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.
Perspectives
The conceptual and statistical elegance of many adaptive designs in solving problems such as limited patient availability and unpredictable effect size and variance without sacrificing scientific validity is very appealing, but heighten the challenge of maintaining the clinician's perspective of what is good for the patient in balance with the scientist's perspective of what is good for the study or for the advancement of knowledge. As a physician, this is an ever-present context for clinical trials and especially those with adaptive designs.
Dr. Thomas A Laage
Premier Research Group Ltd
Read the Original
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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