clinical trials and biomarkers in cmt

Biomarkers in Clinical Trials

In contemporary cardiovascular practice, the most common and useful applications of biomarkers focus on disease diagnosis, with troponins for myocardial infarction and natriuretic peptides for heart failure representing the most notable examples. Identification of additional cardiovascular diagnostic markers has proved challenging, however, because high quality studies for diagnostic indication...

Editorial Biomarkers in Clinical Trials

In contemporary cardiovascular practice, the most common and useful applications of biomarkers focus on disease diagnosis, with troponins for myocardial infarction and natriuretic peptides for heart failure representing the most notable examples. Identification of additional cardiovascular diagnostic markers has proved challenging, however, because high quality studies for diagnostic indication...

Biomarkers and surrogate endpoints in clinical trials.

One of the most important considerations in designing clinical trials is the choice of outcome measures. These outcome measures could be clinically meaningful endpoints that are direct measures of how patients feel, function, and survive. Alternatively, indirect measures, such as biomarkers that include physical signs of disease, laboratory measures, and radiological tests, often are considered...

Biomarkers of Toxicity Panel in Clinical Trials

T he notion of “biomarker” is not new. FDA defines a biomarker as the measurable endpoint that can be used as an indicator of a particular disease or some other physiological state of an organism. There are numerous publications in the literature addressing the importance of biomarkers in clinical trials, and especially in drug development. In a clinical laboratory, testing for biomarkers can v...

Biomarkers in osteoarthritis: a clinical trials perspective

Using biomarkers prospectively in adaptive clinical trials

A standard approach to biomarker research is to retrospectively examine interactions between biomarkers and treatment effects. An alternative approach of examining such interactions prospectively has advantages. First, if the biomarker information is required for randomization then eliminates missing biomarker information. Another is that nonresponding biomarker subtypes in a multiarmed trial t...