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About This Webinar
As the estimand framework becomes standard across clinical trials, “per-protocol” analyses are being re-examined for what they truly estimate and whether it is needed when the intercurrent event strategies address its elements. In this Bioforum webinar, we will explore why traditional per-protocol approaches do not support estimating the treatment effect that clinicians and regulators think it estimates, how adherence and intercurrent events reshape the question of treatment effect, and practical ways to align estimands, analysis strategies, and study objectives. Designed for sponsor teams responsible for statistical strategy, clinical development decisions, and regulatory readiness.
Agenda
- Estimand framework: why it matters and what has changed in practice
- Per-protocol: why it can be problematic (and where bias can creep in)
- Estimands and adherence: clarifying the scientific question and choosing an appropriate strategy
- Practical conclusions: how to approach “per-protocol” thinking in SAPs and regulatory discussions at the estimand era
When:
Thursday, February 26, 2026 · 9:00 a.m. · Eastern Time (US & Canada)
Duration: 1 hour
Language:
English
Who can attend? Everyone
Dial-in available?
(listen only): No
Featured Presenters
VP, Biostatistics Bioforum The Data Masters
Paul brings over 23 years of experience in planning and executing clinical trials, study designs, statistical analysis and reporting. He joins Bioforum from IQVIA, where he began his career as a statistician in 2003. Over the years, Paul held roles of increasing responsibility, moving up the ranks to serve as Country Manager for his Biostatistics and Statistical Programmer groups in South Africa. In addition, Paul led a major FSP program, overseeing the work of more than 235 biostatisticians and statistical programmers dedicated to a large, multinational pharmaceutical company. As the Vice President of Biostatistics, Paul drives the growth and expansion of Bioforum’s biostatistics capabilities and expertise, responsible for the FSP division and Bioforum Academy in the areas of biometrics and biostatistics. Certified by the South-African University of the Free State, Paul holds a M.Com. in Statistics. Paul is also a member of the South African Statistical Association.
Senior Biostatistician, Bioforum The Data Masters
Sivan Weiss obtained her MSc in Applied Statistics in 2004, after which she joined Teva Pharmaceuticals as a Biostatistician. During the next 12 years she worked on many studies that were part of submission programs until and following regulatory approval. On a technical level Sivan has applied several statistical methodologies on study data, including linear and non-linear models with mixed effects, Poisson regression, Negative Binomial regression, logistic regression, survival analysis, and power- and sample size calculations. Her experience spans phase 1, phase 2, phase 3 pivotal, and phase 4 post-marketing studies.
Sivan joined Bioforum in 2022 as a consulting statistician.
Sivan joined Bioforum in 2022 as a consulting statistician.
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