ArticleStatistics in medicine2016
Unbiased estimation in seamless phase II/III trials with unequal treatment effect variances and hypothesis-driven selection rules.
Article in Statistics in medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed.
- Adjusting for treatment selection in phase II/III clinical trials with time to event data.Statistics in medicine · 2023Trial
- Conditional Estimations for Seamless Phase II/III Clinical Trials Involving Multi-Stage Early Stopping.Statistics in medicine · 2026Article
- Past, present, and future of Phase 3 vaccine trial design: rethinking statistics for the 21st century.Clinical and experimental immunology · 2025Review
- Point estimation following a two-stage group sequential trial.Statistical methods in medical research · 2023Article
- Point estimation for adaptive trial designs I: A methodological review.Statistics in medicine · 2023Review
- The benefits of covariate adjustment for adaptive multi-arm designs.Statistical methods in medical research · 2022Article
- Point and interval estimation in two-stage adaptive designs with time to event data and biomarker-driven subpopulation selection.Statistics in medicine · 2020Article
- Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19.Statistics in biopharmaceutical research · 2020Article
- Adaptive multiarm multistage clinical trials.Statistics in medicine · 2020Article
- Response adaptive randomization procedures in seamless phase II/III clinical trials.Journal of biopharmaceutical statistics · 2020Article
- Conditionally unbiased estimation in the normal setting with unknown variances.Communications in statistics: theory and methods · 2019Article
- Point estimation following two-stage adaptive threshold enrichment clinical trials.Statistics in medicine · 2018Article
- Estimation in multi-arm two-stage trials with treatment selection and time-to-event endpoint.Statistics in medicine · 2017Article
- Unbiased estimation in seamless phase II/III trials with unequal treatment effect variances and hypothesis-driven selection rules.Statistics in medicine · 2016Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
Seamless phase II/III clinical trials offer an efficient way to select an experimental treatment and perform confirmatory analysis within a single trial. However, combining the data from both stages in the final analysis can induce bias into the estimates of treatment effects. Methods for bias adjustment developed thus far have made restrictive assumptions about the design and selection rules followed. In order to address these shortcomings, we apply recent methodological advances to derive the uniformly minimum variance conditionally unbiased estimator for two-stage seamless phase II/III trials. Our framework allows for the precision of the treatment arm estimates to take arbitrary values, can be utilised for all treatments that are taken forward to phase III and is applicable when the decision to select or drop treatment arms is driven by a multiplicity-adjusted hypothesis testing procedure. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.