Clinical Research Program
The Clinical Research Program oversees the administration of Phase I-II-III oncology clinical trials at McGill University.
- To encourage the introduction and development of state-of-the-art research protocols, appropriate for the care of cancer patients.
- To uphold internal monitoring procedures to ensure quality and safety.
- To maintain a central administrative
structure to manage the following:
- ensuring the peer review of studies before their initiation;
- the hiring, training, and supervision of data managers;
- the execution of agreements in a consistent and timely fashion with industrial sponsors, in accordance with University policies, and provincial and federal regulations.
The Program’s administrative office is responsible for assembling and disseminating all information and documentation regarding clinical trials, including study protocols, consent forms, serious adverse events reports, regulatory documents, applications for continuing review and applications for study termination. It is also responsible for scheduling sub-committee meetings, distributing study supplies to the hospitals and for handling the financial aspects of the studies.
The administrative staff interacts directly with trial sponsors, principal investigators, the McGill Office of Technology Transfer, the McGill Institutional Review Board (IRB), the ethics boards, and data management administrators and pharmacies at the four hospitals involved (Sir Mortimer B. Davis-Jewish General Hospital, St. Mary’s Hospital, the MUHC-Royal Victoria Hospital, and the MUHC-Montreal General Hospital).
Most of the Program’s studies are sponsored by industry, primarily pharmaceutical and biotechnology companies. This is most likely driven by several factors:
- A means for the pharmaceutical industry in Canada to increase research funding to universities, as outlined in the last revision of the patent law;
- A desire on the part of clinical investigators to have access to, and to be part of, the formulation of new therapies;
- The need for revenue-generating programs that enable the simultaneous participation of the Department of Oncology in high priority, but inadequately funded, studies, such as cooperative group studies and unfunded McGill investigator-initiated clinical studies.
||Dr. Wilson Miller
(514) 340-8222 x4365
|Dr. Catalin Mihalcioiu
(514) 934-1934 x 35800
|Program Manager:||Penny Chipman