NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.2 – Review Criteria
Network Group SDMC
If the application includes multiple PD(s)/PI(s) (which is encouraged), are the
proposed leadership governance, organizational structure, and decision-making
processes and interactions among the members of the leadership team for providing
statistical expertise for effective scientific design and conduct of multi-disciplinary,
multi-institutions in a range of cancer types and special populations with specific
scientific strategy and goals?
How well has the proposed Network Group Statistical and Data Management Center
(SDMC) demonstrated its ability and track record to provide appropriately designed,
robust, statistical analysis plans for early phase and especially late phase, definitive,
multi-institutional clinical trials in oncology, including integral and integrated
biomarker/correlative science studies? Does it appear that the applicant has the
necessary expertise and experience to incorporate new molecular and imaging
biomarkers into the overall evaluation of NCTN trials appropriately? Are the
procedures for sample size estimation, end point selection and monitoring plans
adequately described and justified? Are analytical techniques, procedures, and
policies adequate, appropriate, and consistent with accepted standards? Is there
evidence that past publications by the SDMC demonstrate thorough and
state-of-the-art methodology, awareness of problems of multiple analyses, and
sufficient independence and lack of bias of statistical collaborators? Does the sample
of trial reports from the Report of Studies indicate appropriate and timely data and
study analyses?
Collaborative Research: Does the applicant have a track record for collaborations
with other clinical trial organizations and other NCI-sponsored programs and
investigators (e.g., SPOREs, NCI Cancer Centers, R01/P01 investigators) on statistical
design and analysis on clinical trials and translational science studies that
demonstrates its potential for collaboration within the NCTN Program? Has the
applicant demonstrated that it has the capacity to provide statistical design and
analysis (as well as data management) for clinical trials that come from investigators
outside its associated Network Group Operations Center? Does the applicant
demonstrate the ability to perform independent statistical research?
Collective Management Activities: Does the applicant have a track record that
demonstrates that the members of its scientific and technical staff can participate in
or can actively contribute to NCI clinical trial activities (e.g., disease-specific and
modality-specific Scientific Steering Committees and related task forces or working
Groups, Clinical Trials Planning Committees for meetings supported by the NCI
disease-specific Steering Committees, participation in other NCI programs and
initiatives related to clinical research)? Do SDMC members demonstrate the potential
to participate as members of the NCI Central IRBs? Does the applicant have a robust
plan to ensure that clinical data is provided in a timely and user-friendly format for
public access to data from clinical trials and for studies approved for use of
biospecimens and data as an indication of the applicant’s potential to provide these
services efficiently for the NCTN Program? How well does the applicant demonstrate
its potential to implement new initiatives and new standards for clinical trial conduct
and data management in a timely fashion?
2.2.4 Scored Review Criteria – Criterion B. Data Management Program
(Note: The entire Criterion B will receive one individual score; the subcategories and
aspects listed will be assessed but not scored separately).
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