ArticleBMC medicine2019
When to keep it simple - adaptive designs are not always useful.
Article in BMC medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 1 of them a synthesis that pooled it.
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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
44 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Design and analysis of umbrella trials: Where do we stand?Frontiers in medicine · 2022Pooled it
- Addition of Dendritic Cell Vaccination to Conditioning Cyclophosphamide and Chemoembolization in Patients with Hepatocellular Carcinoma: The ImmunoTACE Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Trial
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- Adaptive versus fixed designs in confirmatory clinical trials: centering the choice on ethics.Clinical trials (London, England) · 2026Article
- DOSET: dose optimization with simultaneous efficacy and toxicity evaluation, motivated by a first-in-human phase I CAR T lymphoma trial.ESMO open · 2026Article
- Adaptive trials in low back pain and osteoarthritis: How common are they and when should they be used? A systematic review from ClinicalTrials.gov.Osteoarthritis and cartilage open · 2026Review
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- Clinical Trial Simulation: Planning With the OCTAVE Framework, Implementation and Validation Principles.Statistics in medicine · 2026Article
- 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
- 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
- Impact of Endpoint Delay on the Efficiency of Multi Arm Multi Stage Trials.Statistics in medicine · 2025Article
- Platform trials: key features, when to use them and methodological challenges.The Medical journal of Australia · 2025Article
- Neuroprotective strategies in multiple sclerosis: a status update and emerging paradigms.Expert review of neurotherapeutics · 2025Review
- Barriers to publishing early phase clinical trials: the oncologists' perspective.The oncologist · 2025Article
- Review article: Primer for clinical researchers on innovative trial designs for emergency medicine.Emergency medicine Australasia : EMA · 2025Review
- Article
- Adaptive Trials in Stroke: Current Use and Future Directions.Neurology · 2024Review
- Adaptive clinical trials in surgery: A scoping review of methodological and reporting quality.PloS one · 2024Article
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Authors and funding
3 authors.
Funding
Abstract
backgroundAdaptive designs are a wide class of methods focused on improving the power, efficiency and participant benefit of clinical trials. They do this through allowing information gathered during the trial to be used to make changes in a statistically robust manner - the changes could include which treatment arms patients are enrolled to (e.g. dropping non-promising treatment arms), the allocation ratios, the target sample size or the enrolment criteria of the trial. Generally, we are enthusiastic about adaptive designs and advocate their use in many clinical situations. However, they are not always advantageous. In some situations, they provide little efficiency advantage or are even detrimental to the quality of information provided by the trial. In our experience, factors that reduce the efficiency of adaptive designs are routinely downplayed or ignored in methodological papers, which may lead researchers into believing they are more beneficial than they actually are. MAIN TEXT: In this paper, we discuss situations where adaptive designs may not be as useful, including situations when the outcomes take a long time to observe, when dropping arms early may cause issues and when increased practical complexity eliminates theoretical efficiency gains.
conclusionAdaptive designs often provide notable efficiency benefits. However, it is important for investigators to be aware that they do not always provide an advantage. There should always be careful consideration of the potential benefits and disadvantages of an adaptive design.
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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.