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Some thoughts on clinical trials, especially problems of multiplicity
Science (New York, N.Y.)
|November 18, 1977
Summary
Ethical considerations and informed consent in clinical trials complicate experimental design, potentially preventing definitive answers to research questions. This can lead to alternative statistical approaches and designs.
Area of Science:
- Clinical research methodology
- Bioethics
- Experimental design
Background:
- Clinical trials face significant challenges in statistical and conceptual design.
- Ethical considerations, particularly informed consent, increasingly impact trial conduct.
Purpose of the Study:
- To explore the complex interplay between ethical issues and experimental design in clinical trials.
- To discuss the implications of ethical constraints on the ability to answer research questions definitively.
Main Methods:
- Conceptual analysis of ethical principles in clinical trial design.
- Review of potential consequences for statistical methodologies and experimental approaches.
Main Results:
- Ethical requirements, such as informed consent, pose significant hurdles to obtaining clear, quantitative evidence of effectiveness.
- These ethical constraints may necessitate the use of alternative or modified experimental designs.
Conclusions:
- Ethical imperatives in clinical trials create inherent difficulties in experimental design and data interpretation.
- Strategies like unbalanced boundaries, focusing-down designs, and historical controls may arise as consequences of these ethical and regulatory demands.
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