At 1 year, intracoronary infusion of BMC was associated with a reduction in the prespecified combined clinical end point
of death, recurrence of myocardial infarction, and any revascularization procedure (P=0.
The clinical end point
trial - REDUCE-IT (Reduction of Cardiovascular Events With EPA--Intervention Trial)--that Amarin plans for AMR101 will enroll about 8,000 patients with elevated triglycerides and will last for 6 years.
Critical elements of signatures that correlate most strongly with the clinical end point
of interest must be identified and confirmed.
These approvals can be based on a surrogate end point that is considered "reasonably likely" to predict clinical benefit, or on an effect on a clinical end point
"other than survival or irreversible morbidity.
survival; treatment must have a significant effect on the proposed biomarker; the biomarker must have a significant impact on the clinical end point
; and the full effect of treatment on the clinical end point
must be captured by the biomarker.
The clinical end point
combines safety and efficacy parameters.
In 2007, a paper was published in the peer reviewed journal, Dermatologic Surgery entitled "Results of a Survey of 5,700 Patient Monopolar Radiofrequency Facial Skin Tightening Treatments: Assessment of a Low-Energy Multiple-Pass Technique Leading to a Clinical End Point
The report, which provides analysis of 12 high-interest diseases, finds that in major depression, physicians rated a patient's quality of life to be a highly important clinical end point
while payers gave quality of life a low importance rating.
The Food and Drug Administration has changed the clinical end point
of a large study designed to assess the effectiveness of a patent foramen ovale closure device in patients with migraines.
Clinical end point
tradeoffs that are most influential to physicians.
But her main focus was on the drug's impact on quality of life, increasingly seen as a major clinical end point
in the management of chronic incurable diseases such as Crohn's disease, heart failure, and arthritis.
At first you'll see results of studies with carotid IMT or intravascular ultrasound because we still don't understand the mechanisms of action or dosing of some of these drugs well enough to do the large, classic, clinical end point
trials," he said.