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Sample Size and Power

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Phase II Designs<br />

• Screening of new therapies<br />

• Not to prove ‘final’ efficacy, usually<br />

– Efficacy based on surrogate outcome<br />

• Sufficient activity to be tested in a<br />

r<strong>and</strong>omized study<br />

• Issues of safety still important<br />

• Small number of patients (still may be<br />

in the hundreds total, but maybe less<br />

than 100/arm)

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