Completed Psychology & Behaviour Brain & Nervous System

Adaptive Clinical Trials

In plain English

AI plain-English summary

Clinical trials are rewriting their own rulebooks as they run, rather than sticking to a rigid plan set before a single patient is enrolled. This matters because the traditional approach to designing a trial forces researchers to lock in assumptions—about how big a treatment effect will be, how many patients are needed, or what dose to use—before any data exist. If those assumptions are wrong, the trial can fail unnecessarily, wasting time and money, or exposing more patients than needed to an ineffective treatment. The problem is not a lack of good drugs, but a rigid testing system that can miss them. If this research succeeds, trials will become adaptive: they can stop early if a treatment is clearly working or clearly not, adjust the number of patients mid-study, change doses, or identify which patient subgroups respond best. The goal is to answer the same scientific questions with fewer patients, while maintaining statistical rigour. This could make drug development faster, cheaper, and more ethical—not by changing the drugs, but by changing how we test them.

View original technical description
Classically designing a clinical trial involves making assumptions about various attributes, such as the treatment effect, before any data are collected. The aim of our programme is to introduce novel designs that are more flexible. The rigidity of the classic design can lead to failed studies due to wrong assumptions such as using an optimistic treatment effect to limit the size of the study. Our novel designs will allow the use of accrued information in many ways; this includes stopping the study early for futility or efficacy, re-assessing the size of the study and recruiting more patients if need be altering dose choices during the study and identifying subgroups of patients who respond the best to treatment. Our overall goal is to minimise the number of people needed within a study whilst maintaining the statistical rigour needed to correctly answer the scientific questions.

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Researchers

Adrian Mander (Principal Investigator)

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Method - Design

Original classification

Intramural

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.