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Clinical endpoints or clinical outcomes are outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then often termed a ...
A priori TDM consists of determining the initial dose regimen to be given to a patient, based on clinical endpoint and on established population pharmacokinetic-pharmacodynamic relationships. These relationships help to identify sub-populations of patients with different dosage requirements, by utilizing demographic data, clinical findings ...
A surrogate endpoint of a clinical trial is a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions or survives. Changes induced by a therapy on a surrogate endpoint are expected to reflect changes in a clinically meaningful endpoint. [8]
The results of the AIM-HIGH trial, published in 2011, showed that adding niacin to statin therapy did not significantly reduce the risk of cardiovascular events compared to statin therapy alone: [1] Primary Endpoint: There was no significant difference in the incidence of major cardiovascular events between the niacin and placebo groups (16.4% ...
The endpoint clinical segment provides solutions to biopharmaceutical and contract research customers in serving complex and late-stage clinical trials.
PFS is widely used as a surrogate endpoint in oncology. [4] The definition of "progression" generally involves imaging techniques (plain radiograms, CT scans, MRI, PET scans, ultrasounds) or other aspects: biochemical progression may be defined on the basis of an increase in a tumor marker (such as CA125 for epithelial ovarian cancer or PSA for prostate cancer).
Positive Recommendation by DSMB to Continue Enrollment of Phase 3 SHIELD II Trial of D-PLEX₁₀₀ to 800 Patients. SHIELD II Enrolled more than 700 Patients to Date; Enrollment Completion Expected in March 2025, with Top-Line Results Anticipated in Second Quarter of 2025
Truveta accelerates therapy adoption with regulatory grade safety and effectiveness data replacing slow and expensive clinical trials and registries. Truveta and its health system members lead the Truveta Genome Project, creating the world’s largest and most diverse database of genotypic and phenotypic information to discover the science of ...