The Effective Statistician - in association with PSI RWE and JCA - how do they go together
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Apr 28, 2025 Katrin Kupas, a seasoned Director for Real-World Evidence with a decade of expertise in Health Technology Assessment, shares fascinating insights on integrating RWE with Joint Clinical Assessments. She emphasizes the importance of early evidence planning and when RCTs might fall short, making room for RWE. The conversation reveals the intricacies of indirect comparisons and the risks of non-randomized studies. Katrin also highlights the ROBINS-I tool for effective bias assessment, offering listeners actionable strategies to enhance their evidence generation plans.
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RWE Fills Comparator Data Gaps
- Real-world evidence (RWE) is crucial to fill data gaps when new drugs lack randomized trial comparators under JCA guidelines.
- RWE enables indirect treatment comparisons, especially for new drugs with many comparators but no direct RCT data.
Mitigate Bias in Non-Randomized Data
- Non-randomized comparisons carry more bias risks; focus on selecting data sources carefully to identify and adjust biases.
- Use robust statistical methods and quantify residual bias to strengthen the credibility of non-randomized analyses.
Plan RWE Early with Integration
- Start real-world evidence planning early with an integrated evidence plan to identify data gaps and answer clinical and HTA questions.
- Do not rely solely on clinical trials; incorporate RWE to cover gaps for medical and market access needs.
