The PARIS bleeding score is a newly reported score system for assessing out-of-hospital bleeding and thrombosis in patients with DAPT after PCI. Due to possible ethnic variations, we assessed the PARIS bleeding score according to BARC Type 2, 3, or 5 as a clinical end point
in a large-scale, single-center, Chinese population in the real world.
Second primary cancers were considered as a secondary clinical end point
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=0.01).
This is a collaborative effort and needs all development stakeholders to discuss the integrated and interdependent aspects to achieve the expected clinical end point
. This collaborative visualization brings to light the ambiguities, risks and gaps in knowledge that will be encountered during the project.
The Barcelona researchers also are focusing on the negative symptoms of schizophrenia, setting their primary clinical end point
at a 20% or more improvement in negative symptoms.
The earlier this external advice is sought, the more value it will deliver to the development process, by providing intelligence on, for instance, clinical end point
selection, trial design and regulatory strategy.
Critical elements of signatures that correlate most strongly with the clinical end point
of interest must be identified and confirmed.
All elements of the primary end point were adjudicated according to prespecified criteria by an independent clinical end point
Additionally, the search for a biomarker to be used as a surrogate for a clinical end point
in clinical trials is of considerable interest, because it has the potential to shorten the trial, thus reducing both cost and the time to get novel therapies to patients.
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.
After week 4, the dose remains 20 mg (or 10 mg and 50 mg of prednisone and azathioprine, respectively) until the clinical end point
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." Since 1995, the FDA has approved 49 new oncology indications for 37 products as accelerated approvals.