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Pooled solifenacin overactive bladder trial data: Creation, validation and analysis of an integrated database.
Christopher R Chapple1, Linda Cardozo2, Robert Snijder3
1Department of Urology, Royal Hallamshire Hospital, Glossop Rd, Sheffield, South Yorkshire S10 2JF, UK.
Contemporary Clinical Trials Communications
|May 9, 2018
Summary
Meta-analyses of solifenacin clinical trials confirm consistent efficacy and safety data. Standardized data formats (CDISC SDTM and ADaM) enabled robust patient-level analysis for overactive bladder (OAB) treatments.
Area of Science:
- Pharmacology and Clinical Trial Data Analysis
- Overactive Bladder (OAB) Research
- Data Standardization in Clinical Research
Background:
- Utilized patient-level data from 11 randomized, controlled, Phase III/IV solifenacin clinical trials.
- Focused on broadening knowledge of solifenacin and overactive bladder (OAB).
Purpose of the Study:
- To conduct meta-analyses on solifenacin clinical trial data.
- To harmonize and integrate patient-level data for robust analysis.
Main Methods:
- Employed Clinical Data Interchange Standards Consortium (CDISC) methodology for data mapping and harmonization.
- Utilized Study Data Tabulation Model (SDTM) for data structure harmonization.
- Developed Analysis Data Model (ADaM) datasets for patient-level meta-analysis, including derived and categorical variables.
- Ensured data integrity through independent programming teams and cross-validation.
Main Results:
- Conducted three analysis groupings based on study design and dose (placebo-controlled, monotherapy, fixed/flexible-dose).
- Pooled data from up to 6539 solifenacin monotherapy patients.
- Confirmed patient similarity across groups, supporting data pooling for meta-analysis.
Conclusions:
- Validated Analysis Data Model (ADaM) datasets were created for medical history, efficacy, and adverse events (AEs).
- Meta-analysis results demonstrated consistency over time.
- Standardized data creation provided significant insights into individual studies and derivation decisions.
Keywords:
ADaM, Analysis Data ModelAE, adverse eventBMI, body mass indexCDISC, Clinical Data Interchange Standards ConsortiumCMH, Cochran-Mantel-HaenszelIDB, integrated databaseIntegrated databaseLOCF, last observation carried forwardMedDRA, Medical Dictionary for Regulatory ActivitiesOAB, overactive bladderPPIUS, Patient Perception of Urgency ScaleSDTM, Study Data Tabulation ModelSolifenacinTEAE, treatment emergent adverse eventValidation
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