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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.
In this document
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Introduction to clinical trial strategies, phases of clinical development, and factors influencing success rates.
Focus on Phase I trials, including safety assessments, study designs, costs ($250K - $1.5M), and common issues.
Discussion of the TeGenero TGN1412 case, highlighting the importance of safe dosing and predictive models.
Overview of Phase II trial designs, effectiveness assessments, costs ($2M - $20M), and optimization strategies.
Details on Phase III trials, sample sizes (1,000 to 5,000), confirming efficacy, safety requirements, and costs ($20M - $100M).
Importance of a Clinical Development Plan (CDP) to minimize failures, enhance strategy, and ensure efficient drug development.
Key guidelines for establishing clinical development plans with timelines, costs, and importance of CROs.
