About the Provincial Clinical Trial Management System Program
Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. Studies might involve new investigational drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.
People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the investigational medication and to have the additional care and attention from the clinical trial staff (Clinical Connection 2020).
A survey of 1,602 Ontario and British Columbia residents by Clinical Trials BC and Clinical Trials Ontario showed that 68% of respondents would be willing to participate in a clinical trial (Willison 2019). Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
A Clinical Trial Management System (CTMS) is a critical tool for improving the clinical research process at both a site and an institutional level. A CTMS maintains and manages planning, performing, and reporting functions, along with participant contact information, tracking deadlines and milestones. The use of a CTMS provides for easy, efficient, and secure organization of this data in a centralized location so trials can run more efficiently.
In order to meet regulatory requirements, any electronic system used to capture, process, manage and/or archive clinical trial information should be adequately validated and evidence of validation should be kept for the required record retention period and should be readily available for inspection by Health Canada’s Inspectors (Health Canada 2019).
An Opportunity for BC Clinical Researchers
Access to, and adoption of, a harmonized Clinical Trial Management System improves efficiency at the research site level while ensuring compliance with regulatory requirements.
Currently, sites and institutions within British Columbia use multiple systems and document management tools for study subject management, research regulatory compliance, reporting, study data capture, sponsor invoicing, research billing, and research administration. These systems are labour intensive to maintain and require manual inspections to ensure that documents are appropriately tracked and updated. Report development requires significant effort in data reconciliation and metrics on various aspects of trial management are not easily available.
Investigators in BC have access to various data collection systems across the institutions, such as REDCap, a free open source software tool, to manage their study data. However, these systems are not a substitute for a CTMS, and do not provide enterprise visibility across studies for reporting, budgeting, billing, and monitoring.
Establishing a BC AHSN provincial-level enterprise CTMS will provide a baseline system that allows sites to effectively manage complex studies, Multi-Regional Clinical Trials (MRCTs) and house electronic Master Files for sites investigator-initiated trials.
A CTMS for British Columbia
The BC Academic Health Science Network has committed to providing provincial research organizations and their investigators with a provincially-harmonized Clinical Trial Management System (CTMS).
A CTMS incorporates the processes used to plan, manage, and maintain clinical trials and is supported by cloud-based software which collects and stores trial data. The data is organized and presented as a clinical dashboard for research and trial managers. The ease of access to data and reports will improve clinical trials.
The overall program vision is to improve the management of clinical trials, by becoming more efficient, streamlined, informed, and collaborative. The program has three key objectives:
High-level CTMS Lifecycle
Below is a diagram indicating the lifecycle phases of a clinical trial and the associated processes using a CTMS (click the graphic for a larger version):
Benefits of a CTMS
There are several benefits of a well-run CTMS, including:
- Real-time insight into operations: A central place for recording operational activity, offering easy access to important information
- Better financial management: Offers consistent budgeting, speeds up and improves revenue recovery
- Enhanced billing compliance: Allows for streamlined communications between all parties to support billing accuracy
- Efficient regulatory process: Tracks and manages regulatory information across the enterprise
- Increased efficiency: Integrated processes reduce the need for duplicate data entry, tracks staff effort
Benefits of a ‘Provincially Managed’ CTMS Program
- Common Clinical Trial Management processes and tools: Allows for improvements, efficiencies, and scalability
- Access to a ‘Collaborative Community’: Builds a robust community that discusses operations and shares best practices which allows for continuous improvement
- Lower cost per trial: The more trials conducted, the lower the cost per trial – combining the total number of trials from all health authorities allows for a better price point
- Provincial reporting: Provides a holistic view as to what trials are being managed in the province, and their outcomes
Find out more about our collaborative program strategy on this page.
Our CTMS Program Team
Find out more about the full CTMS program team here.
Find out about the personnel structure of the CTMS program here.
Read our monthly updates below:
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