Statistical Methods

Some uses of predictive probability of success in clinical drug development


Predictive probability of success is a (subjective) Bayesian evaluation of the prob- ability of a future successful event in a given state of information. In the context of pharmaceutical clinical drug development, successful events relate to the accrual of positive evidence on the therapy which is being developed, like demonstration of su- perior efficacy or ascertainment of safety. Positive evidence will usually be obtained via standard frequentist tools, according to the regulations imposed in the world of pharmaceutical development.
Within a single trial, predictive probability of success can be identified with expected power, i.e. the evaluation of the success probability of the trial. Success means, for example, obtaining a significant result of a standard superiority test.
Across trials, predictive probability of success can be the probability of a successful completion of an entire part of clinical development, for example a successful phase III development in the presence of phase II data.
Calculations of predictive probability of success in the presence of normal data with known variance will be illustrated, both for within-trial and across-trial predictions.

Full Text:





Article Metrics

Metrics Loading ...

Metrics powered by PLOS ALM


  • There are currently no refbacks.

Copyright (c)

We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it (Read more).

EBPH Epidemiology, Biostatistics and Public Health | ISSN 2282-0930

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.