Pragmatic Trials Stream
The Pragmatic Trials Stream is being developed as part of the Accelerating Randomized Trials (ART) Platform.
This Stream will focus on streamlined trials testing solutions, which are simple, scalable, and sustainable, and will support trial researchers as they conduct critically-needed, pragmatic, large scale randomized trials.
The trials provide the same quality evidence as traditional trials in less time and at a substantially reduced per-patient cost. This Stream builds capacity and leverages existing expertise and data assets to test health care solutions that are simple, scalable, and sustainable.
The Pragmatic Trials Stream is ‘disease-agnostic,’ helping researchers avoid logistical barriers that often impede traditional multi-centre trials.
We would be pleased to speak with you about your ideas for a pragmatic trial and to answer any questions you may have to foster your work.
Please complete the following questionnaire to get our conversation started. We will review your submission and connect with you as soon as possible.
For further information on this stream, please contact Research@schulich.uwo.ca.
The Pragmatic Trials Stream offers a number of services or referrals to interested researchers, including:
1. Protocol Development and Refinement of:
- Trial design
- Intervention and delivery (including implementation considerations in busy routine care)
- Best approach to adherence monitoring
- Comparator group
- Trial data requirements, including use of secondary data sources and linkages
- Approach to analytics, randomization, and consent
- Patient facing materials
- Materials to socialize trial with health professionals and healthcare administrators
- Patient partnerships and input
- Indigenous rights and data sovereignty, IDEA principles
- Quality Control.
2. Pilot Trials and Full Trial Execution
Site engagement, training, support trial needs
3. Analysis of Existing Administrative Data to Guide Trial Conduct
- Understanding number of participants who meet trial inclusion criteria
- Where participants are located
- Their health services and patterns, including transitions to different regions or states
- Outcome event rates
4. Administratively Supporting Partnerships
- Partnering with patients using best practices
- Partnerships with private sector, public sector
- Partnerships with healthcare administrative data organizations (e.g., ICES, HDRN Canada)
- Supporting team meetings, meeting minutes, protocol documentation
5. Human Resource, Administrative, and Governance Planning for Trials
6. Grant Planning, Preparation, Submission, and Reporting
7. Trial Ethics
Planning and navigating considerations when using efficient or alternate methods of consent in multi-centre ethics applications8. Supporting Inter-Institution Contracts
9. Support to Establish Data and Safety Monitoring Board (including terms of reference)
10. Trial Budget Creation, Monitoring, Invoicing
11. Trial Management
Progress tracking, metrics, reporting
12. Communications
Internal meetings, committee meetings, newsletter creation and distribution
