Concept information
Preferred term
pivotal studies
Definition
- Pivotal studies are trials conducted after the early clinical development program establishes the overall efficacy and safety of the drug. These trials are an expansion of the clinical trials program. [Source: Encyclopedia of Health Care Management; Pivotal Studies]
Broader concept
Belongs to group
URI
https://concepts.sagepub.com/social-science/concept/pivotal_studies
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