Video – How the target trial framework is shaping evidence generation: insights from Mona Khalid and Radek Wasiak of Adigens Health

Randomized trials remain the gold standard, but they can be impractical in urgent situations, ethically sensitive contexts, or when patient populations are limited. Increasingly, real-world data are being used to complement trial findings and to answer critical questions about treatment effectiveness and clinical practice. This shift calls for earlier and more strategic integration of real-world evidence into development plans. Approaches such as the target trial framework are helping to strengthen methodological rigor by structuring observational studies around trial-like protocols.

In this interview, Mona Khalid and Radek Wasiak of Adigens Health discuss how the target trial framework is being validated, where it adds the most value, and what is required to apply it effectively in practice.

Questions

• 00:00: Introduction
• 02:05: What is driving the shift toward earlier RWE planning in development, and what are the risks of waiting until Phase 3 to define a strategy?
• 04:44: Where do you see target trial emulation adding the most value across the development and evidence generation lifecycle, and how is it perceived by regulators and HTA decision-makers?
• 08:10: Even as technical understanding of TTE improves, applying it effectively often depends on strategic judgement. How can teams navigate the practical complexity of designing fit-for-purpose RWE when the optimal approach is highly context-dependent?
• 10:52: What have efforts to replicate randomized trials using TTE – and apply the method in real-world settings – shown so far, and what can we learn from examples where TTE has worked well or proved more challenging to implement?
• 14:43: Looking ahead, what are the most important steps to support broader and more confident use of TTE in decision-relevant evidence generation?
• 16:36: Finally, if there’s one message you’d like organizations to take away when thinking about applying TTE more strategically, what would it be?

Published as part of the Evidence Insights, "From trials to reality: Understanding the target trial framework in evidence generation".

Speakers

Mona Khalid, MSc
Co-Founder, Director, Adigens Health

Mona, a healthcare leader with expertise in portfolio strategy, evidence generation, and outcomes research, held executive roles across life sciences (in biopharma, biotech, and non-for-profit sectors). Her work focuses on improving access and patient outcomes, through early planning and robust analytical approaches. She was involved in building value-based data collection frameworks and launching blockbuster drugs.

Radek Wasiak, PhD
Co-Founder, Director, Adigens Health

Radek, an expert in real-world data assets and generation and real-world evidence, has provided research services to life sciences for more than two decades. His research spans real-world data assessment, outcome measurement and their real-world data applications. He held research and executive roles at top consulting and clinical-research organizations, driving innovation and team growth.

The opinions expressed in this feature are those of the author and do not necessarily reflect the views of The Evidence Base® or Becaris Publishing Ltd.

Published as part of the Evidence Insights, "From trials to reality: Understanding the target trial framework in evidence generation", sponsored by Adigens Health.