From trials to reality: Understanding the target trial framework in evidence generation
The target trial framework (TTF) is gaining increasing attention in evidence generation, yet its broader applications and the challenges it has been designed to address are not always well understood. Rather than replacing randomized controlled trials, the TTF provides a structured approach to observational studies, enabling the pre-specification of study design elements to clarify both strengths and limitations. Its flexibility supports use across a range of applications, from external control arms to comparative effectiveness and post-marketing studies, contributing to its growing adoption across the life sciences.
In this Evidence Insights, supported by Adigens Health, we bring together an infographic, expert interview, and accompanying article to explore how the TTF is being applied in practice, where it adds value across the lifecycle, and what is needed to use it effectively.
Infographic
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Infographic – Target practice: Making real‑world evidence credible through the As demand for robust real-world evidence grows, the TTF brings structure and credibility to observational research. View this infographic to learn more.
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Expert interview
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Video – How the target trial framework is shaping evidence generation: insights from Mona Khalid and Radek Wasiak, Adigens Health Mona Khalid and Radek Wasiak of Adigens Health speak with Laura Dormer, Editor of The Evidence Base, about how the TTF is being validated, where it adds value, and what is needed to apply it effectively in practice. |
Partner feature
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Partner feature – Two regulators, two data frameworks. One target trial specification Read more insights on how differences in US FDA and EMA approaches to real-world evidence feasibility shape evidence strategies, and how the TTF can help align study design across regulatory contexts. |
In association with
Sponsorship for this Evidence Insights was provided Adigens Health.