Molecular biomarkers in clinical development: what could we learn from the clinical trial registry?

Aim: Objective of this research is to assess whether the trend of stratified medicine widely discussed in scientific literature is translated into real clinical trials registered in ClinicalTrials.gov .

Methods: By semi-automatic screening of over 150,000 trials, we filtered trials with stratified biomarker to analyze their therapeutic focus, major drivers and elucidated the impact of stratified biomarker programs on trial duration and completion.

Results: >5% of trials are using molecular biomarker for stratification; duration of such trials is longer. 21% of them are done in late stages and Oncology is the major focus.

Conclusion: Trials with stratified biomarker in drug development has quadrupled in last decade but represents a small part of all interventional trials reflecting multiple co-developmental challenges of therapeutic compounds and companion diagnostics.