generally also requires fewer study subjects to
in clinical trials: Definition and operational criteria.
In MSA and PSP, the absence of surrogate endpoints
makes clinical trials even more difficult, long, and expensive.
Furthermore, surrogate endpoints
are often used to determine treatment efficacy.
In this way, once the steady-state and a pharmacological response, ranging between the 20-80% of maximal effect, corresponding to the linear portion of the sigmoid dose-effect curve, is reached, we can estimate the methadone optimal dose, required to achieve its "clinical surrogate endpoint
", in absence of other confounder factors for U-T/ Cr ratio (e.g.
The Institute of Medicine's Committee on Qualification of Biomarkers and Surrogate Endpoints
in Chronic Disease convened a two-day forum in Washington, DC, in June 2010 to provide stakeholders an opportunity to learn about and discuss a report by the committee that evaluated biomarkers in the chronic disease setting in an attempt to make this previously non-uniform evaluation process more consistent.
However, they will not approve a drug on small effect size of a surrogate endpoint
(PFS), no matter how good its safety profile.
Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using a surrogate endpoint
of overall response rate.
The FDA has indicated that reduction of LDL-cholesterol is an acceptable surrogate endpoint
for accelerated approval of mipomersen for use in patients with homozygous familial hypercholesterolemia (hoFH).
The measurement of cholesterol lowering is called a surrogate endpoint
, which is different from the measurement of the hard endpoints of decreased heart disease or death.
One interesting point raised by this study is the potential value of DFS as a surrogate endpoint
in studies on adjuvant treatment in gastric cancer, which may save time (and lives) for patients (as in colon cancer where DFS is predictive of OS).
The first allows approval to be based on clinical trials that, rather than using standard outcome measures such as survival or disease progression, use "a surrogate endpoint
that is reasonably likely ...