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Activity Number:
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300
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 2, 2016 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #319071
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View Presentation
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Title:
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Enhancing the Probability of Success Framework for Go/No-Go Decision Making Using ROC Curves
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Author(s):
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Alan Hartford* and Qi Tang and Deli Wang and Jyotirmoy Dey and Walt Offen and Frank Shen
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Companies:
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AbbVie and AbbVie and AbbVie and AbbVie and AbbVie and AbbVie
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Keywords:
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probability of success ;
ROC curves ;
go/no go decision
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Abstract:
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To make an informed Go/No Go decision for an investigational product, all available information should be effectively used to predict the results for ongoing and/or future clinical trials. This work is motivated by Broglio et al (2014 Trials), which presented an interesting application of assessing probability of success in a business acquisition case study involving a key oncology compound in phase 3 development. We propose a similar framework for Go/No Go decision making as Broglio where probability of success is still assessed utilizing all relevant information in a Bayesian way and sensitivity of probability of success is still examined against different choices of priors. However, the methodology is enhanced by including an evaluation of the risks associated with each decision made based using ROC curves. This enhancement of the methodology provides a quantitative approach to guide decision makers as to how high the probability of success should be to make a Go decision. A due diligence example is given to illustrate this enhanced framework.
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Authors who are presenting talks have a * after their name.
