A full scale clinical trial to determine drug efficacy and safety prior to seeking marketing approval
a clinical study that examines the new drug's efficacy and safety in a large number of patients suffering from the disease (1000 to 5000 patients). Physicians administer the new drug to patients that meet a set of criteria. These patients are closely monitored to confirm efficacy and safety and to identify adverse events.
a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of phase III clinical trials it will receive formal approval from the FDA
a large scale often enrolling hundreds to thousands of patients, testing usually against what are standard medical devices or drugs
an extensive clinical trial in a large number of patients
a study that is being done in a specific population of cancer patients where a standard treatment is compared to a newer treatment that has shown promise in that area, i
Large controlled study to determine the ability of a vaccine to produce a desired clinical effect on the risk of a given infection, disease, or other clinical condition at an optimally selected dose and schedule. These trials also gather additional information about safety needed to evaluate the overall benefit-risk relationship of the vaccine. Phase III trials usually include several hundred to several thousand subjects.
a test in a large group of patients with the targeted condition to further test the efficacy and toxicity of a drug
Definitive studies in patients to determine efficacy and safety of a drug prior to marketing approval
An advanced-stage clinical trial that should conclusively show how well a therapy works in comparison to other treatments. Phase III trials can be longer and are usually larger than Phase II trials, and frequently involve multiple test sites. Their goal is the statistical measurement of how well a therapy extends the survival of patients or otherwise clinically improves the health of patients under treatment.
These are pilot efficacy studies aimed at generating statistically relevant data.
These studies are the definitive trails conducted to demonstrate the safety and effectiveness of a new drug for the diagnosis or treatment of a disease.
A phase 3 study compares a new treatment with the best treatment currently available and the following are monitored:â€¢ the effect of the treatment on the cancer â€¢ how long the effect lasts â€¢ the side effects of the treatment â€¢ any possible longer term problems which could develop.