Compassionate Use Trials (definition)

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ψ ψ	Compassionate Use Trials

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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.

Other names Use, Compassionate; Use Trials, Compassionate; Trials, Expanded Access; Trials, Compassionate Use; Trial, Expanded Access; Trial, Compassionate Use; Humanitarian Device Exemptions; Expanded Access Trial; Exemptions, Humanitarian Device; Exemption, Humanitarian Device; Device Exemptions, Humanitarian; Device Exemption, Humanitarian; Compassionate Uses; Compassionate Use Trial; Access Trial, Expanded; Humanitarian Device Exemption; Expanded Access Trials; Compassionate Use

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Sources: NLM Medical Subject Headings, NIH UMLS, Drugs@FDA, FDA AERS original data copyright United States Government. No endorsement implied. Last modified 6/6/2012
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