VOLUNTEERS

A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a physician and other research professionals. These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, also known as investigators, to conduct clinical trials to determine the benefits of investigational drugs.

When considering volunteering for a clinical trial, it is important to understand the following information.

Informed consent.

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.

Study drug and placebo.

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. 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.

Qualify for the study.

All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. The factors that allow volunteers to participate in a clinical trial are called "inclusion criteria" and the factors that disallow volunteers from participating are called "exclusion criteria." These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

What to expect.

In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member once they are enrolled in the study. The volunteers' health will continue to be monitored during and after the trial. A detailed description of what's expected of volunteers will be outlined in consent forms along with specific clinical trial information.

Confidentiality of information.

Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the IRB overseeing the research and the sponsor or contract research organization coordinating the trial will also have Access. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies.

Withdraw.

Volunteers may withdraw from a study at any time for any reason.

After the trial.

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.

Benefits and risks.

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.

Possible risks for volunteers:

  - 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.

Don´t forget to ask a physician or medical caregiver…

  - How long will the trial last?

  - Where is the trial being conducted?

  - What treatments will be used and how?

  - What is the main purpose of the trial?

  - How will patient safety be monitored?

  - Are there any risks involved?

  - What are the possible benefits?

  - What are the alternative treatments besides the one being tested in the trial?

  - Who is sponsoring the trial?

  - Do I have to pay for any part of the trial?

  - What happens if I am harmed by the trial?

  - Can I opt to remain on this treatment, even after termination of the trial?

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