Phase II stage of the clinical trials opens the doors for innovative designs. Phase II clinical trials are known as proof-of-concept-studies. They are conducted to study efficacy of the drug i.e. how well the prescribed dosage works on the particular group of patients. Two designs are developed to address the limitations of the phase II clinical trials. The first method drop-the-losers design helps to drop of inferior treatment groups and addition of new groups based on uncertainties in dose levels. The inferior group will drop out from the trial and the rest will proceed ahead to phase III trials.
The second design formulated to addresses objectives of phase II trials is known as Adaptive seamless phase design. This adaptive design includes two stages, learning stage and conformity
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