The Fourth Paradigm of clinical research: the innovation of clinical study management pattern in the era of biological big data / 中华医学科研管理杂志

ABSTRACT

Objective To explore the impact of biological big data on clinical study management.Methods To understand the changeof clinical study resulted from big data from the perspectiveof scientific study management.Results Bigdata Clinical Trial (BCT) based on massive clinical study data will turn out to be one of the most important parts of clinical study gradually.General rules target population will be obtained from clinical study model of the whole population.Reality fact will be more closely approached by the results of study on macro factors.Precise trend of dynamic changes can be demonstrated via data of full time linear tracking studies.Data collection will include those unordered data which are potentially inaccurate andregarded as useless in small data time.Conclusions Revolutionary changes will be presented in clinical study model in which data acquisition and info analysis are used as the primary approaches in big data era,and prediction of clinical study developmenttrend based on big data as well as innovation of management model for clinical study will make power ful support for better utilization of big data tools and accomplishment for big data realization and precision technology.