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Ethical Considerations in Adaptive Design Clinical Trials.
Thomas Laage1, John W Loewy2, Sandeep Menon3
11 Premier Research Group Ltd, Philadelphia, PA, USA.
Therapeutic Innovation & Regulatory Science
|September 21, 2018
Summary
Adaptive trial designs present ethical challenges and opportunities. Careful planning and review ensure ethical principles are upheld in human subject research, balancing innovation with participant protection.
Area of Science:
- Clinical research methodology
- Bioethics
- Human subject protection
Background:
- Adaptive clinical trial designs offer flexibility but pose ethical considerations.
- Ethical principles like respect for persons, beneficence, and justice are central to human subject research.
Purpose of the Study:
- To review ethical obstacles and resolutions in adaptive design clinical trials.
- To examine how adaptive designs impact ethical principles in practice.
Main Methods:
- Review of published and unpublished adaptive design clinical trials.
- Analysis of case examples illustrating ethical challenges and successful resolutions.
Main Results:
- Adaptive designs can address ethical issues in confirmatory trials, interim analyses, sample size/dose adjustments, and adaptive randomization.
- Examples demonstrate successful navigation of ethical dilemmas concerning clinical equipoise, data monitoring, participant safety, and resource allocation.
- Platform, umbrella, and basket trials offer further efficiencies.
Conclusions:
- Adaptive design clinical trials require meticulous planning, rigorous ethical review, and case-by-case assessment.
- Careful implementation can uphold ethical standards while advancing research efficiency and participant well-being.
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