Clinical Trials

Clinical trials are medical research programs that depend on human volunteers who are observed closely to answer questions concerning the identification, treatment and management of illnesses and disease. Clinical studies are the fastest and safest way to find answers and treatments that work in humans to improve health.

Clinical trials are carefully conducted and must follow a strict set of rules and regulations, called a protocol. The protocol is designed to protect the safety of the volunteer to the highest degree. Clinical trials must also be approved by an independent committee, called an Institutional Review Board, or IRB, that examines the risks and benefits of the study and determines if risks are reasonable.

Focus of Clinical Trials

There are different types of clinical trials; they do not always test medicines. Some look at the long-term effects of treatment or the impact of diet, nutrition and exercise on incidence of an illness or disease. Some need volunteers with specific illnesses and some need healthy volunteers. Some examine the effects of a new drug, vaccine or treatment and others examine large populations in natural settings.

Phases of Research

Clinical trials are conducted as part of one of four phases, and each phase has a specific goal.

Phase I

Phase I trials explore how a new medicine or treatment should be given (orally, topically, intravenously) as well as how often and at what dose. Some phase I trials are adding new medicines into known regimens. These trials typically include a small group of patients.

Phase II

Phase II trials may include up to several hundred people further explore the safety and efficacy of a treatment or approach to disease managment.

Phase III

Many Phase III trials have several thousand participants and are focused on comparing a new treatment to a standard treatment. By the time a medicine makes it to a phase III trial, researchers know it is safe and effective. The FDA typically approves a medicine after it successfully completes a phase III trial.

Phase IV

Phase IV trials evaluate the long-term side effects of an FDA-approved treatment.

Patient Participation

Participating in clinical research can make a life-saving difference in the lives of other people with similar conditions. Yet volunteering for a clinical trial isn’t all altruistic; patient participants also benefit in many ways.

Learn more about participation