NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section II –Budget & Research Plan
Network Lead Academic Participating Sites
E. Network Lead Academic Participating Site Application
Specific instructions are provided on the following pages for the Network Lead Academic Participating Site
application. In general, except where noted below, all applications should conform to the instructions in the PHS
398/SF424. An application must be submitted by an academic institution/organization defined as a hospital
and/or clinic program providing direct medical care to patients that is considered one integral organizational
entity under a single financial management system and governance structure. Academic centers for the
purposes of this award are distinguished from large medical centers whose primary mission is patient care. In
addition to patient care, academic centers have comprehensive medical training programs and have preclinical
laboratories that perform basic research.
Hospitals, clinics, military or VA hospitals or treatment facilities, and health care organizations that may provide
services in collaboration with the applicant institution in a network, but which are not an integral component of
the organization under a single financial management system and governance structure that comprises the
applicant institution (i.e., Network Lead Academic Participating Site consisting of an academic center and its
essential components), may not be considered part of that institution for the purposes of this award with
respect to how the budget request for the application should be estimated, as described in Part 2 - Section II.E.1
in these Guidelines.
These other organizations may, however, be considered “affiliates” of the Lead Academic Participating Site and
may be included in the application under that designation (i.e., “affiliate”), if the Lead Academic Participating
Site will provide complete management services for the affiliate site related to enrollment of patients on NCTN
trials (although the complete management services do not have to include IRB services). Affiliate(s) that meet
this description are allowed to be included in the application of the academic center for ease of administration
for the academic center (i.e., so that the NCI funding for data management of NCTN enrollments at the
affiliate(s) go to the academic center directly from the NCI, but these affiliate(s) do NOT have to be included in
the application. The accrual and other activities of the affiliate(s) are NOT part of the review criteria for the
academic center application – affiliate accrual is only included to justify the budget request of the academic
center as the goal of the academic center award is to provide funding for academic centers that have the
potential to provide significant scientific leadership and accrual to the NCTN (it is not a goal of the award to
build affiliate or regional networks). Thus, an academic center can have all its affiliates or some of its affiliates
funded outside of the application. In the circumstance that an affiliate of an academic center with a Lead
Academic Participating Site grant is not funded via the grant, the affiliate would receive its “per-case
management” funding via the Network Group it credits with the accrual per the membership funding rules of
that Network Group. If an affiliate is included in a Lead Academic Participating Site application, then that
affiliate will receive ALL NCI funding for data management associated with patient enrollment to any NCTN
trial via the grant and any budget request in the application related to the affiliate should follow the
methodology for budget preparation as described below (i.e., the affiliate cannot be an affiliate of another
institution for purposes of its NCTN program participation in treatment and advanced imaging trials).
Other applicant organizations that are not eligible to apply for the Network Lead Academic Participating Site
awards include Community Clinical Oncology Program Groups (CCOPs) and Minority-based Clinical Oncology
Program Groups (MB-CCOPs) funded by the NCI Division of Cancer Prevention (DCP).
Applications must come from academic institutions/organizations that meet the eligibility definition of a Lead
Academic Participating Site. In addition, however, all prospective formally eligible applicants must be alerted
that they will be expected to convincingly demonstrate the potential to accrue at least 55 to 70 patients per year
to treatment interventions and/or advanced imaging interventions (excluding pilot studies) on adult cancer
clinical trials. Applications that fail to do so would be unlikely to be competitive at the time of peer review.
1. Detailed Budget for the Initial Budget Period
1.1 Estimation of Total Cost Budget Request Based on Potential Accrual to NCTN Trials
The total cost budget that can be requested by the Lead Academic Participating Sites in its
application should be based on 2 components: (1) an algorithm used to estimate the cost of
the data collection/management and biospecimen collection (i.e., “per case data
management” funding associated with enrolling patients on NCTN trials for the academic
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