a clinical study that examines the new drug's safety and efficacy at various doses and involves approximately 100 to 500 volunteer patients suffering from the disease.
a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
Controlled clinical study of a vaccine to identify common short-term side effects and risks associated with the vaccine, to collect additional information on its immunogenicity, and to collect initial information on efficacy. Phase II trials enroll some subjects who have the same characteristics as persons who would be enrolled in an efficacy (Phase III) trial of a vaccine. Phase II trials enroll up to several hundred participants.
a test in patients with the targeted condition to test the efficacy and toxicity of a drug
The assessment in patients of a drug to determine close range and preliminary efficacy
A more advanced stage of a clinical trial, following a Phase I trial. A Phase II trial gathers preliminary information on the efficacy of the therapy. In Phase II trials patients are randomly assigned to receive the therapy or they are randomly assigned to a control group which gets the standard treatment or no treatment at all.
the second clinical trial of an experimental drug, designed to evaluate the drug's effectiveness in humans. Drugs that fail phase one never make it to phase two. This second clinical trial usually involves 300 or fewer volunteers. Phase II clinical trials are part of the U.S. FDA approval process.
A scientifically controlled study carried out in, usually to test the effectiveness of a new treatment.
Refer to explanation/diagram [link to Regulatory & Trials Process] in Clinical Development section
Small-scale drug studies in patients that are designed to characterize a drug's effects on a particular disease. These studies usually evaluate more than one drug dose and generally compare the new drug to therapy that is already known to be effective.
Testing of new drugs to find: • the dose of treatment • the frequency of treatment and possibly the particular cancers which may respond best to the treatment.
