Every day, research uncovers new information about medical conditions and possible therapies. Your involvement in clinical studies could help in the development of new medications. You and many other people may benefit from you willingness to become involved.

Volunteering to participate in a clinical drug study is one of the best ways you can contribute to the understanding of diseases that affect people and the development of new therapies. Volunteers are important to the clinical study phase of the drug approval process. As a volunteer, you are the most critical link in a long chain of research and testing in the development of new medications for a broad range of health problems.

Each year, thousands of people volunteer to participate in clinical drug studies. Benefits to you as a volunteer may include:

• Participating in the research process that may lead to new therapies.
• Receiving medical care from physicians during the study.
• Learning new information about your condition, as well as meeting people with similar conditions.

What is a Clinical Study?
A clinical study is carefully designed to test the effects of a medication, medical treatment, or device on a group of volunteers. Clinical studies are an important step in making new medications available. They measure the drug’s ability to treat a condition, its safety and its possible side effects. Click here to see our list of current studies.

How is a Drug Approved for Testing?
The U.S. Food and Drug Administration (FDA) typically must authorize a drug company’s proposal to conduct clinical studies. Drug companies must do years of laboratory research before they can begin testing medicines in humans.

Who Can Be in a Clinical Study?
People with the condition being studied as well a healthy people can volunteer to participate in a study. The FDA has very strict requirements that specify which studies involve healthy volunteers and which studies involve patients with the condition being studied.

Each study has specific requirements such as age, sex, and medical condition for participants. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate. Known risks and discomforts will be explained by the study physician prior to participating in the study. In addition to the known risks, there may be unknown risks such as medication side effects involved in participating in a clinical study. Study procedures, risks, and benefits are explained to volunteers during the informed consent process.

What is Informed Consent?
nformed consent is the process designed to give volunteers the information that they need to decide about participating in a clinical study. This process allows the volunteer to ask questions and to exchange information freely with the clinical investigator. The clinical investigator is responsible for ensuring that informed consent is obtained from each research volunteer before that person participates in the research study.

Who is the Institutional Review Board?
The IRB is a group of healthcare professionals and members of the local community which must review and approve a clinical study before it begins. The IRB carefully reviews study activities because its primary responsibility is to protect the safety and rights of study participants.

How Can I Become a Study Volunteer?
Health clinics that do research are often looking for study volunteers. For more information on clinical studies and how to become a study volunteer, do either of the following:

• Fill in the "Contact Us" page. Upon receipt, a local healthcare professional will call you or send you additional information.
• Call the phone number on the top of each page to speak with our healthcare professionals who can answer your questions about being in a clinical study.

We welcome the opportunity to speak with you about current and upcoming studies.

Glossary of Clinical Study Terms:

Clinical Investigator or Study Physician: A medical researcher in charge of carrying out a clinical study. Researchers are usually doctors, nurses, pharmacists, or other healthcare professionals.

Clinical Study: A carefully designed study of the effects of medication, medical treatment, or device on a group of volunteers.

Food and Drug Administration (FDA): A government agency that enforces laws on the manufacturing, testing, and use of drugs and medical devices. The FDA must approve a drug for marketing before it can become readily available to the medical community and the public.

Informed Consent: A discussion of procedures, benefits, and risks of a clinical study between clinical investigators and persons interested in participating in the study. The FDA requires that volunteers sign an informed consent form (approved by the IRB) before entering a study.

Institutional Review Board (IRB): A group of healthcare professionals as well as members of the local community. The IRB carefully reviews study activities as it is responsible for protecting the safety and the rights of volunteers.