Phase Clinical Trials: Within the confines of the ethical
constraints applicable to early and late phase clinical trials for oncology patients, does
the applicant propose novel or improved ways and/or methods to enhance or better
serve its overall research strategy and the goals of developing and implementing multidisciplinary,
multi-institutional trails in a range of cancer types and special populations
with specific scientific strategy and goals?
Approach
Approach to Clinical Trial Development: Are the overall strategy, methodology, and
analyses well-reasoned and appropriate to accomplish the specific clinical aims of the
applicant? Are potential problems, alternative strategies, and benchmarks for success
presented for specific clinical trials?
Environment
Leveraging Resources to Support Research: How successful are the members of the
applicant team in obtaining other funding (from NCI, other governmental agencies,
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