Concept information
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Quality of Health Care
Health Care Evaluation Mechanisms
Evaluation Studies as Topic
Drug Approval
Preferred term
Compassionate Use Trials
Type
-
mesh:Descriptor
Definition
- Providing an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial, but who has a serious or life-threatening illness for which other treatments are not available. Compassionate use trials allow patients to receive promising but not yet fully studied or approved therapies when no other treatment option exists. Also called expanded access trial. FDA approved marketing and use of a device designed to diagnose or treat a disorder affecting fewer than 4,000 individuals annually. Treatment of seriously ill using unapproved techniques, devices, and substances.
Broader concept
Entry terms
- Expanded Access Trials
Allowable Qualifier(s)
- adverse effects (Qualifier)
- classification (Qualifier)
- economics (Qualifier)
- ethics (Qualifier)
- history (Qualifier)
- instrumentation (Qualifier)
- legislation & jurisprudence (Qualifier)
- methods (Qualifier)
- mortality (Qualifier)
- nursing (Qualifier)
- psychology (Qualifier)
- standards (Qualifier)
- statistics & numerical data (Qualifier)
- trends (Qualifier)
- veterinary (Qualifier)
In other languages
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French
-
Essais cliniques à accès élargi
-
Essais cliniques à accès étendu
-
Essais cliniques à usage humanitaire
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Essais cliniques pour un usage compassionnel
URI
http://data.loterre.fr/ark:/67375/JVR-K8L2B78B-R
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