ArticleBMC medicine2020
Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs.
Article in BMC medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07275307 (Evaluating the Effects of Prontosan Wound Gel X on the Occurrence of Superficial Surgical Site Infections in Adult Cardiac Surgery Patients), which is not on this map. Cited by 49 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.
Evaluating the Effects of Prontosan Wound Gel X on the Occurrence of Superficial Surgical Site Infections in Adult Cardiac Surgery Patients: A Single-Arm, Phase IV, Adaptive Feasibility Study
Who cites it
49 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Confidence Intervals for Adaptive Trial Designs I: A Methodological Review.Statistics in medicine · 2025Pooled it
- Brief Digital Interventions for Psychological Distress: An AI-Enhanced Response-Adaptive Randomized Clinical Trial.JAMA network open · 2025Trial
- Trial
- Global inequities in the adoption of innovative clinical trial designs: a cross-sectional analysis of ClinicalTrials.gov.BMJ open · 2026Observational
- Article
- Clinical Trial Simulation: Planning With the OCTAVE Framework, Implementation and Validation Principles.Statistics in medicine · 2026Article
- An efficient single-arm Bayesian adaptive trial algorithm to evaluate de-intensified oncologic treatment.Trials · 2025Article
- Alzheimer Combination Therapies: Overview and Scenarios.The journal of prevention of Alzheimer's disease · 2025Review
- Benefits of group sequential design and sample size re-estimation for randomised controlled trials evaluating the prevention of ventilator-associated pneumonia: a simulation study informed by real world data.BMC medical research methodology · 2025Article
- From Theory to Practice: Developing the MOBILE Intervention for Adults with Depression.Healthcare (Basel, Switzerland) · 2025Article
- A practical guide to simulation for an adaptive trial design with a single interim analysis.Trials · 2025Article
- Adaptive Biomarker-Based Design for Early Phase Clinical Trials.Statistics in medicine · 2025Article
- Practical guidance for conducting high-quality and rapid interim analyses in adaptive clinical trials.BMC medicine · 2025Review
- Response adaptive randomisation in clinical trials: Current practice, gaps and future directions.Statistical methods in medical research · 2025Article
- Evidence-Based Approaches to Quality Improvement: A Narrative Review of Integrating Bayesian Adaptive Trials Into Health Services.Journal of evaluation in clinical practice · 2025Review
- Confidence Intervals for Adaptive Trial Designs II: Case Study and Practical Guidance.Statistics in medicine · 2025Review
- Using circulating tumor DNA as a novel biomarker of efficacy for dose-finding designs in oncology.Statistical methods in medical research · 2025Article
- Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape.Small (Weinheim an der Bergstrasse, Germany) · 2025Review
- Clinical Trial Validity Guidance from the HTACG: Looking for Chicken Teeth.Journal of market access & health policy · 2025Article
- Re-envisioning clinical trial design in systemic sclerosis.Expert review of clinical immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
Adaptive designs for clinical trials permit alterations to a study in response to accumulating data in order to make trials more flexible, ethical, and efficient. These benefits are achieved while preserving the integrity and validity of the trial, through the pre-specification and proper adjustment for the possible alterations during the course of the trial. Despite much research in the statistical literature highlighting the potential advantages of adaptive designs over traditional fixed designs, the uptake of such methods in clinical research has been slow. One major reason for this is that different adaptations to trial designs, as well as their advantages and limitations, remain unfamiliar to large parts of the clinical community. The aim of this paper is to clarify where adaptive designs can be used to address specific questions of scientific interest; we introduce the main features of adaptive designs and commonly used terminology, highlighting their utility and pitfalls, and illustrate their use through case studies of adaptive trials ranging from early-phase dose escalation to confirmatory phase III studies.
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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.