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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Remotely Supervised Transcranial Direct Current Stimulation: An Update on Safety and Tolerability
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Adaptive Trials in Stroke: Current Use and Future Directions.

Kathryn S Hayward1, Emily J Dalton1, Bruce C V Campbell1

  • 1From the Melbourne School of Health Sciences (K.S.H., E.J.D.), and Melbourne Medical School (K.S.H., H.J., L.C.), University of Melbourne, Parkville; Stroke Theme (K.S.H., B.C.V.C., J.B., L.C.), The Florey Institute, University of Melbourne, Heidelberg; National Health and Medical Research Council Centre of Research Excellence to Accelerate Stroke Trial Innovation and Translation (K.S.H., B.C.V.C., L.C., J.B., H.J.), University of Melbourne, Parkville; Department of Medicine and Neurology (B.C.V.C., V.Y.), Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia; Department of Neurology and Rehabilitation Medicine (P.K.), University of Cincinnati, OH; Department of Clinical Neuroscience (S.P.D.), and Hotchkiss Brain Institute (S.P.D.), University of Calgary, Alberta, Canada; Department of Neurology (S.W.), Saarland University, Saarbrücken; Department of Neurology (S.W.), Martin-Luther-University, Halle, Germany; Department of Neurology (V.Y.), University of Ottawa, Ontario, Canada; Department of Neurology (J.D.P.), Christian Medical College, Ludhiana, Punjab, India; Department of Biotechnological and Applied Clinical Sciences (S.S.), University of L'Aquila, Italy; Department of Neurology (M.W.P.), Liverpool Hospital, UNSW South Western Sydney Clinical School, Warwick Farm, Australia; Comprehensive Stroke Center and Department of Neurology (J.L.S.), University of California Los Angeles; and Australian Stroke Alliance (L.C.), University of Melbourne, Parkville, Victoria, Australia.

Neurology
|September 26, 2024
PubMed
Summary

Adaptive clinical trials offer flexible, efficient, and ethical research for neurological conditions like stroke. These innovative designs can be successfully implemented across various research questions in stroke and broader neurologic studies.

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Area of Science:

  • Neurology
  • Clinical Trial Design
  • Research Methodology

Background:

  • Adaptive trial designs incorporate pre-planned flexibility to modify clinical trials during conduct, maintaining validity and integrity.
  • Adaptive trials are crucial for accelerating efficient, informative, and ethical clinical research, particularly in neurology.
  • Stroke research is well-suited for adopting innovative adaptive trial designs.

Purpose of the Study:

  • To review adaptive clinical trials in stroke to assess the utility and impact of adaptive design features.
  • To discuss operational, ethical, and regulatory considerations for planning adaptive trials.
  • To evaluate workforce readiness for implementing adaptive trials in practice.

Main Methods:

  • A scoping review identified 45 completed or ongoing adaptive clinical trials in stroke.
  • Trials were categorized by publication status (results, protocol, registration).
  • Intervention types included acute, rehabilitation, and prevention phases of stroke.

Main Results:

  • The review identified 15 trials with published results and 30 ongoing trials.
  • Interventions covered acute (28), rehabilitation (8), and prevention (8) stages.
  • A subsample was analyzed to illustrate adaptive feature utility, usage, efficiencies, and learnings.

Conclusions:

  • Adaptive trials can be effectively designed, funded, conducted, and published for diverse stroke and neurologic research questions.
  • Successful implementation requires careful consideration of operational, ethical, and regulatory factors.
  • Future directions should focus on supporting the broader adoption of adaptive trial designs in neurologic research.