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Committees: Structure and Function
1.5.3.1 - Disease Site Committees
Disease site committees discuss proposals for new studies, consider their
scientific merit and feasibility, and assign priorities when necessary.
They are composed of representatives of centres participating in trials
in the various sites whose primary function is to communicate to the Group
the attitudes of their centres regarding trial proposals. In 1992 centres
with radiation facilities were asked to nominate two representatives to
their active sites to ensure radiation oncology representation.
Disease site committees meet regularly at the annual NCIC CTG meeting
of participants and, when necessary, at the Fall Meeting of Committees.
In addition, members are regularly polled regarding ideas for studies.
NCIC CTG support for disease site committee members to attend meetings
is linked to accrual.
1.5.3.2 - Trial Committees
In general, trial committee members are drawn from the disease site committees.
Trial committees have the following responsibilities: 1) to develop and
write, with the assistance of the central office, the trial protocol; 2)
to make recommendations for modifications as necessary while the trial
is in progress; 3) to participate with the central office and the Clinical
Trials Committee in decisions regarding termination of the study; and 4)
to write and submit for publication the results of the study.
In the past, trial committees have been chosen to provide broad disciplinary
and geographic representation. In 1990 the Clinical Trials Committee decided
to limit trial committee size to the study chair and a maximum of three
other investigators, including representatives of the disciplines involved.
1.5.3.3 - Clinical Trials Committee
The Clinical Trials Committee is responsible for advising the Director
on all substantial issues concerning the programme. Members are appointed
by the Director for a three-year term. This Committee reviews the proposals
for studies brought forward by the disease site committees and recommends
for or against activation. It is important to emphasize that the Clinical
Trials Committee considers all proposals for new studies and assigns priorities
to them on an individual basis. It must at times decide between new trials
in, for example, breast cancer and lung cancer. The Committee also advises
on all major policy issues: for example, authorship of publications.
1.5.3.4 - Investigational New Drug (IND) Committee
The IND Committee advises the Director of the IND Program on policy matters
and the overall direction of new drug studies, and to that extent serves
as an extension of the Clinical Trials Committee and as a standing modality
committee. Membership of the IND Committee is however determined largely
by phase I and II study participation. Members are expected to represent
the views of their centres regarding interest and feasibility in proposed
studies and serve as conduits for communication within their centres.
1.5.3.5 - Quality of Life Committee
The main purpose of the Quality of Life Committee is to advise the Group
on matters related to quality of life assessments. It exercises this function
in three ways. 1) All new phase III protocols are required to have a statement
regarding the likely impact of the treatments studied on quality of life.
The Committee is responsible for reviewing this statement and -- if it
is decided to assess this impact by collecting data on quality of life
during the study -- to advise on how best this might be done. 2) Committee
members maintain active contact with investigators in this area across
Canada and internationally, and exchange information on new developments
informally and at NCIC CTG meetings. 3) The Committee may initiate research
projects concerning the measurement of quality of life on subjects pertinent
to ongoing trials. In November 1993, the Committee nominated its members
to sit on the various site committees to ensure ongoing liaison and communication.
1.5.3.6 - Quality Assurance Committee
The overall purpose of this Committee is to advise on and supervise NCIC
CTG quality assurance/quality control programmes. Specific functions include:
1) to review the results of on-site visits and make recommendations for
improvements when problems are detected; 2) to approve measures to be used
in assessing "centre performance," set desired standards of performance
for those measures, and establish minimal acceptable criteria and reproval
mechanisms; 3) to review recommendations from modality committees on quality
control measures specific to their modalities.
1.5.3.7 - Radiation Oncology Quality Assurance
Committee
This committee was formed to oversee quality control of radiotherapy on
NCIC CTG studies.
1.5.3.8 - Clinical Research Associates Committee
The mandate of the Clinical Research Associates Committee is to improve
the quality of NCIC CTG studies of therapy in cancer and supportive care,
through:
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providing a voice for data managers in
- protocol and forms design and development, and
- disease site, modality, and other NCIC CTG committee discussions
and decisions;
-
lending impetus and direction for the implementation of training and educational
programmes for new and experienced data managers;
-
improving communication among data mangers from institutions across the
country, and between data managers and central office staff;
-
involving data managers in the development and review of the Data Management
Manual;
-
promoting liaison with other cooperative groups.
All those involved with the data management of NCIC CTG studies are automatically
members of this Committee.
1.5.3.9 - Data Safety Monitoring Committee (DSMC)
Data Safety Monitoring Committee Guidelines
The DSMC is charged with the responsibility of protecting patient interests
on NCIC CTG trials by providing an independent opinion on the suitability
of continuing to enroll patients on individual studies. Its primary role
is to review the results of protocol specified interim analyses; in this
setting it is the only group of individuals, in addition to the study statistician,
with access to data on study endpoints, broken down by treatment arm. However,
the DSMC may recommend stopping accrual to a trial for other reasons including:
-
unacceptable toxicity
-
external information which indicates that one or the other treatment arms
is no longer an acceptable alternative
-
accrual which is so slow that the study question will not be answered in
a reasonable length of time.
The terms of reference and composition of the DSMC were set to meet the
requirements of the NCI U.S. and have been approved by that organization.
The DSMC is, however, responsible for all NCIC CTG trials. In the case
of intergroup trials, the responsible DSMC is that of the lead group, which
is in some cases NCIC CTG. The DSMC is advisory to the Clinical Trials
Committee which has the ultimate responsibility for deciding whether to
close or publish a trial prematurely. In intergroup trials, the NCI U.S.
must be consulted, however, if the Group does not follow the advice of
the DSMC.
Currently, the DSMC has eight members, two of who are investigators
from outside NCIC CTG and two who are cancer survivors.
1.5.3.10 - Pharmacists Network
The goals of the Pharmacists Network are:
-
to promote the optimum utilization and standardization
of oncology pharmacy services in the development and conduct of clinical
trials
-
to improve communication and sharing expertise in
oncology issues and information between members, the central office and
other professional groups within the NCIC CTG for the ultimate benefit
of the cancer patient.
The Steering Group of the PN initiates new projects
as necessary, sets priorities, plans the activities and educational programmes,
and reviews the effectiveness of the group. Membership in the Pharmacists
Network is voluntary and consists of all pharmacists specializing in oncology
who are involved with clinical trials and affiliated with a NCIC CTG centre
in Canada.
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