Clinical research plays a vital role in lessening the growing burden of cancer in Ontario and is part of the overall mission of the London Regional Cancer Program (LRCP) and Cancer Care Ontario. The Clinical Research Unit (CRU) coordinates and supports protocol management and clinica/translational research projects identified by the academic staff of LRCP as carrying high impact for advancing cancer knowledge and improving care for our patients. In doing so, the CRU employs best practices to prioritize and conduct research projects in a transparent, safe, efficient, and sustainable fashion.
Clinical Research at the LRCP is carried out through nine disease-specific multidisciplinary teams: breast, gastrointestinal, genitourinary, gynecological, head and neck, central nervous system, skin, thoracic, sarcoma, neuroendochrine, and through the Supportive Care Program.
The CRU has extensive experience across a spectrum of clinical trials activities, and offers the following services:
- access to a large patient population across multiple disease sites
- study design, protocol development and methodological advice
- data base development and 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 data base projects
- sample collection for pharmacokinetic studies
- quality assurance
- liaison with granting agencies, the pharmaceutical industry, and governments
- National and International Central Databases
- Operational since 1982 as part of a University-based comprehensive cancer centre
- Regularly recruit 250-400 patients each year to 50 to 70 active trials
- Unit 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 in standards of care
- 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 CRU activities.
- University of Western Ontario - Academic staff, Department of Oncology
- London Health Sciences Centre
- 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 Regional – Southwest
- Ontario Institute for Cancer Research
- Ontario Cancer Research Network
- Lawson Health Research Institute