国内药物临床试验方案撰写流程

Protocol Design Process of Domestic Drug Clinical Trial

要完成一项药物临床试验,设计一份科学、清晰、详尽的临床试验方案至关重要。临床试验数据是否真实可靠、临床试验数据收集是否完整准确、临床试验质量的好坏均与试验方案设计的科学性和合理性密切相关。临床试验方案设计的原则和每个步骤都要充分考虑试验的专业性和可操作性,以及试验完成后的统计分析,同时也应参考国际上相关规范或指南的要求,以利于与国际临床研究规范接轨。

The design of a scientific and detail drug clinical trial protocol is very crucial to completing a drug clinical trial.A scientific and rationality drug clinical trial protocol is also closely related to the reliability and accuracy of the data,and related to the quality of clinical trial.The profession and maneuverability,and the need of test after the completion of the statistical analysis should be considered to design principle and every step of the test , and the same time should also refer to the international rules or guidelines,to help with the international norms of clinical research.