Pooled solifenacin overactive bladder trial data: Creation, validation and analysis of an integrated database.

ABSTRACT:

Background

Patient-level data are available for 11 randomized, controlled, Phase III/Phase IV solifenacin clinical trials.

Methods

Meta-analyses were conducted to interrogate the data, to broaden knowledge about solifenacin and overactive bladder (OAB) in general. Before integrating data, datasets from individual studies were mapped to a single format using methodology developed by the Clinical Data Interchange Standards Consortium (CDISC). Initially, the data structure was harmonized, to ensure identical categorization, using the CDISC Study Data Tabulation Model (SDTM). To allow for patient level meta-analysis, data were integrated and mapped to analysis datasets. Mapping included adding derived and categorical variables and followed standards described as the Analysis Dat

SUBMITTER: Chapple CR 

PROVIDER: S-EPMC5935888 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature