Volunteering for a Clinical Trial
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.
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What is a clinical trial?
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
Clinical trials are usually conducted in three phases (I, II, III).
Only a small number of people participate in phase I trials while the later
phases involve a larger number of volunteers.
Who can participate in a clinical trial?
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
Some research studies seek participants with specific
illnesses or conditions to be studied in a clinical trial, while others require
healthy participants. It is important to note that inclusion and exclusion
criteria are used to identify appropriate participants, promote participants'
safety, and ensure that researchers learn the information they need.
How does a clinical trial work?
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
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.
What questions should be asked before
choosing to participate?
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.
Questions 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?
What can volunteers expect if they choose to participate?
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.
What is informed consent?
For information about the informed consent process when participating in clinical trials, please click here.
What are the benefits and risks of joining a trial?
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.
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.
Please note: volunteers may withdraw from a study at any time for any
Does information remain confidential and
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 tSectionKey="Volunteering"o personal
information. This is explained more specifically in the consent form that
participating volunteers are asked to sign. As a clinical trial progresses,
researchers report the results of the trial at scientific meetings, to medical
journals, and to various government agencies.
What happens 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.
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.