Clinical Research
Clinical research at LRCP is carried out through disease-specific multidisciplinary teams: breast, gastrointestinal, genitourinary, gynecological, head and neck, central nervous system, skin, thoracic, sarcoma, neuroendocrine, and through the Supportive Care Program. The CCRU has extensive experience across a spectrum of clinical trial activities and offers the following services:
- Access to a large patient population across multiple disease sites;
- Study design, protocol development and methodological advice;
- Database development, support and form design;
- Statistical support including sample size, analysis and interpretation of results;
- Management of ethics documentation, including initial submissions, amendments and safety reports;
- Completion of regulatory documentation;
- Patient recruitment;
- Case report form completion;
- Long-term follow-up for adjuvant trials;
- Design and maintenance of tumour bank and database projects;
- Sample collection for pharmacokinetic studies;
- Quality assurance;
- Liaison with granting agencies, the pharmaceutical industry and government; and,
- National and International Central Databases.
CCRU Highlights
- Regularly recruits 250-400 patients each year for 50 to 70 active trials.
- Has developed close collaborations with Cooperative Groups and Pharmaceutical Industry.
- Implemented quality control procedures which have been validated by multiple external audits (Cooperative Group, Industry, FDA).
- Staff have developed and published an innovative patient assessment record (PAR) of treatment toxicities, widely adopted by other clinical research programs.
- Major participation in studies which resulted in changes to standards of care.
The CCRU Team
- Clinical Research Coordinators are responsible for the organization, implementation, coordination and documentation of clinical research projects.
- Clinical Research Associates and Clinical Trial Research Assistants coordinate the follow-up phase for clinical trials subjects, complete case documentation and assist Clinical Research Coordinators with the coordination of active research projects.
- Clinical Trial Activation Coordinators are responsible for ensuring the regulatory requirements are complete.
- Data Management Coordinators maintain central databases for provincial, national and international multi-centre studies.
- A Biostatistician works with the LRCP professional/academic staff on the methodological and statistical aspects of their research.
- A Statistical Database Coordinator creates data management systems to facilitate data collection and analyses of retrospective and prospective LRCP-based research projects.
- An Ethics Regulatory Coordinator is responsible for initial and ongoing ethics approval submissions.
- An Administrative Assistant is responsible for ongoing administrative/secretarial support for all CCRU activities.
Partners and Collaborators
- Western University - Academic staff, Department of Oncology
- Canadian Cancer Clinical Trials Network
- Cooperative Groups such as the National Cancer Institute of Canada Clinical Trials Group, NRG Oncology, Ontario Clinical Oncology Group, European Organization for Research and Treatment of Cancer
- Pharmaceutical Companies
- Cancer Care Ontario - South West Regional Cancer Program
- Ontario Institute for Cancer Research
Helpful Links
- Canadian Cancer Society – Clinical Trials
- It Starts With Me
- ClinicalTrials.gov (U.S.A.)
- Ontario Cancer Trials
Contact
For more information on the CCRU, please contact Richard McClelland, Operations Lead, at 519-685-8618 or Richard.McClelland@lhsc.on.ca.
