NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Appeals Process
E. Appeals Process for Decisions Regarding Study Proposals & Types of Studies Performed by NCTN Program
This appeal process is only for disagreements related to scientific merit decisions made on study proposals for
the NCTN Program or the programmatic definition of study types supported under the NCTN Program.
1. Decisions on Study Proposals
The appeals process for decisions related to study proposals supported under the NCTN Program (including
both intervention and non-intervention studies) is described below.
� For NCTN phase 3 and phase 2 Concepts evaluated by NCI Scientific Steering Committees (or the CTEP
Protocol Review Committee for disease areas without an NCI Scientific Steering Committee or in lieu of
an NCI Scientific Steering Committee because of scheduling/workload issues) that are not approved for
development based on scientific merit, the Network Group Operations Center may “appeal” the
decision to the Director, Division of Cancer Treatment and Diagnosis, if the Network Group Operations
Center believes that there were factual errors in the evaluation that led to the disapproval. If the
Director agrees with the appeal request by the Network Group Operations Center, the Director will
direct the appropriate NCI disease-specific Steering Committee to re-evaluate the study proposal. The
result of the re-evaluation will be considered final.
� For NCTN phase 1 and phase 2 Letter of Intent (LOI) proposals evaluated by NCT/CTEP’s Protocol
Review Committee for trials proposals that would be conducted under CTEP IND, the Network Group
Operations Center may appeal an LOI not approved for development based on scientific merit by
requesting that the Investigational Drug Steering Committee (IDSC) review the LOI. The result of the
review of the LOI by the IDSC will be considered final.
� For NCTN phase 1 and phase 2 LOIs reviewed by NCI/CTEP’s Protocol Review Committee for trials
proposals that would NOT be conducted under CTEP IND, the Network Group Operations Center may
appeal an LOI not approved for development based on scientific merit to the Director, Division of
Cancer Treatment and Diagnosis, if the Network Group Operations Center believes that there were
factual errors in the review that led to the disapproval. If the Director agrees with the appeal by the
Center, the Director will direct CTEP’s Protocol Review Committee to re-evaluate the study proposal.
The result of the re-evaluation will be considered final.
� For NCTN non-intervention studies (i.e., correlative science studies that request use of biospecimens
collected in association with an NCTN trial) reviewed by NCI/CTEP’s Protocol Review Committee or
evaluated by an NCI/DCTD-approved NCTN Correlative Science Committee, the Network Group
Operations Center may appeal a study proposal not approved for development based on scientific
merit to the Director, Division of Cancer Treatment and Diagnosis, if the Network Group Operations
Center believes that there were factual errors in the review that led to the disapproval. If the Director
agrees with the appeal by the Center, the Director will direct CTEP’s Protocol Review Committee or the
NCI/DCTD-approved NCTN Correlative Science Committee to re-evaluate the study proposal. The result
of the re-evaluation will be considered final.
Any approval of a Concept, LOI, or non-intervention study proposal, even after appeal, is subject to
feasibility/resource considerations as determined by NCI/DCTD.
2. Decisions on Types of Studies Funded Under the NCTN Program
The Associate Director, NCI/CTEP makes decisions regarding any questions regarding the interpretation of
the types of studies funded under the NCTN Program in consultation with the Chief of the Clinical
Investigations Branch and Lead NCTN Program Director. The Network Group Operations Center may appeal
this decision to the Director, Division of Cancer Treatment and Diagnosis for a particular study, if the
Network Group Operations Center believes the type of study is within the scope of the NCTN Program as
described in these Guidelines. If the Director agrees with the appeal by the Network Group Operations
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