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Activity Number:
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287
- Characterizing Clinical Dose Response Studies
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 1, 2017 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #322983
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Title:
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Clinical Dose-Response for a Broad Set of Biological Products: a Model-Based Meta-Analysis
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Author(s):
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Joseph Wu* and Anindita Banerjee and Bo Jin and Sandeep Menon and Steven W Martin and Anne C Heatherington
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Companies:
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Pfizer, Inc. and Pfizer, Inc. and Pfizer, Inc. and Pfizer, Inc and Pfizer, Inc. and Pfizer, Inc.
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Keywords:
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Biological products ;
Dose-response ;
Emax model ;
Meta-analysis ;
Bayesian
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Abstract:
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A model-based meta-analysis was conducted on the clinical efficacy of 71 distinct biologics evaluated in 91 placebo-controlled dose-response studies published between 1995 and 2014. The maximal effect model, arising from receptor occupancy theory, described the clinical dose-response data for the majority of the biologics (81.7%, n=58). Five biologics (7%) with data showing non-monotonic trend assuming the maximal effect model were identified and discussed. A Bayesian model-based hierarchical approach using different joint specifications of prior densities for the maximal effect model parameters was used to meta-analyze the whole set of biologics excluding these five biologics (n=66). Posterior predictive distributions of the maximal effect model parameters were reported and they could be used to aid the design of future dose-ranging studies. Compared to the meta-analysis of small molecules previously reported (Thomas et al, 2014), the combination of fewer doses, narrower dosing ranges, and small sample sizes further limited the information available to estimate clinical dose-response among biologics.
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Authors who are presenting talks have a * after their name.
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