Clinical trial designed to measure the safety and efficacy.
Phase II studies involve administration of drug to a small number of patients with the primary objectives of demonstrating the effectiveness of the treatment and assessing short term tolerability profile in the target population.
a study evaluating the effectiveness and tolerable dose of a drug in a small group of patients with the same disease.
Effectiveness testing in humans, done if Phase I has been completed and shows acceptable levels of safety. Usually done with 50 to 300 individuals.
A more advanced stage clinical trial that follows the Phase I trials. A phase II trial gathers preliminary information on whether an experimental drug works. Data often are based on laboratory assays that provide quick, but indirect measurements of a drug's effect on disease (see surrogate marker).
Once a drug or device has completed phase I trials, and are proven safe,a phase II trial is conducted to see if a drug or device is effective against a certain disease or condition, like cancer.
The second phase of clinical drug development in which the evaluation of a drug is primarily in patients for safety, tolerability and efficacy. Dosing regimens are tested for magnitude and duration of effect. Positive efficacy is often referred to as clinical â€˜proof of conceptâ€™. This Phase should conclude with an indication of whether the drug works, which patient population to target, and what is the optimal dose (or dose range) at which beneficial effects are maximised and side effects are minimised (â€˜therapeutic windowâ€™)
Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
A Phase II vaccine trial is a controlled clinical study to identify common short-term side effects and risks associated with the test vaccine and to collect expanded information on its immunogenicity. Phase II trials enroll some volunteers with characteristics similar to potential participants of an efficacy (Phase III) trial. They enroll up to several hundred participants and generally have two or more arms.
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
The classification of federally funded trials that test an experimental drug to see how well it works and to study its side effects. Phase II trials often involve several hundred participants who are randomly assigned to take either the drug or a control (the standard treatment for the disease or no treatment at all, known as placebo). These trials are usually double-blinded, which means no one knows who is getting the drug until the trial is over. Length is several months to 2 years.
Testing in patients in order to demonstrate the efficacy of the drug.
A clinical trial in patients with the objective of evaluating the safety and preliminary efficacy of a drug candidate
Testing in cancer patients to determine response rates to treatment.
Phase II trials usually require 100-300 individuals who suffer from the disease or condition that the experimental drug is intended to treat. The objectives of this phase are to confirm safety, determine efficacy in humans over a short period of time and to determine effective dosage levels.
clinical trials to assess short term safety and preliminary efficacy in a limited number of patients with the relevant disease
Phase II trials typically include more patients than Phase I trials and may offer more information about a drug's optimum dose. These trials begin to focus on a drug's efficacy and may be controlled.
The second phase conducted in the drug approval process. Typically a randomized clinical trial with hundreds of patients.
clinical trial that evaluates an experimental drug's safety, assesses side effects, and establishes dosage guidelines.
Part of clinical development in which short term efficacy and potential side effects of an investigational new drug (IND) are tested on a small number of patients suffering from the disease targeted by the drug
Phase II is the second clinical trial in humans, usually in patients rather than healthy volunteers.
study - After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals who are afflicted with the disease or condition for which the drug was developed.