About 70 percent of experimental drugs successfully pass this phase. One group receives the experimental drug, and the other, a control group, receives a placebo, or in the case of life-threatening disease, standard care. The trial may be blinded, with neither patients nor investigators aware of who is receiving the experimental drug. About one-third of the experimental drugs successfully pass through these first two phases. Randomized, blinded trials are held at multiple study sites and involve several hundred to several thousand patients.
Investigators evaluate efficacy, benefits and adverse reactions over an extended period of time.
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