What is it about?
Adaptive designs for clinical trials have the potential to make research more efficient but also offer both opportunities and challenges for observing basic ethical principles in human subject research. We have provided examples of adaptive design trials that illustrate the ethical obstacles presented and often successfully resolved by these approaches.
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Why is it important?
Scientific knowledge in clinical medicine cannot advance without the altruistic participation of patients who agree at some risk to themselves to enroll in studies of experimental treatments. The research community owes these volunteers an explanation of their trial sufficient to make an informed judgment, a reasonable assurance of safety during their participation, and a valid scientific rationale for undertaking the study. Adaptive designs involve complexities that test the application of all three principles in ways that must be met and resolved.
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This page is a summary of: Ethical Considerations in Adaptive Design Clinical Trials, Therapeutic Innovation & Regulatory Science, March 2017, SAGE Publications,
DOI: 10.1177/2168479016667766.
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