Rationale
Embedded pragmatic trials bring clinical research and care together resulting in meeting patients where they are. Conducting pragmatic and point of care trials has the potential to strengthen real-world relevance of clinical trials. This may accelerate clinical research, expand the potential of research locations, improve patient experience and enable more patient diversity.
The Embedded Pragmatic Trials initiative is intended to support organizations planning embedded pragmatic trials by leveraging resources, proposing efficient and effect practices and fostering collaborations within the healthcare ecosystem.
To do this, TransCelerate is working with regulators, its Member Companies, and other stakeholders to:
- Improve the perception and awareness of embedded pragmatic clinical trials by collating available resources.
- Develop proposals for efficient and effective practices and operational comparisons to support sponsors to consider pragmatic trial designs.
- Understand challenges to implementing embedded pragmatic trials.
Solution
Enabling the Implementation of Pragmatic Elements at Scale: Summary Report from an FDA and TransCelerate Tabletop Exercise December 2024 – This public summary describes an informal, non-binding tabletop exercise conducted by TransCelerate in collaboration with FDA CDER’s Center for Clinical Trial Innovation (C3TI) held in December 2024. This tabletop exercise was held to facilitate structured dialogue, share experiences and challenges, and identify actionable opportunities for advancing the use of pragmatic elements in clinical trials.
Benefits
The initiative aims to:
- Increase the footprint of sites and patients who can participate in clinical trials by enabling embedded pragmatic trials when they are the right fit for a development program.
- Improve sponsor perception of embedded pragmatic trials by providing available resources and thought capital to better understand these trial types.
- Demonstrate the feasibility of embedded pragmatic trials to key stakeholders (e.g., regulators, sponsors, and sites) through partnerships and strategic engagements.
- Support greater understanding for sponsors of operational distinctions between traditional randomized controlled trials and embedded pragmatic trial design.