NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
timelines required under the Operational Efficiency Working Group recommendations as
referenced in the Investigator Handbook and available at:
http://ctep.cancer.gov/SpotlightOn/OEWG.htm. Network Group SOPs should include time-lines
for the development of LOIs and Concepts from initial submission of the study idea to NCI
through study activation. The SOPs should also include mechanisms for monitoring the
performance of the Network Group Operations Center and Network Group committees and
investigators in adhering to these time-lines, as well as corrective action plans outlining steps to
be taken when these time-lines are not met. Data concerning a Network Group’s performance
in meeting time-lines for study/protocol development should be provided in its Annual Progress
Report.
In general, study proposals for treatment or advanced imaging clinical trials are evaluated as
either Letters of Intent (LOI) or Concepts depending on the whether the proposal is
reviewed/evaluated by the NCI/DCTD Cancer Therapy Evaluation Program (CTEP) Protocol
Review Committee (PRC) or by an NCI Scientific Steering Committee (i.e., disease-specific or
clinical imaging Steering Committees) and protocols are reviewed as briefly described in Part 1 –
Section IV.D.3 of these Guidelines. The Operations Center is responsible for communicating the
results of the NCI/DCTD review/evaluation process, including NCI Scientific Steering Committee
decisions, to relevant Network Group committees and Network Group members.
In addition, correlative science studies embedded in NCTN clinical trials as well as requests for
use of biospecimens collected in conjunction with an NCTN trial that were “banked” must
undergo review and approval as outlined in Part 1. Section IV.C.3 of these Guidelines, especially
sub-section 3.1. This review policy applies even if the collection or storage of specimens was
funded from sources outside the NCTN Program as the NCTN clinical trials was supported by the
NCI/DCTD under these Terms and Conditions of Award which requires review under a process
approved by NCI/DCTD unless a specific exemption to the review policy is granted by NCI/DCTD.
1.3.3 Conduct of Clinical Trials
Specific regulations regarding conduct of NCTN trials include the following:
� NCI/DCTD Approval Prior to Trial Activation and Approval of Protocol Amendments: Since
public funds are used to support Network Group studies sponsored under the NCTN
Program Cooperative Agreement, no Network Group study using funds supplied under the
Cooperative Agreement can be opened without prior approval from the NCI/DCTD as
communicated in approval letters sent to the Network Group Chair directly from the CTEP
Protocol and Information Office (PIO). The Network Group also is not allowed to expend
any NCI funds under this Cooperative Agreement to support any study disapproved by the
NCI/DCTD. In addition, all protocol amendments must be submitted to CTEP’s PIO and be
approved by NCI/DCTD prior to implementation. Depending on the nature of the
amendment, the trial may or may not be put on hold to further accrual and/or treatment
until the amendment is approved.
The required evaluation and review process for NCTN trials is explained in Part 1: Section
IV.D.3. of these Guidelines with additional information in the DCTD Investigator Handbook
(A Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by
CTEP, DCTD, NCI) available at:
http://ctep.cancer.gov/investigatorResources/investigators_handbook.htm.
� INDs for Studies: In addition, Network Group phase 3 trials (including phase 2/3 studies)
using funds supplied under this Cooperative Agreement cannot be conducted under a
company IND; all phase 3 IND trials supported, in whole or in part, under this Cooperative
Agreement must be conducted under a Network Group IND or a DCTD IND (e.g., CTEP or CIP
IND). This also applies to phase 3 trials requiring an IDE. Phase 1 and phase 2 trials may be
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