Estimands and Complex Innovative Designs
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2575
Abstract: Since the release of the ICH E9(R1) (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for… read more here.
Keywords: innovative designs; complex innovative; estimand framework; trial ... See more keywords
Application of estimand framework in ICH E9 (R1) to vaccine trials.
Sign Up to like & getrecommendations! Published in 2023 at "Journal of biopharmaceutical statistics"
DOI: 10.1080/10543406.2023.2197040
Abstract: Over the past decades, the primary interest in vaccine efficacy or immunogenicity evaluation mostly focuses on the biological effect of immunization in complying with the vaccination schedule in a targeted population. The safety questions, which… read more here.
Keywords: application estimand; framework; ich vaccine; estimand framework ... See more keywords
Application of estimand framework to the design and analysis of multi-regional clinical trials
Sign Up to like & getrecommendations! Published in 2024 at "Journal of Biopharmaceutical Statistics"
DOI: 10.1080/10543406.2024.2362736
Abstract: ABSTRACT With the increasing globalization of drug development and the publication of the International Council for Harmonisation (ICH) E17 guideline (ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use 2017), multi-regional… read more here.
Keywords: estimand framework; multi regional; application estimand; framework ... See more keywords
Estimand Framework in AML Based on a Randomized, Placebo-Controlled, Phase 3 Study Investigating the Effect of Adding Midostaurin to Standard Chemotherapy in Patients with Newly Diagnosed AML without a FLT3 Mutation
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DOI: 10.1182/blood-2018-99-119394
Abstract: In the ongoing randomized, placebo-controlled, phase 3 study in patients with newly diagnosed FLT3-mutation-negative acute myeloid leukemia (AML; NCT03512197) investigating the effect of adding midostaurin to standard chemotherapy, event-free survival (EFS) is the primary endpoint.… read more here.
Keywords: estimand framework; treatment; effect; flt3 mutation ... See more keywords
Realizing the benefits of the estimand framework when reporting and communicating clinical trial results—some recommendations
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DOI: 10.1186/s13063-025-08915-6
Abstract: Reports of the results of clinical studies are integral to regulatory decision making. They are used to support marketing authorization, to substantiate labeling information, and to inform academic publications, trial postings, and promotional messages intended… read more here.
Keywords: estimand framework; framework; framework reporting; trial ... See more keywords