EATRIS is proud to be a partner in the PERMIT project, which has seen two scoping reviews published in the Journal of Personalized Medicine and BMJ Open titled “Methods for Stratification and Validation Cohorts: A Scoping Review” and “Study designs for clinical trials applied to personalised medicine: a scoping review”.
The first paper presents findings of the scoping review that focused on the methods and tools for the design and management of stratification and validation cohorts in personalised medicine. The search was limited to cancer, stroke and Alzheimer’s disease use cases, and showed a lack of information about the quality of data available and the requirements to monitor associated clinical data. In addition, it underlines the scarcity of standards in specific areas such as sample size calculation.
The second paper is a novel review that systematically searched for all trial designs applied to personalised medicine. The findings show that several existing trial designs are applied to personalised medicine, which can be grouped into four core categories. A new classification has been proposed that allows describing trial designs taking into account their corresponding core category and main features. It can be used by readers to explore and better understand the complex field of personalised medicine clinical trials.
These findings lay the foundations for the upcoming recommendations of the PERMIT project to improve the reproducibility and robustness in the design and management of cohorts in personalised medicine studies.