Trial reportContemporary clinical trials2014
Adaptive choice of patient subgroup for comparing two treatments.
Trial report in Contemporary clinical trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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
12 citing papers in PubMed.
- Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging.The New England journal of medicine · 2018Trial
- A multicenter randomized controlled trial of endovascular therapy following imaging evaluation for ischemic stroke (DEFUSE 3).International journal of stroke : official journal of the International Stroke Society · 2017Trial
- Evaluation of a multi-arm multi-stage Bayesian design for phase II drug selection trials - an example in hemato-oncology.BMC medical research methodology · 2016Trial
- Inference on subgroups identified based on a heterogeneous treatment effect in a post hoc analysis of a clinical trial.Clinical trials (London, England) · 2023Article
- IBIS: identify biomarker-based subgroups with a Bayesian enrichment design for targeted combination therapy.BMC medical research methodology · 2023Article
- A two-stage adaptive clinical trial design with data-driven subgroup identification at interim analysis.Pharmaceutical statistics · 2022Article
- Design and analysis of biomarker-integrated clinical trials with adaptive threshold detection and flexible patient enrichment.Journal of biopharmaceutical statistics · 2020Article
- Multi-stage adaptive enrichment trial design with subgroup estimation.Journal of biopharmaceutical statistics · 2020Article
- The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations.Journal of biopharmaceutical statistics · 2020Article
- Estimating the subgroup and testing for treatment effect in a post-hoc analysis of a clinical trial with a biomarker.Journal of biopharmaceutical statistics · 2019Article
- Article
- Adaptive design of confirmatory trials: Advances and challenges.Contemporary clinical trials · 2015Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
This paper is motivated by a randomized controlled trial to compare an endovascular procedure with conventional medical treatment for stroke patients, in which the endovascular procedure may be effective only in a subgroup of patients. Since the subgroup is not known at the design stage but can be learned statistically from the data collected during the course of the trial, we develop a novel group sequential design that incorporates adaptive choice of the patient subgroup among several possibilities which include the entire patient population as a choice. We define the type I and type II errors of a test in this design and show how a prescribed type I error can be maintained by using the closed testing principle in multiple testing. We also show how asymptotically optimal tests can be constructed by using generalized likelihood ratio statistics for parametric problems and analogous standardized or Studentized statistics for nonparametric tests such as Wilcoxon's rank sum test commonly used for treatment comparison in stroke patients.
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.