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Multiple-dose phase I trials--normal volunteers or patients? One viewpoint
Journal of Clinical Pharmacology
|October 1, 1981
Summary
Phase I clinical trials traditionally use healthy volunteers for tolerance testing. This study questions the value of multiple-dose tolerance studies in healthy individuals, suggesting patient populations yield more relevant data.
Area of Science:
- Clinical pharmacology
- Drug development
Background:
- Phase I clinical trials are crucial for assessing drug safety and tolerance.
- Historically, normal healthy volunteers have been used for initial tolerance studies.
Purpose of the Study:
- To evaluate the established practice of using normal volunteers for multiple-dose tolerance studies in Phase I trials.
- To propose an alternative approach for generating more pertinent data in early-phase drug development.
Main Methods:
- Review of traditional Phase I trial methodologies.
- Conceptual analysis of data relevance based on study populations.
Main Results:
- The justification for multiple-dose tolerance studies in normal volunteers is questioned.
- Patient populations may provide more relevant data for tolerance assessment.
Conclusions:
- Re-evaluating the use of normal volunteers for multiple-dose tolerance studies is warranted.
- Utilizing appropriate patient populations in Phase I trials could enhance data pertinence.