Stratified Medicine is about tailoring treatments to specific patients based on their individual characteristics such as demographics, genetics or other biomarker measurements, helping to ensure the highest chance of benefit and minimising the potential for harm or unnecessary treatment.
The Stratified Medicine Working Group collaborates to advise on, develop and implement novel methodology for including biomarkers and other patient characteristics in clinical trials. This includes both the early development and validation of biomarkers together with design and analysis of efficient biomarker-stratified trials.
Our goals are: 1) to initiate collaborative methodology research projects between working group members; 2) to support applications for grant funding for methodology research in stratified medicine; 3) to publish papers promoting suitable methodology for stratified medicine; 4) to support training events for UK-based researchers.
Members of the working group have recently conducted a comprehensive review of the literature on biomarker-stratified trial designs and have secured network funding to develop an online tool for guidance on designing biomarker-stratified trials. The group is also currently planning a workshop to explore trial management and monitoring issues related to biomarker-stratified trials, recognising that implementation of such trial designs in practice is often non-trivial.