NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section III – General Management & Network Operating/Funding Principles
charitable funds, and/or specific administrative supplements to the Cooperative Agreements under the
NCTN Program in special situations.
2. Funding for Data Collection/Management & Biospecimen Collection on “Per Case” Basis
NCI funding for institutions participating in all NCTN trials to cover the costs related to data
collection/management and biospecimen collection (also called “per case management funding”)
associated with enrolled patients is provided in 2 ways:
1) grant funding from NCI to Lead Academic Participating Sites, CCOPs, and MB-CCOPs or
(2) grant funding from NCI to Network Groups which then contract with member institutions/sites
via purchase service or subcontract agreements on a “per-case” basis.
Any threshold level of accrual used to determine budgets/funding is based on accrual to all NCTN trials
regardless of which Network Group Operations Center is credited with the accrual by the enrolling site.
These threshold levels are also based on the number of patients who are enrolled on intervention
treatment or advanced imaging arms of clinical trials only (i.e., threshold levels are not based on number of
patients who undergo screening when it is part of the clinical trial or for whom biospecimens are collected).
Also, advanced imaging interventions are weighted at 50% of a treatment intervention given the more
limited intervention and follow-up required in those studies.
2.1 Network Lead Academic Participating Sites Funding
NCI/DCTD funding given to adult Network Lead Academic Participating Sites is based on a “level-ofeffort”
as outlined in their budget application. This “level-of-effort” budget covers data
collection/management and biospecimen collection for a certain number of adult cancer patients
enrolled on an annual basis (accrual threshold) as well as other infrastructure support to the sites.
This “level-of-effort” is based on a “per-case” algorithm utilizing the amounts estimated for “High-
Performance Per Case Management” funding as well as other funding categories as specified in Part 4:
Appendices – Section IV of these Guidelines for the portfolio of trials that the site anticipates it will
support. In addition, the Lead Academic Participating Sites may receive administrative supplements
to cover costs associated with the enrollment of additional patients above the threshold for this type
of award.
2.2 CCOPs and MB-CCOPs Funding
Funding to CCOPs and MB-CCOPs for enrollment of patients to NCTN trials is provided by the Division
of Cancer Prevention based on a similar system as the one used for the Network Academic
Participating Sites but with different thresholds for patient accrual used to estimate the level of
funding provided via their grant awards.
2.3 Pediatric Network Group Member Institutions/Sites Funding
NCI/DCTD funding given to the pediatric Network Group Operations Center for its member
institutions/sites, which are not CCOPs or MB-CCOPs, is provided to these sites through purchase
service agreements or subcontracts using a special algorithm for either “Intervention Per Case
Management” or “High-Performance Per Case Management” funding to a site as well as other funding
“Per Case” categories as specified in Part 4: Appendices – Section IV. The “High-Performance Per Case
Management” funding is based on a different threshold for patient accrual than that used for adult
patient accrual given the smaller pediatric patient population and more limited sources of private
funding available for pediatric trials. In addition, pediatric sites may also receive additional
infrastructure support based on the overall level of patient accrual at their site since they are not
eligible for the adult Network Academic Participating Sites awards which provide this type of support
to high-performance sites engaged in NCTN trials that enroll adult cancer patients on NCTN trials.
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