If interested in participating in a clinical trial, explore our ongoing studies in our Current Studies section..

PHASES OF CLINICAL RESEARCH

Phase I

Trials typically involve healthy volunteers. These trials study the safety of the drug and its interaction with the body.

Phase II

Trials enroll patients with the illness an investigational drug is designed to treat. These trials evaluate whether the drug shows favorable effects in treating an illness and seek to determine the proper dose. The evaluation of safety continues.

Phase III

Trials are the largest part of a clinical-development program are designed to provide the substantial evidence of efficacy and safety required before regulatory agencies will approve the investigational drug as a medicine and allow it to be marketed.

Phase IV

Trials of a medicine that continue even after it has been approved for marketing. They may further evaluate the effect of the medicine for the approved use, assess other potential uses, or yield additional safety data. Regulatory agencies may require these trials to address specific questions.

F.A.Q.

What is a Clinical Trial?

Clinical trials are research studies that evaluate the efficacy, safety, and tolerability of potentially new medical treatments. They are designed to find treatments to improve health and future medical treatments. Clinical trials are conducted under very careful supervision by the pharmaceutical companies and the FDA throughout the studies, and must adhere to strict guidelines that are outlined prior to starting any study. Additionally, approval by an independent Institutional Review Board (IRB), which is dedicated to the protection of study volunteers, is required prior to and throughout the course of every research study.

Who can participate in a clinical study?

Each clinical trial defines who is eligible to take part in the study. Each trial must include only people who fit the patient traits for that study (the eligibility criteria). The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow from participating are called “exclusion criteria”. Trials enroll people who have a specific disease or condition. Others enroll healthy people to test new approaches to prevention, diagnosis, or screening.

Why is a clinical trial performed?

Many clinical trials are conducted to determine the safety and efficacy of a new drug or treatment. However, there are also other reasons why they are performed. Some compare existing, approved treatments (standard treatments) to determine which is more effective. Some help to determine if the treatment is safe to use in an entirely different population, such as in children. Clinical trials are conducted under the supervision of the Food and Drug Administration (FDA) and other regulatory agents. The FDA sets forth rules and guidelines for clinical trials to make sure that the people who are being studied are as safe as they can be.



Clinical trials are conducted under the supervision of the Food and Drug Administration (FDA) and other regulatory agents. The FDA sets forth rules and guidelines for clinical trials to make sure that the people who are being studied are as safe as they can be.

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