
Designing a clinical trial to evaluate the efficacy of an intervention is often complicated by uncertainty over aspects of the study population, potential treatment effects, most relevant outcomes, dropouts, and other factors. However, once participants begin to be enrolled and partial trial data become available, this level of uncertainty is reduced. Adaptive clinical trials are designed to take advantage of the accumulating data during the conduct of a trial to make changes according to prespecified decision rules to increase the likelihood of success or statistical efficiency. Common adaptive rules address early stopping for benefit or futility, sample size reestimation, adding or dropping treatment arms or altering randomization ratios, and changing the eligibility criteria to focus on responder patient subgroups. Adaptive clinical trials are gaining popularity for clinical stroke research. We provide an overview of the methods, practical considerations, challenges and limitations, and potential future role of adaptive clinical trials in advancing knowledge and practice in stroke.
Cerebrovascular, Clinical Trials and Supportive Activities, anzsrc-for: 4201 Allied Health and Rehabilitation Science, 610, 32 Biomedical and Clinical Sciences, anzsrc-for: 1109 Neurosciences, anzsrc-for: 1103 Clinical Sciences, anzsrc-for: 32 Biomedical and Clinical Sciences, Clinical Research, anzsrc-for: 1102 Cardiorespiratory Medicine and Haematology, Humans, uncertainty, 3202 Clinical Sciences, 4201 Allied Health and Rehabilitation Science, anzsrc-for: 42 Health Sciences, Adaptive Clinical Trials as Topic, Neurosciences, 42 Health Sciences, Brain Disorders, Stroke, adaptive clinical trials, Research Design, 3209 Neurosciences, randomized controlled trials, anzsrc-for: 3209 Neurosciences, early termination of clinical trials, anzsrc-for: 3202 Clinical Sciences
Cerebrovascular, Clinical Trials and Supportive Activities, anzsrc-for: 4201 Allied Health and Rehabilitation Science, 610, 32 Biomedical and Clinical Sciences, anzsrc-for: 1109 Neurosciences, anzsrc-for: 1103 Clinical Sciences, anzsrc-for: 32 Biomedical and Clinical Sciences, Clinical Research, anzsrc-for: 1102 Cardiorespiratory Medicine and Haematology, Humans, uncertainty, 3202 Clinical Sciences, 4201 Allied Health and Rehabilitation Science, anzsrc-for: 42 Health Sciences, Adaptive Clinical Trials as Topic, Neurosciences, 42 Health Sciences, Brain Disorders, Stroke, adaptive clinical trials, Research Design, 3209 Neurosciences, randomized controlled trials, anzsrc-for: 3209 Neurosciences, early termination of clinical trials, anzsrc-for: 3202 Clinical Sciences
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