Recent clinical development programs have made significant progress by incorporating biomarkers in early phase trials. These biomarkers offer valuable insights into target engagement, monitor pharmacodynamic responses, and inform dose-exposure-response relationships, enhancing study design. However, careful biomarker selection is crucial, as they can accelerate drug development, particularly in diseases where traditional clinical endpoints are hard to measure due to sample size or exposure duration limitations.
Read this white paper to learn more about:
- Novel biomarker technologies
- Analysis considerations
- The impact of regulatory bodies on protocol decisions
- Operational aspects of using biomarkers or biomarker signatures as endpoints in Phase I and II studies
Authors:
Michael Murphy, MD, PhD
Chief Medical and Scientific Officer
Lissenya Argueta, PhD
Fellow, Clinical Research Methodology
