GetReal Trial Tool
The GetReal Trial Tool is an online tool that helps researchers design clinical trials that better reflect real-world patient care. It allows users to see how different trial design choices affect how applicable the results will be to everyday medical practice, while also considering reliability, accuracy, and practical challenges.
At a glance
Use when
Designing pragmatic clinical trials; planning trials with real-world evidence components; seeking to improve generalizability and stakeholder acceptance of trial results
Avoid when
Conducting highly controlled explanatory trials where real-world applicability is not a priority; when real-world data infrastructure is unavailable
Inputs
Clinical trial design choices (e.g., eligibility criteria, comparator selection, outcome measures, data collection methods, use of real-world data sources)
Outputs
Assessment of generalizability, risk of bias, precision, acceptability, and operational feasibility; guidance for optimizing trial design
How it works
The GetReal Trial Tool is a web-based application designed to support the integration of Real World Evidence elements into clinical trial design. It enables users to evaluate trade-offs between generalizability, risk of bias, precision, acceptability, and operational feasibility. The tool is informed by scientific literature and expert input from academia, industry, regulatory agencies, HTA bodies, and patient organizations. It supports the design and assessment of pragmatic trials to improve relevance and translation of trial results into routine care.
- Project
- GetReal
- Funding
- IMI
- Project status
- Completed 2021
- HTA domains
- Clinical Effectiveness
- Categories
- RWE
- Technology
- Non-specific
- Assumptions
- Design choices can be systematically evaluated to improve real-world relevance; stakeholder input enhances tool validity; pragmatic trial designs can generate acceptable evidence for decision-making
- Strengths
- User-friendly interface; integrates multiple evaluation domains; developed with multi-stakeholder input; supports early design optimization; promotes alignment with regulatory and HTA expectations
- Limitations
- May not cover all context-specific operational challenges; acceptability of outputs depends on evolving regulatory and HTA standards; limited validation in diverse therapeutic areas
- Also known as
- GetReal Trial Tool, GetReal Tool
Questions this answers
- › How can I make my clinical trial more relevant to real-world practice?
- › What design choices improve the generalizability of my trial results?
- › How do my trial design decisions affect bias and precision?
- › Will regulators and HTA bodies accept evidence from my pragmatic trial?
- › What operational challenges should I expect when adding real-world elements to my trial?
- › How can I balance scientific rigor with practical feasibility in trial design?
Similar by meaning
Beta record. Generated from the primary source via AI extraction and independent audit, pending final human review.