The Ontario Clinical Oncology Group (OCOG), established in 1982, is an academic-based clinical trials development and coordination organization. OCOG works with investigators to conceive, design, coordinate, conduct, analyze and publish clinical trials with a focus primarily on cancer research (with a secondary interest in venous thrombosis). Together with a network of local, provincial, national and international clinician investigators, OCOG, through clinical research, addresses clinically relevant questions, with the ultimate goal to impact and improve patient care.
The specific objectives are to:
OCOG conducts phase I, II, and III clinical trials, diagnostic accuracy studies, cohort studies, case-control studies etc., ranging in size from 20 to several thousand patients through participating clinical sites. OCOG has conducted trials provincially, and nationally, within the USA, Europe, Australia and New Zealand.
The OCOG Coordinating and Methods Centre (CMC), located at the Hamilton Health Sciences Juravinski Hospital and Cancer Centre, in Hamilton, Ontario, has more than 20 individuals including methodologists, clinician researchers, statisticians, research coordinators, data management staff, IT personnel, financial and contracts specialists.
OCOG is affiliated with the Department of Oncology, Faculty of Health Sciences, McMaster University.
OCOG is one of the core components of the Escarpment Cancer Research Institute (ECRI) which is a joint Hamilton Health Sciences (HHS) and McMaster University Research Institute.
The OCOG Coordinating and Methods Centre (CMC) is responsible for monitoring study execution, particularly with regard to methodological aspects and ensuring each clinical site adheres to the study protocol. Study metrics are monitored through a Clinical Trial Management System. Web-based randomization is performed by the participating clinical sites utilizing the CMC’s Interactive Registration/Randomization System (IRIS). A secure and confidential electronic trial management and clinical database is maintained by the CMC. Data collection is performed via an EDC system. The CMC’s Online Remote Collection of Clinical Information and Data (ORCCID) system incorporates a clinical database, data query process, visit management tracking, and SAE tracking to ensure data is complete, accurate, of high quality and is reported/submitted according to required timelines. Designated personnel at participating clinical sites are provided with member access to OCOG’s website to obtain study documents, operations manuals, monthly status reports and newsletters.
In most cases OCOG acts as the “sponsor” for clinical trials, expanding the regulatory and management responsibilities of the personnel working on these trials. OCOG may also take on the role of Data Coordinating Centre (DCC), working cooperatively with an independent Clinical Coordinating Centre (CCC).
In addition, the OCOG CMC has an in-house safety desk with assigned Physician Research Associates as well as an established independent Data Safety Monitoring Committee to monitor all serious adverse events (SAEs) and ensure timely review and submission of safety reports and SAEs to regulatory agencies, participating clinical sites and ethics boards.
Standard operating procedures support and guide all aspects of research at OCOG. The CMC has an established SOP development and review committee. Research staff are GCP certified and Research Coordinators are accredited as Certified Clinical Research Professionals (CCRP) with the Society of Clinical Research Associates (SoCRA).
OCOG has undergone Health Canada inspections and received a fully ‘Compliant’ rating.
For patient enrolment, OCOG uses a web-based Interactive Registration and RandomIzation System (IRIS). Using standard browsers and a secure internet connection, IRIS allows users to access study-specific forms and instructions, collect key data required for randomization and treatment allocation. IRIS has the flexible design to support multiple randomization methods: stratified designs using predefined allocation or dynamic schemes; random-sized permuted blocks; stochastic minimization (we can preset the allocation probability); multi-stage randomization designs; eligibility checks; and open or blinded treatment allocations.
Clinical centre data is collected via the OCOG web-based "Online Remote Collection of Clinical Information and Data (ORCCID)" system. A single platform supporting both electronic data capture (EDC) and clinical trial management systems (CTMS) functionality, ORCCID has the flexibility to support any clinical trial design, as well as the unique aspects of individual clinical trials. It provides a deep range of tools for capturing clinical trial data.
Key features of IRIS and ORCCID include: compliant with global regulatory requirements, including 21 CFR Part 11; web-based interface that works on any computer; intuitive and easy to use with an integrated e-Learning feature to ensure rapid user adoption and compliance; centralized treatment allocation that ensure concealment; patient screening and screen failure tracking; continuous monitoring of trial progress; real-time edit checks – includes checking forms across CRFs and visits; seamless integration with EDC system; highly configurable workflows and security permissions for data entry, review and approval; and SAE tracking.
Validated EDC systems:
The IRIS and ORCCID systems are two-tier applications: the “front-end” is installed on a Microsoft IIS web server, and the “back-end” is Microsoft SQL server. Both servers employ the MS Windows Operating system. The servers are located in a dedicated server room at McMaster University and are separated from the large McMaster University network by Cisco firewall. The server room has restricted access, emergency power and two independent internet feeds. Designated personnel at participating clinical centers are provided with member access to OCOG’s website to obtain study documents, operations manuals, monthly status reports and newsletters. The following precautions ensure that patient confidentiality is maintained according to International Conference on Harmonization (ICH) Good Clinical Practices (GCP), Health Insurance Portability and Accountability Act (HIPPA), and the US Food and Drug Administration (FDA) standards: (1) personal identifiers (e.g. name, address, telephone numbers) are not entered in the electronic database (this data will be stored in a secure location with restricted access at the clinical centers) and will be removed from all source documentation and patient material that is sent to OCOG (e.g. clinic notes, diagnostic imaging); (2) Clinical centers will require a complex password to gain access to any web-based data or documents; (3) OCOG databases are password-protected with strong encryption and incorporate various firewalls and isolated networks; (4) all access attempts to the OCOG database is logged; and (5) all data will be destroyed after 25 years. All OCOG practices comply with McMaster University and Hamilton Health Sciences joint “Standard Operating Procedures for Clinical Research”.
All OCOG personnel have in-depth knowledge and extensive experience with the software used in conducting clinical trials. All study-related computing systems were developed by OCOG IT personnel. The software can be readily tailored to meet the needs of various clinical trial designs.