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Activity Number: 359 - Contributed Poster Presentations: Biopharmacutical Section
Type: Contributed
Date/Time: Tuesday, July 31, 2018 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #330508
Title: A Novel Approach of Using Prior Elicitation Information to Direct Design of a Phase 2 POC Study
Author(s): Geng Chen* and Jonathan Haddad
Companies: GlaxoSmithKline and Glaxosmithkline
Keywords: Bayesian design; prior elicitation; predictive inference

Bayesian analysis methods have been increasingly used in early phase clinical trial studies. They are widely accepted across therapeutic areas at GSK, including dermatology. Atopic dermatitis (AD) is an inflammatory disease of the skin. The IGA response rate was used as the primary endpoint. A proof-of-concept (POC) study was designed to estimate the probability that there is a true treatment effect of a GSK compound A compared to placebo. Prior elicitation is a well-documented methodology to quantify beliefs and uncertainty from experts which can be incorporated into trial design and can be useful when limited data exists to inform these estimates. A prior elicitation process was done around two questions: 1. whether the hypothesised mechanism of action is correct, and 2. If yes, what is the true treatment effect. Using the consensus prior, simulations were performed to estimate the probability of success under several scenarios. Interim futility rule and end of study success rule based on predictive probability were developed and successfully implemented. Benefits include more robust handling of uncertainty when little data exist and alignment of study team on beliefs.

Authors who are presenting talks have a * after their name.

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