ArticleAnnual review of statistics and its application2021
Adaptive Enrichment Designs in Clinical Trials.
Article in Annual review of statistics and its application, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Challenges and opportunities in biomarker-driven trials: adaptive randomization.Annals of translational medicine · 2022Trial
- Preclinical models of COPD: a state of the art review.The European respiratory journal · 2026Review
- Adaptive versus fixed designs in confirmatory clinical trials: centering the choice on ethics.Clinical trials (London, England) · 2026Article
- The Translational Paradox of Cancer Nanomedicine: Biological, Pharmacokinetic, and Manufacturing Barriers to Clinical Success.Biology · 2026Review
- Clinical trial endpoints for metabolic dysfunction and alcohol associated steatotic liver disease.Hepatology international · 2026Review
- Glutamatergic Modulators in Schizophrenia: Are We Ready to Move Beyond the Narrow Focus on Dopamine? A Potential Paradigm Shift in Psychopharmacology.Alpha psychiatry · 2026Article
- Efficient Testing Using Surrogate Information.Biometrical journal. Biometrische Zeitschrift · 2025Article
- Article
- Biomarker-guided adaptive enrichment design with threshold detection for clinical trials with time-to-event outcome.Journal of biopharmaceutical statistics · 2025Article
- Review
- Evidence-based personalised medicine in critical care: a framework for quantifying and applying individualised treatment effects in patients who are critically ill.The Lancet. Respiratory medicine · 2025Review
- A Novel Approach to Assess the Predictiveness of a Continuous Biomarker in Early Phases of Drug Development.Statistics in medicine · 2025Article
- Transforming Alzheimer's Treatment: Unveiling New Potential with Drug Repurposing Strategies.Current medicinal chemistry · 2025Review
- Gerontologic Biostatistics and Data Science: Aging Research in the Era of Big Data.The journals of gerontology. Series A, Biological sciences and medical sciences · 2024Review
- Use of Seamless Study Designs in Oncology Clinical Development- A Survey Conducted by IDSWG Oncology Sub-team.Therapeutic innovation & regulatory science · 2024Article
- Bayesian Sequential Design for Identifying and Ranking Effective Patient Subgroups in Precision Medicine in the Case of Counting Outcome Data with Inflated Zeros.Journal of personalized medicine · 2023Article
- Interpreting Randomized Controlled Trials.Cancers · 2023Review
- Point estimation for adaptive trial designs II: Practical considerations and guidance.Statistics in medicine · 2023Review
- Promising zone two-stage design for a single-arm study with binary outcome.Statistical methods in medical research · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
Abstract
Adaptive enrichment designs for clinical trials may include rules that use interim data to identify treatment-sensitive patient subgroups, select or compare treatments, or change entry criteria. A common setting is a trial to compare a new biologically targeted agent to standard therapy. An enrichment design's structure depends on its goals, how it accounts for patient heterogeneity and treatment effects, and practical constraints. This article first covers basic concepts, including treatment-biomarker interaction, precision medicine, selection bias, and sequentially adaptive decision making, and briefly describes some different types of enrichment. Numerical illustrations are provided for qualitatively different cases involving treatment-biomarker interactions. Reviews are given of adaptive signature designs; a Bayesian design that uses a random partition to identify treatment-sensitive biomarker subgroups and assign treatments; and designs that enrich superior treatment sample sizes overall or within subgroups, make subgroup-specific decisions, or include outcome-adaptive randomization.
Indexed as
Identifiers
What OpenQuestion holds
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.