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

Working With Statisticians in Clinical Research

First author:Zixiao LI,Xianwei Wang

Corresponding author:Yongjun Wang

Statisticians and Clinical Research

essential_information

2018-11-30

Published articles

Journal:STROKE

Publication type: Original Contributions

IF(IF): 7.914

PMID: 30355217 Link To Pubmed Full text Download

Background And Purpose

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.

Method

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.

Conclusion

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

Main results

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.