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Clinical and statistical issues in therapeutic equivalence trials
E Garbe1, J Röhmel, U Gundert-Remy
1Institut für Arzneimittel, Bundesgesundheitsamt, Berlin, Germany.
European Journal of Clinical Pharmacology
|January 1, 1993
Summary
Therapeutic equivalence trials are crucial for comparing drugs when effective treatments exist. Key protocol elements include defining the target parameter, selecting a superior reference drug, establishing an appropriate acceptance range, and using suitable statistical methods for robust evidence.
Area of Science:
- Clinical Pharmacology
- Biostatistics
- Drug Development
Background:
- Placebo-controlled trials offer absolute proof of efficacy.
- Ethical considerations necessitate demonstrating therapeutic equivalence when effective treatments are available.
- Classifying drugs within existing therapeutic alternatives is essential.
Purpose of the Study:
- To discuss critical components of therapeutic equivalence trial protocols.
- To highlight the differences between equivalence trials and placebo-controlled trials.
- To emphasize the importance of study conduct in establishing therapeutic equivalence.
Main Methods:
- Defining the target parameter (primary endpoint).
- Selecting a reference drug based on efficacy and safety data.
- Establishing an acceptance range relevant to clinical endpoints, not bioequivalence.
- Employing statistical procedures suitable for confirming equivalence, moving beyond conventional power approaches.
Main Results:
- Therapeutic equivalence trials require specific protocol definitions for accurate comparison.
- The conventional acceptance range for bioequivalence is not applicable to therapeutic equivalence.
- Statistical methods must be adapted to confirm equivalence rather than just efficacy.
Conclusions:
- High-quality study conduct, adhering to Good Clinical Practice, is paramount in equivalence trials.
- Equivalence trials provide essential data for drug classification and therapeutic decision-making.
- Demonstrating therapeutic equivalence relies heavily on meticulous trial execution and appropriate statistical analysis.