NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – NCI/DCTD Responsibilities
may forward these for evaluation/prioritization by the appropriate NCI Scientific Steering
Committee. Network Groups submitting these types of trial proposals, especially proposals with
sample sizes of 90 or more patients, are encouraged to use the Concept submission form in case
the proposal is forwarded to an NCI Scientific Steering Committee. For pediatric studies (including
studies for adolescents and young adults submitted from the pediatric Network Group), it is
anticipated that all pediatric phase 2 studies (regardless of the study sample size) and pediatric
feasibility and pilot studies of 100 patients or more will be forwarded by CTEP to the appropriate
NCI Scientific Steering Committee given the limited pediatric patient population.
� If an appropriate NCI Scientific Steering Committee (SSC) does not exist for a disease area or is
not available for evaluation of a trial proposal submitted by a Network Group Operations Center
for other reasons (e.g., significant workload or scheduling issues), the trial proposal will be
reviewed by CTEP’s PRC with ad hoc extramural scientific reviewers, as needed.
� BIQSFP applications that are related to clinical treatment or advanced imaging trial proposals
submitted by the Network Group Operation Centers are initially evaluated by the appropriate NCI
SSC (or by CTEP with ad hoc extramural scientific reviewers) with the reviewer recommendations
forwarded to the NCI Clinical and Translational Research Operations Committee (CTROC) for a final
decision on the BIQSFP application and budget.
� Correlative science studies embedded in NCTN clinical trial studies at the time of initial proposal
submission should be appropriately designed as integral and/or integrated studies with robust
statistical designs and analysis plans that address specific and important scientific hypotheses.
Exploratory studies without a specific hypothesis and robust statistical analysis plan will not be
approved. Although optional collection of biospecimens without an approved research plan may
be approved for a trial (e.g., adjuvant study), use of the specimen must be approved by CTEP and
must be based on studies with specific hypotheses and statistical analysis plans (i.e., biospecimens
cannot be “reserved” for future unspecified research without a subsequent study proposal being
reviewed and approved).
� Correlative science studies requesting use of biospecimens from any NCTN clinical trial that
has not yet reported out primary results is evaluated by CTEP’s PRC (usually as an amendment
during the course of the conduct of the study). At CTEP’s discretion, depending on the timing of
the request, the correlative science study may be sent for evaluation to an NCI/DCTD-approved
NCTN Correlative Science Committee.
All correlative science studies requesting use of biospecimens from any NCTN clinical trial that
has reported out primary results (i.e., request for use of “banked” biospecimens) is reviewed by
CTEP’s PRC or sent by CTEP for evaluation to an NCI/DCTD-approved NCTN Correlative Science
Committee.
It is anticipated that all requests for use of “banked” biospecimens collected in associated with any
NCTN clinical trial (regardless of funding source) will be submitted to a central NCI/DCTD “Triage
Committee” in order to assess the appropriateness of the request for use of these scarce resources
that are linked to annotated clinical trial data, including outcome data, as well as determining with
the Network Group based on its biospecimen inventory and the status of the clinical trial data,
whether the request could be addressed. If the central NCI/DCTD “Triage Committee” determines
that the request is appropriate, the request will then be sent to NCI/CTEP’s Protocol Information
Office (PIO) for evaluation via CTEP’s PRC or an NCI/DCTD-approved NCTN Correlative Science
Committee. Correlative science studies requesting use of “banked” biospecimens should be
appropriately designed with robust statistical designs and analysis plans that address specific and
important scientific hypotheses (and with the statistician named as part of the study proposal on
its title page).
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