clinical trial

/ˌklɪnəkəl ˌtraɪ(ə)l/

Other forms: clinical trials

Definitions of clinical trial

1. noun

   a rigorously controlled test of a new drug or a new invasive medical device on human subjects; in the United States it is conducted under the direction of the FDA before being made available for general clinical use
   synonyms: clinical test

   types:

   phase I, phase I clinical trial

   a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained

   phase II, phase II clinical trial

   a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored

   phase III, phase III clinical trial

   a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA

   phase IV, phase IV clinical trial

   sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier trials

   type of:

   run, test, trial

   the act of testing something