Princess Margaret Cancer Centre, University Health Network ~ Canadian Researcher

The Princess Margaret Cancer Centre has achieved an international reputation as a global leader in the fight against cancer and delivering personalized cancer medicine. The Princess Margaret, one of the top five international cancer research centres, is a member of the University Health Network, which also includes Toronto General Hospital, Toronto Western Hospital and Toronto Rehabilitation Institute. All are research hospitals affiliated with the University of Toronto.

At Princess Margaret, over 160 researchers, 370 trainees and 460 technical support staff collaborate to gain a better understanding of cancer and to develop strategies to prevent, treat and cure cancer.

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ONTARIO CANCER INSTITUTE

The Ontario Cancer Institute, the research arm of the Princess Margaret Cancer Centre, is one of the top 5 cancer research centres in the world. Our team of internationally recognized scientists is housed in a 385,000 square foot cutting-edge research facility equipped with state-of-the-art tools. Our researchers study stem cells, cell signaling, cell biology, structural biology, immunology and immune therapy, molecular imaging, guided therapeutics, psychosocial oncology, palliative care, genomics, proteomics, bioinformatics and other innovations that are moving findings from the ‘bench to the bedside and back to the bench.’

The Ontario Cancer Institute is comprised of The Campbell Family Cancer Research Instituteand The Campbell Family Institute for Breast Cancer Research.

CANCER CLINICAL RESEARCH UNIT

Improving the quality and productivity of clinical research at Princess Margaret and encouraging a culture of innovation, responsibility and accountability within the clinical research community.

s one of the largest clinical research centres dedicated to improving treatment for people with cancer, the Princess Margaret Cancer Clinical Research Unit (CCRU) provides leadership, oversight and infrastructure for researchers within the Princess Margaret Cancer Centre. Every year Princess Margaret initiates upwards of 100 new clinical trials – at any one time we have close to 300 trials underway.

The CCRU is the central point of contact for any questions about the conduct of clinical research at Princess Margaret. Our team of dedicated internationally recognized experts helps guide investigators and study teams to achieve the highest quality research. The CCRU will be moving to a new location in the summer of 2012, and this new state-of-the-art facility will bring our clinical research staff together and facilitate collaboration, as well as provide space for meetings, monitoring visits and storage.

Our departments and programs are:

Find out more about clinical trials at Princess Margaret.

RESEARCH PROGRAMS

Our research programs cover a wide range of cutting edge innovation and discovery.

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OPERATIONALIZING CLINICAL RESEARCH

The CCRU is committed to ensuring that Princess Margaret’s research is operationally efficient and of high quality. To achieve this goal we have initiated the following:

Standardized practices, including standard operating procedures, regulatory binders and study charts
A comprehensive education program, including sessions targeting the needs of clinical trial nurses and study coordinators
Quality and metrics reporting, which includes routine reporting and review of program-wide performance and constant engagement of Princess Margaret Cancer Centre constituents about program metrics, best practices and fiscal responsibility
Training and support for highly skilled clinical research professionals, including clinical study coordinators for study management and clinical trial nurses who practice patient-centred care

To enhance the quality of investigator-initiated trials, the CCRU supports the use of our Electronic Data Capture System, Medidata Rave, at Princess Margaret. Medidata Rave is a dependable, high-quality clinical data management system that captures and stores clinical research data, which is critical to the validity and reliability of the data.

DEPARTMENTS & PROGRAMS

As one of the largest clinical research centres dedicated to improving treatment for people with cancer, the Princess Margaret Cancer Clinical Research Unit’s departments and programs are:

BIOSTATISTICS

The Biostatistics Department at Princess Margaret Hospital/Ontario Cancer Institute (OCI) is a research-support department within the Cancer Clinical Research Unit that collaborates with Princess Margaret/OCI clinical and basic researchers in a broad spectrum of oncology studies to provide statistical design and analysis expertise.

Supporting approximately 150 biostatistical requests per year, our services include the design of trials and analysis of retrospective and prospective clinical research studies and trials. We also provide Princess Margaret residents and fellows with courses in statistics.

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.

For additional information about our services, please contact Tony Panzarella, atpanzar@uhnresearch.ca.

WHAT IS A CANCER REGISTRY?

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

OPERATIONS

Functionally, the Cancer Registry is part of the Cancer Clinical Research Unit within Research at UHN. The Cancer Registry and Data Access Committee (CRDAC) advise 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 is comprised of physician representatives from the departments of Medical Oncology & Hematology, Pathology,Radiation Oncology and Surgical Oncology. In addition, there is a representative from theBiostatistics department and the Committee’s Secretariat oversees the processing of the data requests.

DATA AND AUTHORIZATION

While Research Ethics Board approval is a mandatory prerequisite for data collected for research purposes, the results are devoid of patient identifying information. 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 Darlene Dale atdarlene.dale@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 and 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 HarmonisationGuideline for Good Clinical Practice (ICH GCP) and has highly trained and dedicated staff with 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 the validity and reliability of study data.

The CTSU’s services include:

Health Canada Clinical Trial Application preparation and submission
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 Vanessa Speers atVanessa.Speers@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 Nurse 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 atMarcia.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. We annually collect and process approximately 75 fresh tumour biopsies, 100 skin biopsies, 650 archival tissue specimens, 20 bone marrow specimens and 8,000 blood samples for pharmacokinetic, pharmacodynamic, pharmacogenomic and biomarker evaluation studies.

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 atCCRUcorrelativestudies@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 in regard 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 Jasmine Brown atjasmine.brown@uhnresearch.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)).
The time to open new studies was reduced by 32% from 2008 to 2010.
Princess Margaret operates 300 open trials per year and opens 100 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 (www.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 Practiceis 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 more information, go to www.theprincessmargaret.ca or www.uhn.ca .

Sunday, March 6, 2016