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Clinical Trials Strategy: The Clinical Development Plan
The document discusses key aspects of clinical trial strategy and design. It covers the different phases of clinical trials (Phase I, II, III) and provides guidance on optimizing trials at each phase. Phase I focuses on safety and dosing, Phase II evaluates efficacy and further safety, and Phase III confirms efficacy in a larger patient population. The document emphasizes establishing a detailed clinical development plan with timelines and costs to help guide development decisions and reduce risks.
