phase 2 = moderate number of patents with the disease of interest. Assesses treatment efficacy, optimal dosing, and adverse effects.
phase 3 = LARGE number of patients randomly assigned to either treatment group or the standers of care . Compares the new treatment to the current standard of care to see if there is any improvement.
FA19 p 256
submitted by ∗lfsuarez(160)
Phase II studies test the efficacy of a drug. This second phase of testing can last from several months to two years, and involves up to several hundred affected patients.