NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
� Early Trial Closure: The Network Group Operations Center must establish policies and
procedures for early closure of studies in conjunction with the associated SDMC. The
Operations Center should explicitly describes the policies in place for phase 1 and phase 2
studies as well as those used for phase 3 studies. Statistical guidelines for early closure
should be presented as explicitly as possible in the protocol in order to facilitate decisions
regarding early closure. NCI/DCTD have approved early stopping guidelines for slowlyaccruing
phase 3 studies for the NCTN Program, including phase 2/3 trials (see Part 4 –
Appendices – Section I.F). If accrual is behind expectations for a specific trial, the Network
Group should involve the appropriate NCI/DCTD staff in discussions about possible ways to
enhance accrual in order to avoid study closure.
Procedures regarding notification of CTEP about early study closure are outlined below and
should be incorporated into the Group’s policy for study closure. These procedures also
apply to major modifications to study design and to suspension of study accrual and/or
treatment (e.g., suspension due to patient safety issues) for any NCTN trial, regardless of
whether it is under CTEP IND or not.
For any Network Group phase 1 or phase 2 trial for which CTEP is the IND sponsor of one
or more study agents or is providing agent(s), the Network Group must notify and receive
approval from the appropriate CTEP staff (i.e., Investigational Drug Branch physician agent
liaison and Clinical Investigations Branch physician disease liaison) before initiating study
closure. In the rare case that CTEP is supplying/distributing a non-CTEP IND/commercial
agent for a phase 1 or phase 2 study, the Group must inform the appropriate CTEP staff (i.e.,
Clinical Investigation Branch staff member responsible for the disease portfolio) of study
closure prior to public notice.
For all other phase 1 or phase 2 studies, the Group must notify the appropriate CTEP staff
(i.e., the Clinical Investigations Branch physician disease liaison and the Lead NCTN Program
Director) prior to closure of the study in cases where closure (or study modification or
suspension) is due to adverse events or other patient safety issues since this information
may affect safety in other NCTN or CTEP-sponsored trials as well as in the study which is
being closed.
For all Network Group phase 3 studies, the Network Group’s DSMB should have reviewed
the study and recommended study closure and the Network Group Chair should have
concurred with this decision, with the exception of phase 3 studies being closed per the
NCTN early stopping guidelines for slowly-accruing phase 3 studies. Although CTEP approval
of early closure of a phase 3 study is not required when closure is recommended and
approved by both the DSMB and Network Group Chair, the Network Group must inform
and discuss closure of the study with the Lead NCTN Program Director or his/her designee
before closure of the study and before disclosure to Network Group members, the PI(s)
and investigators, the company sponsor (if applicable), the study patients, and the public
so that both NCI/CTEP and the Group will be prepared to address public inquiries and
other potential issues.
For phase 3 studies conducted under a CTEP IND or for which CTEP supplies/distributes one
or more of the study agents, this notification also helps CTEP to begin to address issues
related to the supply/distribution of the agent, the company sponsor, and regulatory issues,
in addition to being able to coordinate public dissemination of the information and address
public inquiries about the trial. For additional information related to Network Group
DSMBs, see Part 4 – Appendices – Section VIII.
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