Cancer Clinical Research Unit

Biostatistics

The Biostatistics Department at Princess Margaret Cancer Centre is a research-support department within the Cancer Clinical Research Unit. Biostatistics collaborates with Princess Margaret clinical and basic researchers in oncology studies, providing statistical design and analysis expertise.

Supporting approximately 150 biostatistical requests per year, our services include:

• Trial design
• Analysis of retrospective and prospective clinical research studies and trials
• Statistics courses for Princess Margaret residents and fellows

We are closely affiliated with the Division of Biostatistics at the Dalla Lana School of Public Health at the University of Toronto, where our staff teach statistics courses and sit on several key committees, such as the Admissions Committee. We also participate in an internship program through which we train biostatisticians.

• See also: Division of Biostatistics at the Dalla Lana School of Public Health

Cancer Registry

A cancer registry collects, interprets and stores specific types of information that comes from the clinical records of individuals who have been diagnosed with cancer. Cancer registries are valuable sources of information for researchers working to understand the causes, diagnosis, treatment and outcomes for people with cancer.

The Princess Margaret Cancer Registry has been in operation since the opening of the Princess Margaret in 1958. It is the only hospital-based cancer registry in Ontario and the largest in Canada. The registry provides high quality information on all University Health Network (UHN) cancer patients treated at Princess Margaret, Toronto General Hospital and Toronto Western Hospital. This data can then be used for administrative, quality control and research purposes. This registry has a standardized process and database for the collection of information on diagnosis, disease, staging, treatment, follow-up and outcomes of UHN patients treated for cancer.

The Cancer Registry is part of the Cancer Clinical Research Unit within Research at UHN. The Cancer Registry and Data Access Committee (CRDAC) advises on the operational issues relating to data collection and cancer staging. The Committee is co-chaired by both the Medical Director and the Head of the Cancer Registry and comprises physician representatives from the departments of Medical Oncology & Hematology, Pathology, Radiation Oncology and Surgical Oncology. There is also a representative from the Biostatistics Department, and the Committee’s Secretariat oversees the processing of the data requests.

• See also: Princess Margaret Department of Medical Oncology & Hematology
• See also: Pathology at UHN
• See also: Princess Margaret Radiation Medicine Program
• See also: Surgery at UHN
• On this page: Biostatistics Program
  
  

While Research Ethics Board approval is a mandatory prerequisite for data collected for research purposes, the results do not contain any information identifying the patient. All submissions for data undergo a stringent review process covering the aspects of collection and statistical interpretation of the data, the scientific method and feasibility prior to receiving a UHN Institutional Authorization (IA). The granting of IA is mandatory before the research can commence.

The cancer registry produces a report of the data every two years.

For additional information about our services or to request data, please contact Mary Madunic at mary.madunic@uhn.ca.

Clinical Trial Support Unit

The Clinical Trial Support Unit (CTSU) within the CCRU provides expert study management services for the Princess Margaret Cancer Program. The CTSU has expertise in managing industry, intergroup and investigator-initiated studies. The CTSU can perform all regulatory and data management requirements for successfully conducting a study, from site initiation to study closure and archiving.

The CTSU conducts all studies as indicated by the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH GCP). Dedicated staff are highly trained and have expertise in managing trials regulated by Health Canada and US Food and Drug Administration.

The CCRU also manages and acts as the database administrator for the Medidata Rave electronic data capture system. Princess Margaret implemented this database in 2010 to support investigator-sponsored, prospective, interventional clinical studies data management and reporting to ensure validity and reliability of study data.

The CTSU’s services include:

• Research Ethics Board submission and approval
• Budget review and negotiation
• Study start-up
• Regulatory reporting of serious adverse events
• Preparation for Data Safety Monitoring Board study review
• Data management, including data entry, query resolution, monitoring visit coordination and follow-up
• MediData eCRF design and development, user maintenance and database monitoring
• Ongoing regulatory support
• Audit preparation
• Archiving of study documents

For additional information about our services, please contact Liesa Baumann at liesa.baumann@uhn.ca.

Clinical Trial Nursing

There are more than 45 clinical research nurse coordinators at Princess Margaret. These specialized oncology nurses provide patient-centred care for the duration of a clinical trial. This challenging and innovative role continues to evolve.

Competencies include:

• Collaborating with the study team and with patients and their families to implement protocol-specific procedures, from screening to study completion
• Ongoing education of patients, families and ancillary departments to facilitate compliance with the study protocol
• Assessing patient adverse events, using knowledge, skill and judgement to determine dose-limiting toxicity, maximum tolerated dose and disease response in collaboration with the Principal Investigator
• Documenting assessments, interventions and evaluations in adherence to ICH GCP, UHN research documentation standards and College of Nurses of Ontario documentation standards
• Advocating for the ethical care of clinical trial patients
• Participating in professional development activities to ensure ongoing competency in clinical trials and nursing practice

For more information about clinical research nurses, please contact Marcia Flynn-Post at Marcia.Flynn-Post@uhn.ca.

