UNIT 3: Clinical Trial Design and Methodology
This unit explains how clinical trials are scientifically designed to generate valid, unbiased, and meaningful results that can be applied to real-world medical practice. It covers core design principles, randomization methods, blinding, endpoints, and operational tools used during trial execution.
In clinical research, the aim of trial design is to derive valid and meaningful scientific conclusions using appropriate methodologies that can be translated to real-world clinical settings. A well-designed study minimizes bias, controls variability, and ensures ethical conduct while answering the research question.
Key Points
Design must align with study objectives
Scientific validity and ethical acceptability are essential
Poor design can invalidate trial outcomes
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