Estimands in Clinical Trials: Why Taiwan's 2026 Adoption Signals the Framework Has Gone Global
On April 14, 2026, the Taiwan Food and Drug Administration formally adopted the ICH E9(R1) addendum on estimands and sensitivity analysis as guidance for drug clinical trial review. Seven years after the framework's original release, this is not a footnote — it confirms a pattern already visible at FDA, EMA, and China's NMPA: regulators worldwide now expect trial teams to define precisely what treatment effect a study is estimating before a single patient is randomised. The implementation gap, in other words, hasn't closed. It has simply moved to more jurisdictions at once.
Estimands in Clinical Trials: A Practical Guide (Springer, January 2026) was built for exactly this moment.
Who Wrote It and Why It Matters
Jiawei Wei (Senior Director Biostatistician at Novartis, Advanced Methodology and Data Science) and Frank Bretz (Distinguished Quantitative Research Scientist at Novartis and ICH E9(R1) Expert Working Group member) bring direct experience from developing and operationalising the framework itself. Leslie Meng (Boehringer Ingelheim) contributes from large-scale drug development across therapeutic areas. Feng Chen (Nanjing Medical University, Chair of China Clinical Trial Statistics Working Group) and Jun Wang (Center for Drug Evaluation, NMPA) ensure the regulatory perspective covers Asia-Pacific as fully as the FDA and EMA.
Three Ways This Book Gets Used on the Desk
- Translating the five ICH E9(R1) intercurrent event strategies into concrete protocol and statistical analysis plan language, with worked case studies across oncology, neurology, cardiology, and diabetes
- Selecting a missing-data and sensitivity-analysis approach that stays aligned with the target estimand, across continuous, binary, recurrent, and time-to-event endpoints
- Applying the framework to adaptive designs, master protocols, non-inferiority trials, multiregional trials, and decentralised clinical trials — settings the original 2019 guidance did not fully anticipate
For Pharmaceutical and Medical Libraries
As more regulators adopt the framework, biostatistics and regulatory affairs teams need a single reference that covers FDA, EMA, and NMPA expectations without forcing them to reconcile three separate literatures. This book is that reference — a candidate for any collection supporting drug development, clinical research, or regulatory science.
Q&A
What is the ICH E9(R1) estimand framework?
A structured methodology requiring clinical trial teams to precisely define the treatment effect they intend to estimate — including the population, endpoint, intercurrent event strategies, and population-level summary — before making design and analysis decisions.
Which regulators now expect estimands in submissions?
FDA and EMA have applied the framework since 2019; China's NMPA has been accelerating adoption; and as of April 2026, Taiwan's TFDA has formally adopted ICH E9(R1) as review guidance, reflecting the framework's continued spread across ICH-aligned jurisdictions.
What are intercurrent events and why do they matter?
Post-randomisation occurrences — such as treatment discontinuation, rescue medication use, or death — that affect the interpretation or existence of the endpoint. How they're handled determines what treatment effect is actually being estimated. The book covers all five ICH E9(R1) strategies with case studies.
Is this book relevant for regulatory affairs teams, not just statisticians?
Yes. Part III addresses regulatory guidance content from FDA, EMA, and NMPA perspectives, making it directly relevant for professionals preparing or reviewing submissions.
Where can pharmaceutical and medical libraries order this title?
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