NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.6 – Review Criteria
Canadian Collaborating Clinical Trials Network
indicate it will present and publish results from clinical trials it leads in a timely
manner?
Senior Group Leadership for Clinical Trials Development: How complete and
comprehensive is the expertise of the applicant's investigators overall and the Senior
Leadership of the applicant's organization (operations, statistics, and data
management)? 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? 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 Canadian Collaborating
Clinical Trials Network?
Are the scope and authority of the senior leadership, Director of Operations position,
and Executive/Advisory Committee for the organization clearly and appropriately
addressed? Are the background and expertise of the proposed Director of Operations
appropriate to oversee the operational management of the Group? Is the Director of
Operations identified as key personnel in the application? Are the policies and
procedures for institution/site membership (included in the Constitution and By-laws
of the proposed Canadian Collaborating Clinical Trials Network) clear and appropriate
for the NCTN Program?
If the application includes multiple PD(s)/PI(s), are the proposed leadership
governance, organizational structure, and decision-making processes and interactions
among the members of the leadership team for the application optimal for achieving
the goals of the application and the overall NCTN Program?
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 diseases appropriate to the stated
research goals? 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
underserved patient populations, financial management)?
Training and Investigator Leadership Mentoring/Training: Does the applicant have
appropriate training programs for study chairs and Clinical Research Associates? Does
the applicant have a mentorship/training program for new and junior investigators
that provides opportunities for leadership of clinical trials (e.g., developing concepts
for trial proposals, serving as study chairs for trials, participating in scientific
committees in support or leadership roles, participating in other clinical trial activities)
at appropriate levels as well as the potential to provide opportunities to these
investigators to participate in the future in NCTN activities or initiatives?
Accrual Potential: Given its past track record of accrual, does the applicant have the
potential to provide accrual to clinical trials conducted across the NCTN as a whole,
especially in the applicant's stated areas/diseases of research interest, given the
patient population of Canada? Does the applicant have the potential to contribute to
accrual of Canadian minority and underserved patient populations to trials? Do the
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