Pooled solifenacin overactive bladder trial data: Creation, validation and analysis of an integrated database
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...
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doaj-be3acbb5e4914177a86c975dd5aea4362020-11-24T21:44:56ZengElsevierContemporary Clinical Trials Communications2451-86542016-12-014C19920710.1016/j.conctc.2016.10.003Pooled solifenacin overactive bladder trial data: Creation, validation and analysis of an integrated databaseChristopher R. Chapple0Linda Cardozo1Robert Snijder2Emad Siddiqui3Sender Herschorn4Department of Urology, Royal Hallamshire Hospital, Glossop Rd, Sheffield, South Yorkshire S10 2JF, UKKing's College Hospital, Denmark Hill, London, SE5 9RS, UKAstellas Pharma Europe BV, Sylviusweg 62, 2333 BE, Leiden, The NetherlandsAstellas Pharma Europe Ltd, 2000 Hillswood Dr, Chertsey, Surrey KT16 0PS, CanadaDepartment of Surgery/Urology, University of Toronto, 27 King's College Cir, Toronto, Ontario ON M5S, CanadaBackground: 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 Data Model (ADaM). Mapping to both SDTM and ADaM was performed twice by two independent programming teams, results compared, and inconsistencies corrected in the final output. ADaM analysis sets included assignments of patients to the Safety Analysis Set and the Full Analysis Set. Results: There were three analysis groupings: Analysis group 1 (placebo-controlled, monotherapy, fixed-dose studies, n = 3011); Analysis group 2 (placebo-controlled, monotherapy, pooled, fixed- and flexible-dose, n = 5379); Analysis group 3 (all solifenacin monotherapy-treated patients, n = 6539). Treatment groups were: solifenacin 5 mg fixed dose, solifenacin 5/10 mg flexible dose, solifenacin 10 mg fixed dose and overall solifenacin. Patient were similar enough for data pooling to be acceptable. Conclusions: Creating ADaM datasets provided significant information about individual studies and the derivation decisions made in each study; validated ADaM datasets now exist for medical history, efficacy and AEs. Results from these meta-analyses were similar over time.http://www.sciencedirect.com/science/article/pii/S245186541630062XIntegrated databaseSolifenacinValidation |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Christopher R. Chapple Linda Cardozo Robert Snijder Emad Siddiqui Sender Herschorn |
spellingShingle |
Christopher R. Chapple Linda Cardozo Robert Snijder Emad Siddiqui Sender Herschorn Pooled solifenacin overactive bladder trial data: Creation, validation and analysis of an integrated database Contemporary Clinical Trials Communications Integrated database Solifenacin Validation |
author_facet |
Christopher R. Chapple Linda Cardozo Robert Snijder Emad Siddiqui Sender Herschorn |
author_sort |
Christopher R. Chapple |
title |
Pooled solifenacin overactive bladder trial data: Creation, validation and analysis of an integrated database |
title_short |
Pooled solifenacin overactive bladder trial data: Creation, validation and analysis of an integrated database |
title_full |
Pooled solifenacin overactive bladder trial data: Creation, validation and analysis of an integrated database |
title_fullStr |
Pooled solifenacin overactive bladder trial data: Creation, validation and analysis of an integrated database |
title_full_unstemmed |
Pooled solifenacin overactive bladder trial data: Creation, validation and analysis of an integrated database |
title_sort |
pooled solifenacin overactive bladder trial data: creation, validation and analysis of an integrated database |
publisher |
Elsevier |
series |
Contemporary Clinical Trials Communications |
issn |
2451-8654 |
publishDate |
2016-12-01 |
description |
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 Data Model (ADaM). Mapping to both SDTM and ADaM was performed twice by two independent programming teams, results compared, and inconsistencies corrected in the final output. ADaM analysis sets included assignments of patients to the Safety Analysis Set and the Full Analysis Set.
Results: There were three analysis groupings: Analysis group 1 (placebo-controlled, monotherapy, fixed-dose studies, n = 3011); Analysis group 2 (placebo-controlled, monotherapy, pooled, fixed- and flexible-dose, n = 5379); Analysis group 3 (all solifenacin monotherapy-treated patients, n = 6539). Treatment groups were: solifenacin 5 mg fixed dose, solifenacin 5/10 mg flexible dose, solifenacin 10 mg fixed dose and overall solifenacin. Patient were similar enough for data pooling to be acceptable.
Conclusions: Creating ADaM datasets provided significant information about individual studies and the derivation decisions made in each study; validated ADaM datasets now exist for medical history, efficacy and AEs. Results from these meta-analyses were similar over time. |
topic |
Integrated database Solifenacin Validation |
url |
http://www.sciencedirect.com/science/article/pii/S245186541630062X |
work_keys_str_mv |
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