SOLVE: Assessing Overall Survival - Can We do it better? V7
Research type
Research Study
Full title
The analysis of overall survival in a changing clinical world; the methodological implications of relapsing cancers in randomised controlled trials.
IRAS ID
299766
Contact name
Kara-Louise Royle
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
In a cancer clinical trial the length of time from randomisation to death, referred to as overall survival, is a way to evaluate how a new treatment performs. However, not all cancers can be controlled with one type or ‘line’ of treatment. After a period of disease control, the cancer may start to grow again (progress) and a new line of treatment is needed. In this case participants usually stop their trial treatment and may start a different treatment. This different treatment is no longer determined by the clinical trial.
This means that instead of having one type of anti-cancer treatment in the period in which overall survival is assessed, participants can have many types of treatment. This makes it difficult to work out what effect each line of treatment has on overall survival and in turn evaluate the new treatment in the clinical trial.
This study will investigate methods that can be used to analyse overall survival in the event that some participants receive anti-cancer treatment post-trial and aims to develop a method which appropriately assesses overall survival in this scenario.
However, for new method to be relevant, stakeholders (including patients, clinicians and statisticians) will be asked to complete a questionnaire to aid discussions and identify the study’s main priorities in terms of how to analyse overall survival, and how to present the results. Once developed, the new method will be tested on simulated (computer generated) and clinical trial data. It will then be assessed by those who participated in the initial discussions and updated where appropriate. The practicality and accessibility of the method will then be considered by writing statistical software, exploring how researchers could access the required data for the new and existing methods through routine data sources and arranging sessions to publicise and explain the final method.REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
22/YH/0155
Date of REC Opinion
22 Aug 2022
REC opinion
Further Information Favourable Opinion