Clinical trial protocol design should ensure the rights and interests of subjects and ensure the scientificity of clinical trials. Quality comes from design, and the successful implementation of clinical trials comes from the integrity and accuracy of clinical trial protocol design, including the protection of the rights, safety and well-being of study subjects and scientific standards,such as the need to clarify pre-determined study objectives to solve major scientific problems; Selection appropriate subjects with the disease, condition or molecular/genetic profile being studied; Use methods that minimize bias, such as randomization, blinding or masking, and/or control confounding; Endpoints are clear and measurable, and the methods used to evaluate these endpoints are accurate and can be carried out with minimal reporting or measurement bias.
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