Design and Analysis of Platform Trials.

Lead Research Organisation: Lancaster University
Department Name: Mathematics and Statistics

Abstract

Bringing a new treatment to market is a long and expensive process, which can often end in failure. Platform trials are a class of clinical trials, which aim to increase efficacy compared to traditional trial designs via a possibility of adding new treatments to ongoing trials. Therefore, a statistical methodology for platform trials that allows new experimental treatments to be tested as efficiently as possible while satisfying the regulatory bodies' standards is essential. Therefore, STOR-i and Roche have partnered together in order to create a project which is focused on answering the following three questions:
1. When, why and how to add new treatments to an ongoing study?
2. How can a sequence of trials be designed?
3. How can a trial be best designed which has analyses conducted part way through the trial and where the trial focus is on comparing each treatment to one another?
The initial aim of the project is to develop methods that allow for the addition of new experimental treatments as the trial progresses. This is beneficial as during a course of confirmatory clinical trials - which can take years to run and require considerable resources - evidence for a new promising treatment may emerge. Therefore, it may be advantageous to include this treatment into the ongoing trial as this could benefit patients, funders and regulatory bodies by shortening the time taken comparing and selecting experimental treatments, thus allowing optimal therapies to be determined faster and reduce costs and patient numbers. The key part of the solution for this problem is making sure that the correct number of patients are recruited and that only treatments with enough evidence that they are better than the control treatment go on to the next phase, in order to meet regulatory bodies' standards. After studying this question, the methodology will then be further developed for the other two questions.

In partnership with Roche.

Publications

10 25 50

Studentship Projects

Project Reference Relationship Related To Start End Student Name
EP/S022252/1 01/10/2019 31/03/2028
2284198 Studentship EP/S022252/1 01/10/2019 30/09/2023 Peter Greenstreet