ArticleBMC medical ethics2015
Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis.
Article in BMC medical ethics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 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
24 citing papers in PubMed.
- Feasibility and adherence to moderate intensity cardiovascular fitness training following stroke: a pilot randomized controlled trial.BMC neurology · 2021Trial
- Bayesian dose selection design for a binary outcome using restricted response adaptive randomization.Trials · 2017Trial
- Adaptive versus fixed designs in confirmatory clinical trials: centering the choice on ethics.Clinical trials (London, England) · 2026Article
- Uncertainty and novel clinical trial designs in oncology - when should equipoise matter?Clinical trials (London, England) · 2026Article
- Considerations raised during the regulatory and ethics review of platform clinical trials in infectious diseases.Contemporary clinical trials communications · 2026Article
- Bayesian adaptive randomization in the I-SPY2 sequential multiple assignment randomized trial.Biometrics · 2026Article
- Research ethics and integrity challenges in accelerated clinical trials, an interview study.BMC medical ethics · 2025Article
- Mixed methods research: A primer for the vascular surgeon.Seminars in vascular surgery · 2022Review
- Advance Care Planning Experiences Among Sexual and Gender Minority People.JAMA network open · 2022Article
- Article
- How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis.Trials · 2020Article
- When to keep it simple - adaptive designs are not always useful.BMC medicine · 2019Article
- Outcome-adaptive randomization in clinical trials: issues of participant welfare and autonomy.Theoretical medicine and bioethics · 2019Article
- Critical concepts in adaptive clinical trials.Clinical epidemiology · 2018Review
- 'Recover quicker, train harder, and increase flexibility': massage therapy for elite paracyclists, a mixed-methods study.BMJ open sport & exercise medicine · 2018Article
- A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network.Clinical trials (London, England) · 2017Article
- Article
- PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms.Clinical pharmacology and therapeutics · 2016Article
- Article
- Integrating Quantitative and Qualitative Results in Health Science Mixed Methods Research Through Joint Displays.Annals of family medicine · 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
8 authors.
Funding
Abstract
backgroundIn an adaptive clinical trial (ACT), key trial characteristics may be altered during the course of the trial according to predefined rules in response to information that accumulates within the trial itself. In addition to having distinguishing scientific features, adaptive trials also may involve ethical considerations that differ from more traditional randomized trials. Better understanding of clinical trial experts' views about the ethical aspects of adaptive designs could assist those planning ACTs. Our aim was to elucidate the opinions of clinical trial experts regarding their beliefs about ethical aspects of ACTs.
methodsWe used a convergent, mixed-methods design employing a 22-item ACTs beliefs survey with visual analog scales and open-ended questions and mini-focus groups. We developed a coding scheme to conduct thematic searches of textual data, depicted responses to visual analog scales on box-plot diagrams, and integrated findings thematically. Fifty-three clinical trial experts from four constituent groups participated: academic biostatisticians (n = 5); consultant biostatisticians (n = 6); academic clinicians (n = 22); and other stakeholders including patient advocacy, National Institutes of Health, and U.S. Food and Drug Administration representatives (n = 20).
resultsThe respondents recognized potential ethical benefits of ACTs, including a higher probability of receiving an effective intervention for participants, optimizing resource utilization, and accelerating treatment discovery. Ethical challenges voiced include developing procedures so trial participants can make informed decisions about taking part in ACTs and plausible, though unlikely risks of research personnel altering enrollment patterns.
conclusionsClinical trial experts recognize ethical advantages but also pose potential ethical challenges of ACTs. The four constituencies differ in their weighing of ACT ethical considerations based on their professional vantage points. These data suggest further discussion about the ethics of ACTs is needed to facilitate ACT planning, design and conduct, and ultimately better allow planners to weigh ethical implications of competing trial designs.
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.