Business case studies
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Innovative Trial Design
Design a patient-centric trial & avoid a demonstration of "non-inferiority"
Investigators needed to lower the dose (to reduce toxicity & improve compliance) without loss of efficacy. Using a conventional trial design to prove non-inferiority had an original sample size of 700 patients.
Using the GPC methodology to include both efficacy and safety criteria to assess the net treatment benefit of the reduced dose, made the trial feasible by reducing the required sample size to only 280 patients.
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