Updating the probability of study success for combination therapies using related combination study data.

ABSTRACT

Combination therapies are becoming increasingly used in a range of therapeutic areas such as oncology and infectious diseases, providing potential benefits such as minimising drug resistance and toxicity. Sets of combination studies may be related, for example, if they have at least one treatment in common and are used in the same indication. In this setting, value can be gained by sharing information between related combination studies. We present a framework that allows the study success probabilities of a set of related combination therapies to be updated based on the outcome of a single combination study. This allows us to incorporate both direct and indirect data on a combination therapy in the decision-making process for future studies. We also provide a robustification that accounts for the fact that the prior assumptions on the correlation structure of the set of combination therapies may be incorrect. We show how this framework can be used in practice and highlight the use of the study success probabilities in the planning of clinical studies.