Correlative Studies Program

The CCRU Correlative Studies Program provides services and expertise to facilitate all aspects of biospecimen management for clinical trials, such as bio-specimen collection, processing, handling, storage, shipping, tracking and documentation.

The Correlative Studies Program provides services to an average of 80 new clinical trials each year, as well as continuing services for up to 200 ongoing clinical studies. Each year, we collect and process the following for pharmacokinetic, pharmacodynamic, pharmacogenomic, and biomarker evaluation studies:

• 75 fresh tumour biopsies
• 100 skin biopsies
• 650 archival tissue specimens
• 20 bone marrow specimens
• 8,000 blood samples

The program draws on highly skilled correlative research technicians, who provide consistency in the procurement process to ensure high-integrity, high-quality biospecimens for correlative studies, and a correlative research coordinator, who facilitates pre-screening procedures for patients who require mutational analysis of their archived tumour tissue prior to registration.

All staff are trained on study-specific protocol procedures, institutional laboratory guidelines, Good Clinical Practices, Good Laboratory Practices and departmental Standard Operating Procedures.

We maintain a Level II laboratory available to all other clinical research personnel processing blood specimens.

For additional information about our services, please contact us at CCRUcorrelativestudies@uhn.ca.

Education & Training

CCRU has a collaborative team that includes a clinical trials nurse educator and a study coordinator education specialist. This team focuses on training, standardization of processes and communication to enhance the quality and productivity of the clinical trials enterprise at Princess Margaret.

Our training program consists of instructor-led presentations, mentoring of new staff and an e-Learning program. Our communication plan involves presentations of CCRU metrics and initiatives delivered across departments to raise awareness of our clinical trial productivity and operational efficiency.

Since 2010, we have been hosting a program-wide Education Day for all clinical research staff. This full-day event highlights practice-changing clinical trial work across the centre.

Well-organized record-keeping promotes both accountability and integrity in research and allows for accurate reporting, interpretation and verification of clinical study information. Standardization of the research chart ensures continuity among all studies as it relates to source document organization, improvement of the monitoring/auditing and data collection processes, and facilitation of cross-coverage of studies by clinical study teams.

We regularly keep the Princess Margaret community informed of current events and release a quarterly newsletter, the CCRU Times.

For additional information about our services, please contact CCRU Education at CCRUEducation@uhn​.ca.

Metrics & Process Improvement

The Metrics and Process Improvement program reports on clinical research performance metrics and oversees the conduct of various clinical research processes within the Princess Margaret Cancer Centre.

Princess Margaret metrics:

• Twenty per cent of all patients treated at Princess Margaret participate in a clinical trial, compared with the provincial level of 8%.
• The rate of zero-accruing studies is 8.5%, compared with 28.6% at North American cancer centres (Dilts et al, Clin Cancer Res. 2010;16(22)).
• Princess Margaret operates 350 open trials per year and opens 150 new trials per year.
• Quarterly and annual reports on performance are shared at the management, principal investigator and division head levels.

Clinical research processes supported:

• Data Safety Monitoring Board for investigator-initiated studies (single and multi-site)
• Public posting of active clinical trials for investigator-initiated studies (clinicaltrials.gov)
• Central listing of all studies within the program
• Patient education and communication about available studies

For additional information about our services, please contact ClinicalTrials-PMH@uhn.ca.

Quality Assurance

The Quality Assurance Department of the CCRU supports a structure to ensure high-quality research at the Princess Margaret Cancer Centre. The ICH Guideline for Good Clinical Practice is the standard for conducting all Princess Margaret clinical trials.

The health and safety of our study participants is paramount. As part of the quality system, Quality Assurance is responsible for developing, reviewing and approving standard operating procedures. Compliance with these procedures ensures that clinical research studies are conducted and data are generated, documented and recorded in compliance with the protocol, Guideline for Good Clinical Practice and applicable regulations.

The CCRU assesses quality through Quality Assurance Reviews, which verify that research studies are conducted in compliance with the study protocol, applicable regulations, standards operating procedures and institutional policies. Reports from audits conducted by external parties are also collected and tracked centrally.

In conjunction with the Education and Training component of the CCRU, the Quality Assurance team develops standard tools and processes for the Princess Margaret clinical research community and reviews the efficiency of these processes as they are incorporated into workflow.

For additional information about our services, please contact Susanna Sellmann at susanna.sellmann@uhnresearch.ca.​​