Session: Design and Analysis of Trials
involving Biomarkers
It is becoming increasingly clear that there is great
heterogeneity in response of specific types of cancer to individual
treatments. The integration of biomarkers that may predict
sensitivity or resistance to individual treatments poses major
methodological issues for the design and implementation of clinical
trials.
Aims
- discuss challenges of designing, implementing and analysing
trials using biomarkers
- review examples of trials in the oncology and cardiovascular
fields that have successfully used biomarkers
Oral Presentations
Click on the links below to view the presentations.
Using biomarkers prospectively in adaptive clinical trials
Designing a preliminary adaptive study to inform a biomarker trial
in Psoriasis
Decision-making in drug development: Choosing a biomarker for Phase
II and predicting the outcome of Phase III
Data modelling methods in clinical trials: Experiences from the
CTMND project
Stratified medicine in practice: Review of predictive biomarkers in
European Medicines Agency (EMA) indications