Are research trials safe?
Although there have been rare cases of patient deaths involving clinical trials, experts say the vast majority of clinical trials have impeccable safety records. In clinical trials, statisticians periodically review data on cure rates and side effects.
What kind of research is a trial?
Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.
What does Trial mean in research?
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people.
What is an interventional clinical trial?
Interventional study (clinical trial) A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
What was the purpose of the synapse clinical trial?
SYNAPSE, a trial sponsored by BHR Pharma, was designed to investigate the clinical effectiveness of progesterone, provided in a 6% soybean-oil emulsion as a ready-to-use formulation, under well-controlled conditions.
How is mepolizumab used in the phiii study?
A Randomised, Double-blind, Parallel Group PhIII Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab as an Add on to Maintenance Treatment in Adults With Severe Bilateral Nasal Polyps – SYNAPSE (StudY in NAsal Polyps Patients to Assess the Safety and Efficacy of Mepolizumab)
How many patients are in the ITT trial?
This study is registered with ClinicalTrials.gov, NCT03085797. From May 25, 2017, to Dec 12, 2018, 854 patients were screened for eligibility. 414 patients were randomly assigned with 407 included in the ITT population; 206 received mepolizumab and 201 received placebo.
Why was the protect III clinical trial halted?
The PROTECT III trial, funded by the National Institutes of Health, was conducted in parallel, but the study was halted on the basis of a futility analysis performed after 882 patients had undergone randomization. Here, we report the results of the completed SYNAPSE trial.