Symptomatic Benefit Endpoints
Symptomatic benefit endpoints such as time to pain, time to weight loss and time to performance status loss are common as secondary and sometimes primary endpoints. FDA encourages the use of these as they do represent clinical benefit and are often reasonably quickly maturing.
With the recent dramatic increase in research in targeted therapies has come an increase in use of biomarker endpoints in all phases. These are not generally considered to be clinical benefit endpoints by the regulatory agencies.
With the recent dramatic increase in research in targeted therapies has come an increase in use of biomarker endpoints in all phases. These are not generally considered to be clinical benefit endpoints by the regulatory agencies.