Clinical Trials Methodology Group (CTMG)

CTMG evaluates treatments that improve patient care through the conduct of clinical trials. We are located within the Henderson Research Centre and are affiliated with the Department of Clinical Epidemiology & Biostatistics, McMaster University, and the Juravinski Regional Cancer Centre.

The Group – consisting of methodologists, statisticians, clinical researchers and research staff – carries out trials in  patients with cancer and  and venous thromboembolic disease. We collaborate with McMaster Faculty of Health Sciences colleagues, industry, other institutions, and government and serve as a training resource and site for young investigators.

CTMG researchers conceive, design, organize, manage, analyze, and publish clinical trials. We conduct phase 1, phase 2, and phase 3 trials ranging in size from 25 – 15,000 patients through clinical centers world-wide.  We also provide adjudication of outcomes for trials evaluating new anti-thrombotic agents.

CTMG has engaged in trials with pharmaceutical companies that have led to the registration of new drugs with government regulatory agencies such as the Health Protection Branch in Canada and the FDA in the United States. Some trials are supported by agencies such as the Canadian Institutes for Health Research, the National Cancer Institute of Canada, the Heart and Stoke Foundation, the Canadian Breast Cancer Research Alliance, the Ontario Ministry of  Health and Long Term Care and Cancer Care Ontario.

Ontario Clinical Oncology Group (OCOG)

Dr. Mark Levine, Co-director, helped to establish the Ontario Clinical Oncology Group (OCOG) in 1982. Dr. Kathleen Pritchard joined OCOG as a Co-director in 1999.

OCOG provides the following services:

·   Trial coordination and analysis

·   Research Methods workshops

·   Help to oncologists to develop questions into protocols

·   Training of research fellows.

OCOG exists within the Clinical Trials Methodology Group. Over 7000 cancer patients have been entered into OCOG trials studying cancers of the breast, head and neck, ovary, prostate, lung, and brain metastases, and pre-malignant conditions of lung and cervix.

Among the current trials that OCOG is conducting are trials evaluating: PET imaging in oncology, novel radiation fractionation regimens in women with early stage breast cancer who have undergone lumpectomy and in men with early stage prostate cancer, novel chemotherapy and biologic therapy in lymphoma, approaches to reduce the morbidity of lymph edema in women with breast cancer, tumour vaccines in breast cancer, and the anti-angiogenic effect of low molecular weight heparin in ovarian cancer.

CTMG Role: Typical Study with Pharmaceutical Sponsor

Provide scientific leadership/oversight

Pre-trial assembly of membership for:

·   Steering Committee (SC)

·   External Safety & Efficacy Monitoring Committee (ESEMC)

·   Central Validation Committee

·   Operational Executive

In collaboration with Sponsor provide input into the development of the study protocol, CRFs, study aids, and Operations Manuals and establish data management systems.

Able to provide 24-hour randomization with associated drug inventory.

Approach colleagues representing existing Research Networks to secure collaboration and participation

In collaboration with Sponsor provide input into the selection of Clinical Centres

Act as an Operational Executive with key members of Sponsor.

Provide overall coordination of the Study including: overseeing data flow from clinical centers.  data verification and data entry, AE and SAE reporting, and ongoing study reports.

Liaise with Sponsor/CRO responsible for monitoring

Participate in the planning and execution of Investigator Meetings. Provide support materials and agenda items

Participate in meetings with Regulatory Authorities

In collaboration with Sponsor, develop the analysis plan for the study