Disease Site Committees
Disease site committees discuss proposals for new studies, consider their scientific merit and feasibility, and assign priorities when necessary. Currently, there are 11 disease site committees including brain, breast, lung, gastrointestinal, genitourinary, gynecologic, hematologic, lung, melanoma, sarcoma, and symptom control. Each committee is made up of both members and executive members.
Disease Site Executive Committees
Each disease site committee has a chair and an executive. The primary role of the disease site executive committees is to review studies proposed by their respective site committees and, on the basis of that review, to recommend trials for consideration to the Clinical Trials Committee in order of priority.
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 largely determined, however, 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.
IND Executive Committee
The IND Executive Committee acts to provide ongoing review of the specific program goals and priorities, as well as review and approval (or not) of specific trial proposals. The Executive meets in person or by telephone 4-6 times per year. Members of the Executive include the Chair of the IND Committee, Central Office staff, IND investigators, and basic scientists.
There are several standing committees that actively contribute to the activities of the NCIC CTG. These include: Clinical Trials Committee, Clinical Research Associates Committee (including Disease Site Committee Reps and the CRA Committee Executive Committee); Data Safety Monitoring Committee, Pharmacists Network Steering Group, Quality Assurance Committee, Quality of Life Committee, Radiation Oncology Quality Assurance Committee, Correlative Sciences/Tumour Bank Working Group, and the Working Group on Economic Analysis.
The overall purpose of this Committee is to advise on and supervise NCIC CTG quality assurance/quality control programs. Specific functions include:
Reviewing the results of on-site visits and make recommendations for improvements when problems are detected;
Approving measures to be used in assessing "centre performance," set desired standards of performance for those measures, and establish minimal acceptable criteria and reproval mechanisms;
Reviewing recommendations from modality committees on quality control measures specific to their modalities.
The Clinical Research Associates (CRA) Committee (formerly the Data Management Committee) was established in 1988 with a mandate to improve the quality of NCIC CTG clinical trials of therapy in cancer and supportive care through the following mechanisms:
Providing input by CRAs into protocol and forms design;
Participating in disease site and standing committee discussions and decisions;
Providing training and educational programmes for CRAs;
Improving communication among CRAs and with central office staff;
Developing/maintaining a data management manual; and,
Promoting liaison with other cooperative groups.
The Group executive is called the Clinical Trials Committee. This Committee is responsible for advising the Director on all substantial issues concerning the NCIC CTG clinical trials programme. The Director appoints members 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 (e.g., authorship of publications).
The CTC is also responsible for receiving and acting on the recommendations of the Data Safety Monitoring Committee. Finally, it recommends overall policies such as the level of per capita funding, the establishment of new disease site committees, etc.
The NCIC CTG has had a Correlative Studies and Tumour Bank Programme in place since the inception of the Tumour Bank Working Group in 1995. The mandate of this original working group was to develop a tumour/tissue bank for NCIC CTG trials, largely focusing on phase II studies. The Committee's initial role was to develop guidelines and policies for the collection, storage, and distribution of patient specimens from NCIC CTG studies with the intent of ensuring that a tumour/tissue bank was available for correlative science research questions developed in conjunction with ongoing trials, or to answer questions that would arise in the future.
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.
The role of Lay Representatives in the NCIC Clinical Trials Group is to represent the perspective of patients and their families, and the public at large, in the development and delivery of clinical trials. The goal is to team with health care professionals/researchers to advance outstanding research in the treatment, care, and prevention of cancer.
The mission of the Pharmacists Network is to:
Promote the optimum utilization and standardization of oncology pharmacy services in the development and conduct of clinical trials; and,
Improve communication and share 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 Quality of Life (QOL) Committee was initially formed as a working group in 1986 and became a standing committee in 1987 in recognition of the growing consensus that there was/is a need to consider quality of life endpoints in phase III clinical trials. Its responsibility is to provide methodological and practical support for collection of health-related quality of life (HRQOL) in clinical trials conducted by the NCIC CTG.
Radiation Oncology Quality Assurance Committee
This committee was formed to oversee quality control of radiotherapy on NCIC CTG studies. The Committee reviews/amends the radiotherapeutic sections of new protocols and oversees real-time review of the prescription, dose-distribution, and radiotherapy fields for patients on trials involving this process.
The Committee on Economic Analysis (CEA) was established in 1996 because the leadership of the NCIC CTG recognized that economic factors were becoming increasingly important in decision-making regarding the adoption of new therapies. Rising health care costs and the modest benefits of many cancer therapies made it important to explore the economic benefit of a new therapy at the same time as its therapeutic benefit.
Clinical Trial/Study Committees
Generally, trial committee members are drawn from their respective disease site committees. Trial committees:
Develop and write the trial protocol, with the assistance of central office;
Make recommendations for modifications as necessary while the trial is in progress;
Participate with central office and the Clinical Trials Committee in decisions regarding termination of the study; and,
Write and submit the results of the study for publication.