Clinical research is a branch of healthcare science that determines the effectiveness and safety of medications, medical devices and diagnostic products intended for human use. The research gathered may be used for prevention, diagnosis or treatment of medical diseases. Clinical research in humans is typically conducted in four phases. Each phase of the drug approval process is treated as a separate clinical trial. Once the phase is completed investigators are required to submit their data for approval from the FDA before continuing to the next phase.

When considering volunteering for a clinical trial, it is important to make an informed decision. Below are answers to frequently asked questions that many potential volunteers have about participating in a study. Research participants receive payment for their time, no cost medical care and procedures along with no cost treatment. There is no insurance necessary to participate.

In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available.

Patients considering participating in a clinical trial should talk about it with their physicians and medical caregivers. Potential volunteers should also understand the credentials and experience of the staff and the facility involved in conducting the study.

Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases. However, there are risks involved.

Possible benefits for volunteers:
Play an active role in their health care. Gain access to research treatments before they are widely available. Obtain medical care at health care facilities during the trial.
Help others by contributing to medical research.

There may be unpleasant, serious, or even life-threatening side effects to experimental treatment. The experimental treatment may not be effective. The protocol may require more time and attention than a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.

*Please note: volunteers may withdraw from a study at any time for any reason.

A placebo is an inactive product used to assess the experimental treatment’s effectiveness. The participant, physician, and research staff may not know which volunteer receives a placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, however, the level of medical attention and care that each receives is the same.

After a study phase is complete, the data is collected to determine the drug’s effectiveness, if it is safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study. After phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer-review. Data then may be submitted to the Food and Drug Administration (FDA) for approval.

If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug—in terms of its safety, effectiveness, and cost—to other drugs already on the market or assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.

Patients Rights and Informed Consent Explained

Millions of volunteers participate in government- and industry-sponsored clinical trials each year. Prior to agreeing to participate, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent and it is a process that can help you decide whether or not participating in a trial is right for you.