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

Helpful Links

Contact

For more information on the CCRU, please contact Richard McClelland, Operations Lead, at 519-685-8618 or Richard.McClelland@lhsc.on.ca

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