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Activity Number:
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607
- Effective Application of Modeling, Simulation and Knowledge Sharing in Drug Development
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 1, 2019 : 8:30 AM to 10:20 AM
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Sponsor:
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Statistics and Pharmacometrics Interest Group
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Abstract #306754
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Title:
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Trial Simulations to Support Proof of Concept Study Design: Application to Immunology
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Author(s):
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John Gibbs*
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Companies:
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AbbVie
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Keywords:
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pharmacokinetics;
pharmacodynamics;
meta-analysis;
clinical trial simulations;
immunology
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Abstract:
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In this presentation, the application of pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation will be discussed to inform the design of a proof-of-concept trial in immunology. A meta-analysis of existing therapies was used to identify the dose-response characteristics for monoclonal antibodies used to treat psoriasis. Based on the PK/PD properties of existing therapies and hypothetical cases, clinical trial simulations were conducted to evaluate the impact of trial design on the go/no go decision. A key design issue was whether to allocate patients to a single high dose cohort or to distribute patients across a range of doses better enabling the characterization of PK/PD properties. This case study will be discussed in more detail to enable deeper insights into collaborations between statisticians and pharmacometricians.
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Authors who are presenting talks have a * after their name.
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