临床科研项目样本量的要求

Requirements for Sample Size in Clinical Scientific Research Projects

目的规范临床研究方案中样本量估算依据,使研究设计更科学合理,以提高临床科研项目的研究质量。方法查阅国内有关临床科研项目样本量估算的文献进行讨论分析。结果结合伦理审查实践中所面临的关于样本量估算阐述不明、缺乏估算依据等问题,提出临床科研项目样本量估算的具体要求和解决样本量不合理的对策。结论规范临床科研项目的研究方案中样本量设计、加强教育培训和增强研究者意识。通过医学伦理委员会办公室工作人员提醒研究者样本量估算存在的常见问题,建议将统计学专家纳为委员或独立顾问,更好地审查临床科研项目涉及的样本量问题,提升临床科研项目的科学性和伦理性。

Objective: To standardize the basis of sample size estimation in clinical research protocol, so as to make the research design more scientific and rational, and to improve the quality of clinical scientific research projects. Methods: The domestic literatures on the sample size estimation of clinical scientific research projects were reviewed for discussion and analyzed. Results: Results in the light of the problems faced in the practice of ethical examination, such as unclear estimation of sample size and lack of basis for estimation, the specific requirements for estimating sample size of clinical scientific research items and the countermeasures to solve the unreasonable sample size were put forward. Combined with the problems faced in the practice of ethical review, such as the unclear explanation of sample size estimation and lack of estimation basis, they were put forward that the specific requirements and countermeasures of sample size estimation for clinical scientific research projects. Conclusions: To standardize the design of sample size, strengthen education and training, and enhance the awareness of researchers in clinical scientific research projects. To remind researchers of common problems in sample size estimation by the staff of the office of the medical ethics committee. To suggest that statistical experts should be included as members or independent consultants to better review the sample size issues involved in clinical research projects and enhance the scientific and ethical nature of clinical research projects.