Use and validation of BIOMARKERS and proxy-outcomes in pre- and post-registration setting
12 / 2008 - 12 / 2011
Website TI Pharma
Lack of efficacy and clinical safety are still major reasons for drug development projects to be either terminated prematurely or prolonged unnecessarily. The main reason is insufficient predictive capability across the discovery and clinical phases of drug development. This leads to long drug evaluation trajectories, with hard-endpoint studies as the only method of accurate drug evaluation. A solution to these issues could be the use of adequate biomarkers and/or proxy outcome measures across different stages of drug development. Research question : Do biomarkers/proxy-outcomes shorten the duration of drug registration?