Define phase 3 clinical trials

Be sure to ask the researchers what their study requires. Phases of clinical trials: when clinical research is used to evaluate medications and devices 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. Phase I trials Researchers test an experimental drug or treatment in a small group of people for the first time. Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects.

These studies also help to decide on the best way to give the new treatment. Phase I trials carry the most potential risk. But phase I studies do help some patients. For those with life-threatening illnesses, weighing the potential risks and benefits carefully is key. Sometimes people choose to join phase I trials when all other treatment options have already been tried. If a new treatment is found to be safe in phase I clinical trials, a phase II clinical trial is done to see if it works in certain types of cancer.

The benefit the doctors look for depends on the goal of the treatment. It may mean the cancer shrinks or disappears. In some studies, the benefit may be an improved quality of life.

Many clinical trials look to see if people getting the new treatment live longer than most people do without the treatment. Larger numbers of patients get the treatment in phase II trials, so less common side effects may be seen. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment. Because doctors do not yet know which treatment is better, study participants are often picked at random called randomized to get either the standard treatment or the new treatment.

When possible, neither the doctor nor the patient knows which of the treatments the patient is getting.

Phase 3b Clinical Trial means a human clinical trial of a product that is initiated after the NDA is filed , but before such product obtains Regulatory Approval , the goal of which trial is to provide additional data for marketing support and the launch of such product in the Territory. Phase 3 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.

Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C. Phase 4 Clinical Trial means a product support clinical trial of a Product that is commenced after receipt of MAA Approval in the country where such trial is conducted.

Phase 4 Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies and post-marketing surveillance trials. Phase 1 Clinical Trial means a human clinical trial of a product in any country, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, that would satisfy the requirements of 21 C.

Phase IIb Clinical Trial means a relatively longer and larger Phase II Clinical Study designed to study the effectiveness of different doses of a particular Product against placebo or other positive controls for a particular Indication in patients with the disease or condition under study, which is determined by the PDC to be a Phase IIB Clinical Study.

Phase II Clinical Trial means a human clinical trial in any country that is intended to initially evaluate the effectiveness of a Product for a particular indication or indications in patients with the disease or indication under study or would otherwise satisfy requirements of 21 CFR Phase I trials are concerned primarily with establishing a new drug's safety and dose range in about healthy volunteers.

How a drug is absorbed, distributed, metabolized and excreted by the human body is called Pharmacokinetics. This is determined through frequent blood draws usually in an inpatient environment to check for the level of drug in the blood plasma.

Pharmacokinetic trials are usually considered Phase I trials regardless of when they are conducted during a drug's development. Dosage range of a new drug is determined by administering increasingly larger doses to one or more groups of subjects, who are closely monitored for harmful side effects. The goal is to learn the maximum tolerated dose that does not produce unacceptable side effects.

Phase I studies may involve risks even though an investigational drug has passed the Preclinical phase of testing.