NCI National Clinical Trials Network (NCTN) Program Guidelines

Part 4: Appendices – VII. NCTN Program Data & Safety Monitoring Policy
for Phase 3 & Randomized Phase 2 Trials
written confirmation by the Chief, CIB prior to their official appointment and participation in DSMB/DMC
activities. The committee will include physicians and statisticians from within and outside the Network
Group selected based on their experience, reputation for objectivity, absence of conflicts of interest (or the
appearance of same), and knowledge of good clinical trial methodology. The committee must include a
consumer representative and a voting statistician from outside the group. A NCI/DCTD physician and a
NCI/DCTD Biometric Research Branch (BRB) statistician, as designated by the Chief, CIB will be non-voting
members and must be free to attend all sessions of the DSMB/DMC including closed and executive sessions.
The designated Network Group Statistician, or his or her designee, will also be a non-voting member of the
DSMB/DMC.
For those Network Groups which are funded as CCOP Research Bases, a designee named by the Division of
Cancer Prevention (DCP) Community Oncology and Preventive Trials Research Group (COPTRG) program
director will be a non-voting member and must be free to attend all sessions.
The DSMB/DMC may be constituted fully by individuals who are not members of the Network Groups.
Alternatively, the DSMB/DMC may have voting members who are also members of the Network Group;
however, the majority of the voting DSMB/DMC members cannot be affiliated with the Network Group and
voting quorums for a DSMB/DMC meeting require that the majority of voting members not belong to the
Network Group. Network Group members who are members of the DSMB/DMC must see themselves as
primarily representing patient interests and not the interests of the Network Group or designated Network
Group Chair. Members of the study team or the leadership of the disease committee or scientific research
committees of the Network Group (e.g., chair or vice-chair of the disease committee) conducting a study
will recuse themselves from all DSMB/DMC discussions concerning that study and will not receive
DSMB/DMC reports concerning that study. Additionally, the study statistician will not be a voting member
of the DSMB/DMC for his/her trial. The designated Network Group Chair, Principal Investigator(s)/Program
Director(s) on the Network Group Operations Center grant using the multiple Principal Investigator option,
or any member of the executive leadership of the Network Group (including vice-chairs and executive
officers, but not disease-committee chairs or members of Network Group executive committees, as long as
they are not also vice-chairs or executive officers) cannot attend closed or executive sessions of the
DSMB/DMC. In addition, the designated Network Group Chair, Principal Investigator(s)/Program Director(s)
on the Network Group Operations Center grant using the multiple Principal Investigator option, or any
member of the executive leadership of a Network Group, cannot be a member of the DSMB/DMC of a
different Network Group.
The size of the DSMB/DMC should be limited, and it is unlikely that more than 10 people would be required
to constitute a DSMB/DMC.
Meetings
DSMB/DMC meetings will be held at least once every six months. Each randomized clinical trial should have
specified interim analysis times, although the DSMB/DMC should be apprised at each meeting of the status
of all trials for which it is responsible, e.g., accrual, toxicity concerns, and the next formal monitoring date as
specified in the protocol. DSMB/DMC meetings should be in person (rather than by telephone) generally,
and especially when new members of the DSMB/DMC have been appointed. At a minimum, DSMB/DMC
meetings must be held in person every 18 months, and any possible exceptions to this must be approved by
NCI/DCTD.
It is recommended that a written report outlining the current status of each trial to be monitored be sent to
the DSMB/DMC members by the study statistician at least three weeks prior to the DSMB/DMC meeting.
The Study Chair may prepare a report addressing specific toxicity concerns or other concerns about the
conduct of the study. The statistician's report may contain recommendations on whether to close the
study, whether to report the results, whether to continue accrual or follow-up and whether DSMB/DMC
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