Abstract
Phase 4 trials are conducted for a variety of reasons. These include investigating a marketed drug in pediatric patients, comparing a drug head-to-head with another drug, investigating the effect of a drug at a lower/higher dose or with different administration schedules, studying a drug in combination with other drugs, or testing a drug for other indications. In this chapter, we cover the design of Phase 4 trials from the perspective of obtaining a prior distribution for the treatment effect from past trials. We first focus on comparing different drugs in a network meta-analysis and proceed to consider a trial comparing a drug against a comparator using information obtained from the network meta-analysis. We also discuss how prior distributions for treatment effects may be obtained by other means such as PK/PD modeling.
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Chuang-Stein, C., Kirby, S. (2017). Designing Phase 4 Trials. In: Quantitative Decisions in Drug Development. Springer Series in Pharmaceutical Statistics. Springer, Cham. https://doi.org/10.1007/978-3-319-46076-5_10
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DOI: https://doi.org/10.1007/978-3-319-46076-5_10
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