NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Lead Academic Sites
4. Specific Awardee Rights & Responsibilities – Network Lead Academic Participating Sites
Throughout these Terms and Conditions of Award, “Network Lead Academic Participating Site” refers to the
organizational structure which is composed of the key personnel (including the scientific and administrative
leaders at the Site) responsible for implementing NCTN clinical trials and collaborating on research goals of
the NCTN Program with the Network Group Operations Centers and associated Network Group Statistics
and Data Management Centers. In addition, throughout these Terms and Conditions of Award, “Network
Lead Academic Participating Site,” refers to the main academic institution/site as well as any affiliate site(s)
included in the award if the Network Lead Academic Participating Site provides complete management
services for the affiliate site(s) related to enrolling patients on NCTN clinical trials.
Definition of a Network Lead Academic Participating Site: An academic institution/organization for the
purposes of this award is 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 budgeting/funding with “high-performance intervention per case
management” funding as described in Part 2 - Section II.E.1 in the of these Guidelines. These other
organizations may be considered “affiliates” of the Network Lead Academic Participating Site and be
included in the award under that designation (i.e., “affiliate”), if the Network Lead Academic Participating
Site will provide complete management services for the affiliate site related to enrollment of patients on
NCTN trials.
An academic institution/organization for the purposes of this award cannot be a Community Clinical
Oncology Program Group (CCOPs) or Minority-based Clinical Oncology Program Group (MB-CCOPs) funded
by the NCI Division of Cancer Prevention (DCP).
Annual Accrual Threshold to Maintain “High-Performance Intervention Per Case Management” Funding: It
is anticipated that a Network Lead Academic Participating Site will maintain patient enrollment to
therapeutic and/or advanced imaging interventions (not pilot studies) for all NCTN trials at a threshold rate
of at least 55 to 70 patients per year or more; however, each Lead Academic Participating Site awardee will
have a specific annual accrual threshold that is used to calculate its budget base. Since advanced imaging
trials generally do not have as intensive an intervention or as long a follow-up period as therapeutic trials,
this annual threshold rate for the Lead Academic Participating Site is calculated based on the number of
patients enrolled on therapeutic intervention arms (i.e., patients undergoing screening only are not
included) plus ½ the number of patients enrolled on advanced imaging trials. For example, if a Network
Lead Academic Participating Site’s budget is based on an annual accrual threshold of 80 patients across the
Network and the academic site enrolls 70 patients to therapeutic intervention arms of clinical trials and 20
patients to advanced imaging trials in the first year of its award, it would have had 80 patient accruals that
year and thus would have met its annual accrual threshold (70 therapeutic accruals + 20÷2 advanced
imaging accruals = 70+10 = 80 patient accruals). If a Network Lead Academic Sites does not maintain this
annual rate during the first 3 years of the award, funding for years 4 and 5 of the award may be adjusted
with a decrease in the amount of “high-performance intervention per case management” funding or
replacement of this funding with the lower “basic intervention per case management” funding for
therapeutic trials. Note: Accruals from affiliates included in the Network Lead Academic Participating Sites
award do not count toward the annual threshold accrual goal for the academic center.
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