NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Joint Responsibilities
D. Joint Responsibilities (Key Components of the NCTN Program and NCI/DCTD)
1. General Study Development and Conduct
Because of the significant resource, regulatory, and general administrative issues involved in NCTN key
component activities and to ensure required compliance with other federal regulations and federal
agencies, the NCTN Network Groups and other key components of the NCTN should collaborate closely
with NCI/DCTD staff. This collaboration should occur early on in the development of phase 3 trials well as in
the development of other trials, general research strategies, and new initiatives. In particular, when new
avenues of cancer therapy involving investigational drugs are pursued, the trial should be designed such
that the clinical information obtained should be acceptable to the FDA for inclusion in a potential licensing
application. Therefore, the NCI/DCTD staff and the Network Group should work collaboratively to develop
protocols meeting that standard. All parties (Network Groups, NCI/DCTD staff, and company collaborators
should be involved in any conference calls and/or meeting involving the FDA during the development and
conduct of any approved NCTN trial with licensing potential, regardless of whether the study is being
conducted under CTEP IND or a Network Group IND in order to ensure that all sponsors are involved in
discussion regarding the trial.
Both the Network Groups and NCI/DCTD share the responsibility to ensure that study proposals are
reviewed/evaluated, protocols developed, and trials activated in a timely manner per the timelines
established and approved by the Operational Efficiency Working Group (OEWG), including target and
absolute deadlines for opening trials to patient enrollment. A description of the OEWG process,
requirements, and required timelines are available at: http://ctep.cancer.gov/SpotlightOn/OEWG.htm.
Both the Network Groups and NCI/DCTD also share the responsibility to collaborate on initiatives to
promote accrual to NCTN trials.
2. Data and Safety Monitoring Boards (Data Monitoring Committees)
The appropriate conduct of Network Group Data and Safety and Monitoring Boards (DSMBs), sometimes
called Data Monitoring Committees (DMCs), is a collaborative responsibility of the Network Group
(Operations Center and associated Statistics and Data Management Center) and NCI/DCTD staff.
Information on the CTEP policy for DSMBs/DMCs is available in Part 4 – Appendices – Section VIII of these
Guidelines. The Network Group’s Data and Safety Monitoring Policy must be submitted to and approved by
the Lead NCTN Program Director. All DSMB/DMC members, including the DSMB/DMC Chair, must be
approved by the Lead NCTN Program Director prior to their inclusion in DSMB/DMC meetings. Any changes
to the Network Group DMSB/DMC policy and/or membership must be reviewed and approved by the Lead
NCTN Program Director prior to implementation. The Lead NCTN Program Director also names the
NCI/DCTD staff who represent NCI/DCTD as non-voting members on the Network Group’s DSMB/DMC. If
the Network Group DSMB/DMC includes oversight of studies funded by the Division of Cancer Prevention,
all changes in membership and policy are also reviewed by the appropriate staff in DCP as applicable and
DCP also names the non-voting NCI/DCP staff person to represent the Division on the Network Group
DSMB/DMC.
3. Development of Collaborative Trials and International Trials
The Clinical Investigations Branch staff at CTEP work with the NCTN Network Groups to facilitate
international participation in trials when appropriate. When institutions outside the U.S. are members of a
U.S. Network Group and wish to participate in a U.S Group Trial, the institution and its investigators must
meet ALL the same Network Group membership requirements as U.S. institutional members and their
associated investigators, including being audited by the Network Group per CTMB guidelines for
international Participating Sites, filing FDA 1572 Forms, etc. However, when trials call for collaboration with
a separate international clinical trial organization for its participation in a U.S. Network Group trial, there
are varying degrees of logistical and regulatory complexity involved, depending on a number of factors. In
these cases, it is critical that proposals for large-scale international trials be discussed with CTEP/CIB staff in
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