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With the continued increase in the use of Bayesian methods in drugdevelopment, there is a need for statisticians to have tools to develop robustand defensible informative prior distributions. Whilst relevant empirical datashould, where possible, provide the basis for such priors, it is often the casethat limitations in data and/or our understanding may preclude directconstruction of a data-based prior. Formal expert elicitation methods are a keytechnique that can be used to determine priors in these situations. WithinGlaxoSmithKline (GSK), we have adopted a structured approach to priorelicitation based on the SHELF elicitation framework, and routinely use this inconjunction with calculation of probability of success (assurance) of the nextstudy(s) to inform internal decision making at key project milestones. The aimof this paper is to share our experiences of embedding the use of priorelicitation within a large pharmaceutical company, highlighting both thebenefits and challenges of prior elicitation through a series of case studies.We have found that putting team beliefs into the shape of a quantitativeprobability distribution provides a firm anchor for all internal decisionmaking, enabling teams to provide investment boards with formally appropriateestimates of the probability of trial success as well as robust plans forinterim decision rules where appropriate. As an added benefit, the elicitationprocess provides transparency about the beliefs and risks of the potentialmedicine, ultimately enabling better portfolio and company-wide decisionmaking.

Better Decision Making in Drug Development Through Adoption of Formal Prior Elicitation