SynthesisInternational urology and nephrology2018
Factors influencing efficacy endpoints in clinical trials for new oral medicinal treatments for overactive bladder: a systematic literature review and meta-analysis.
Synthesis in International urology and nephrology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeOveractive bladder (OAB) is a symptom-based disease; therefore, clinical trials to evaluate treatments for OAB employ a range of efficacy endpoints. Since factors that influence efficacy endpoints can affect trial outcomes, their identification could aid in the design of future OAB clinical trials. We investigated factors influencing different efficacy endpoints used in clinical trials with OAB patients and examined their characteristics to determine future clinical trial strategies for new medicinal treatments for OAB.
methodsData from placebo-controlled double-blind trials in patients with OAB were extracted via a systematic literature review. The integrated differences for efficacy endpoints were calculated. Heterogeneity was assessed using the Q statistic and I
resultsForty-one controlled trials were analyzed. Substantial heterogeneity between studies was observed for each efficacy endpoint (P > 0.001, I
conclusionsWe identified that change from baseline in the mean number of incontinence episodes in 24 h should serve as a relatively stable endpoint. In contrast, we identified factors influencing other endpoints, and the identified factors should be taken into account when planning and conducting future clinical trials.
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