The PARIS bleeding score is a newly reported score system for assessing out-of-hospital bleeding and thrombosis in patients with DAPT after PCI.[3] 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 committee (15).
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 is reached.
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.
