国家神经系统疾病临床医学研究中心数据管理与共享系统

Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases

《国家中心数据管理与共享系统操作说明书 —— 研究者部分》

Working With Statisticians in Clinical Research

第一作者：Zixiao LI,Xianwei Wang

通讯作者：Yongjun Wang

Statisticians and Clinical Research

基本信息

2018-11-30

已发表文章

发表杂志：STROKE

发表类型: Original Contributions

影响因子(IF): 7.914

PMID: 30355217 Pubmed原文链接 全文下载

主要研究背景及目的

During the past several decades, stroke care delivery has been reshaped by the rise of clinical research studies in the fields of thrombolysis, endovascular therapy, and secondary prevention treatment. As such, statisticians play an important role in the successful conduct of clinical research.

方法

When developing a clinical research proposal, statisticians choosing primary outcomes, formulating primary study hypotheses based on the chosen outcomes, determining clinically significant differences, proposing a study design with the appropriate sample size and power calculations, writing prespecified statistical analysis plans, carrying out statistical analyses, interpreting results, and safeguarding the integrity and validity of the study when there is any modification of the protocol.

结论

In summary, teamwork between early clinical researchers and statisticians plays a key role in successfully formulating clinical research proposals and carrying out implementation.

主要结果

This article discuss topics that young clinical researchers and statisticians commonly encounter. Thus, establishing communication with a statistician early on in the research process and following up frequently will optimize study design and increase opportunities for investigators beginning a clinical research career.