exploratory studies
- Guideline or reference source
- FDAPNG Patient network glossary terms
- Definition
- Studies that are not A&WC, often because they do not rigorously control the Type I error rate or because they use an endpoint that is not suitable to be a basis of marketing approval. Exploratory studies are generally conducted earlier in the drug development program than the A&WC studies and have an important informative role in drug development concerning future choices for A&WC study population and endpoints.
- Related Term
- adequate and well controlled trial
- endpoint
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