Perspectives on Pooled Data Analysis: the Case for an Integrated Approach

[摘要] In the absence of definitive trials on the safety and efficacy of drugs, a systematic and careful synthesis of available data may provide critical information to help decision making by policy makers, medical professionals, patients and other stakeholders. However, uncritical and unbalanced use of pooled data to inform decision about important healthcare issues may have consequences that adversely impact public health, stifle innovation, and con found medical science. In this paper, we highlight current methodological issues and discuss advantages and disadvantages of alternative meta-analytic techniques. It is argued that results from pooled data analysis would have maximal reliability and usefulness in decision making if used in a holistic framework that includes presentation of data in light of all available knowledge and effective collaboration among academia, industry, regulatory bodies and other stakeholders.

[学科分类] 土木及结构工程学

[关键词] Drug safety assessment;heterogeneity;meta-analysis