What are the benefits of including external data in the design and analysis of clinical studies?
How does the meta-analytic predictive model (MAP) work?
Boosting clinical trial data with external data belongs to the very hot topics at the moment. Every conference includes a session about it and many webinars present about it. I’m very happy to have an expert in this area on the show – Gaëlle Saint-Hilary. Learn, when is it appropriate to use historical data and when is it appropriate to enrol new patients to collect new data.
Gaëlle and I talked about the various topics around using historical data in clinical trials:
- What is dynamic borrowing?
- What are the impacts on sample size and effective sample size?
- How do we best make decisions based on the final results?
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Gaëlle Saint-Hilary
CEO, Statistical Methodologist at Saryga
Gaëlle Saint-Hilary is Statistical Methodologist, CEO and founder of the consulting company Saryga (France). Before this role, Gaëlle was Statistical Methodologist at Servier until December 2021. With more than 15 years of experience in the pharmaceutical industry (Servier, Novartis) and a strong and long-lasting collaboration with academia, Gaëlle Saint-Hilary is an expert in Bayesian statistics and decision-making support. She has worked at developing novel approaches to improve drug development’s performances, and her main scientific interests are quantitative decision-making, benefit-risk assessment, innovative study designs and historical data.
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