a study which aims to generate statistically relevant data about a drug. It can be multicentre, and usually involves thousands of volunteers who are randomly given either control or study therapy.
A human trial, often involving more patients than a phase II trial, to confirm a drug's efficacy, compare it to commonly-used therapies and generate long-term safety data.
Clinical trial conducted to compare the new cancer treatment to the standard (accepted) treatment to discover which treatment is more effective. Phase III trials involve large numbers of patients who are assigned at random to receive the either the new treatment or the standard treatment. In most cases, studies move into phase III only after a treatment seems to work in phases I and II.
a comparative study of treatments which have the potential of providing the best available therapy
a large-scale study to scientifically document the value of the proposed drug, technique, or device
a large-scale trial
a large, usually multicenter placebo controlled trial involving many patients (hundreds to thousands) over a longer period of time
Phase III studies are designed to answer research questions across the disease continuum. Phase III trials usually have hundreds to thousands of participants, in order to find out if there are true differences in the effectiveness of the treatment being tested. Once this phase is completed, the pharmaceutical company will usually submit a New Drug Application to the FDA, provided the results of the trials warrant such a request.
an advanced clinical trial in humans designed to prove whether or not a vaccine is effective. Phase III trials involve thousands of participants and occur only after the experimental vaccine has successfully moved from a Phase I and Phase II trial.
the third stage of human drug testing; these trials are designed to verify and extend the information gathered in Phase II trials, and involve large numbers of participants (several hundred to several thousand). Phase III trials may compare the drug being tested to other therapies or to placebo. Phase IIIa trials are conducted prior to the filing of a new drug application (NDA); Phase IIIb trials are conducted after an NDA is submitted.
A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.
The third and usually final stage in testing a new drug in humans. Used to collect information about the safety of a drug and how well it works. Once this phase is complete, the drug manufacturers may request permission from the Food and Drug Administration to market the drug.
Large controlled trial to gather information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide and adequate basis for physician labeling.
Phase III trials involve the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, efficacy, and appropriate dosage. Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and centers nationwide.
a large-scale, randomized clinical study that compares the results of people receiving a new treatment with results of people receiving a standard treatment
tests a substance in a large number of patients, often in many hospitals. These trials compare the substance with a treatment already in use, or if there is no treatment currently available, with a placebo.
Trial to compare 2 or more treatments for a single type and stage of disease. The end point of a Phase III Trial is usually survival or disease free survival. Phase III trials are most often randomized. Some Phase III trials compare the investigational therapy (the experimental arm) with the current standard of care or best supportive care (the control arm). Other Phase III trials compare 2 existing treatments for the same disease.
Compares two or more kinds of treatment in two or more similar groups of patients, with one group of patients receiving the standard, or control, therapy.
an expanded controlled and uncontrolled trial after preliminary evidence suggesting effectiveness of the drug has been obtained, and intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling.
Phase III trials compare the results of people taking the new treatment with results of people taking standard treatment (for example, which group has better survival rates, and/or fewer side effects). In most cases, studies move into phase III testing only after a treatment shows promise in phases I and II. Phase III trials may include hundreds of people around the country.