A quantitative benefit-risk assessment approach to improve decision making in drug development: Application of a multi-criteria decision analysis model in the development of combination therapy for overactive bladder

A multi-criteria decision analysis (MCDA) approach has been developed and used to estimate the benefit-risk of solifenacin and mirabegron and their combination in the treatment of OAB. The objectives were (1) to develop an MCDA tool to compare drug effects in OAB quantitatively, (2) to establish transparency in the evaluation of the benefit-risk profile of various dose combinations, and (3) to quantify the added value of combination use compared to monotherapies.

The MCDA model was developed using efficacy, safety and tolerability attributes and the results of a Phase 2 factorial design combination study were evaluated. Combinations of solifenacin 5 mg and mirabegron 25 mg and mirabegron 50 (5 + 25 and 5 + 50) scored the highest clinical utility and supported combination therapy development of solifenacin and mirabegron for Phase 3 clinical development at these dose regimens. This case study underlines the benefit of using a quantitative approach in clinical drug development programs. This article is protected by copyright. All rights reserved.

Clinical pharmacology and therapeutics. 2015 Sep 30 [Epub ahead of print]

Sandt I de Greef-van der, D Newgreen, M Schaddelee, C Dorrepaal, R Martina, A Ridder, R van Maanen

3D-PharmXchange B. V. , Maidstone 48a, 5026, SK, Tilburg, The Netherlands. , Astellas Pharma Europe B. V. , Sylviusweg 62, 2333, BE, Leiden, The Netherlands. , Astellas Pharma Europe B. V. , Sylviusweg 62, 2333, BE, Leiden, The Netherlands. , Astellas Pharma Europe B. V. , Sylviusweg 62, 2333, BE, Leiden, The Netherlands. , at Astellas Pharma Europe B. V. , Sylviusweg 62, 2333, BE, Leiden, The Netherlands. , Astellas Pharma Europe B. V. , Sylviusweg 62, 2333, BE, Leiden, The Netherlands. , Astellas Pharma Europe B. V. , Sylviusweg 62, 2333, BE, Leiden, The Netherlands.

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