Should You Participate in Clinical Research?
People participate in clinical research for a variety of reasons.
People who volunteer for clinical trials may gain access to promising
drugs before these compounds are approved by the Food and Drug
Administration for the marketplace. Others choose to participate as a
way to advance science.
What is a Clinical Trial?
A clinical trial or study is a scientific test of the effectiveness
and safety of a therapeutic intervention (such as a drug, surgery,
procedure, device, or vaccine) using consenting human subjects. Clinical
trials can also test new uses of drugs or treatments that are already
approved by the Food and Drug Administration for a specific use.
Clinical trials are carried out under strict guidelines with great
attention to measures of safety.
As a patient, your rights and safety are protected in two important
ways. First, any physician awarded a research grant by a pharmaceutical
company or the Federal Government must obtain approval to conduct the
study from an Institutional Review Board (IRB). The IRB, which is
usually composed of physicians from different specialties as well as
people with no formal science training, is charged with examining the
study's protocol to ensure that the patient's rights are protected, and
that the study does not present an undue or unnecessary risk to the
patient. Second, anyone participating in a clinical trial in the United
States signs an "informed consent" form. This form details the nature of
the study, the risks involved, and what may happen to a patient in the
study. The informed consent tells patients that they have a right to
leave the study at any time.
Patients considering participating in clinical research should talk
about it with their physicians and medical caregivers. They also should
seek to understand the credentials and experience of the individuals and
the facility involved in conducting the study.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being
conducted . The clinical trial team includes doctors and nurses as well
as social workers and other health care professionals. They check the
health of the participant at the beginning of the trial, give specific
instructions for participating in the trial, monitor the participant
carefully during the trial, and stay in touch after the trial is
What are the benefits and risks of participating in a clinical trial?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
There are risks to clinical trials.
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
- The experimental treatment may not be effective for the participant.
- The protocol may require more of their time and attention than would
a non-protocol treatment, including trips to the study site, more
treatments, hospital stays or complex dosage requirements.
Does a participant continue to work with a primary health care provider while in a trial?
Yes. Most clinical trials provide short-term treatments related to a
designated illness or condition, but do not provide extended or complete
primary health care. In addition, by having the health care provider
work with the research team, the participant can ensure that other
medications or treatments will not conflict with the protocol.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial at any time. When
withdrawing from the trial, the participant should let the research team
know about it, and the reasons for leaving the study.
What are the different types of clinical trials?
- Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention trials look for better ways to prevent disease in people
who have never had the disease or to prevent a disease from returning.
These approaches may include medicines, vitamins, vaccines, minerals, or
- Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening trials test the best way to detect certain diseases or health conditions.
- Quality of Life trials (or Supportive Care trials) explore ways to
improve comfort and the quality of life for individuals with a chronic
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply
to clinical trials. In addition, most clinical research is federally
regulated with built in safeguards to protect the participants. The
trial follows a carefully controlled protocol, a study plan which
details what researchers will do in the study. As a clinical trial
progresses, researchers report the results of the trial at scientific
meetings, to medical journals, and to various government agencies.
Individual participants' names will remain secret and will not be
mentioned in these reports.
About Informed Consent
Informed consent is a process by which participants learn the
important facts about a clinical trial to help them decide whether to
This information includes details about what is involved, such as the
purpose of the study, the tests and other procedures used in the study,
and the possible risks and benefits. In addition to talking with the
doctor or nurse, people receive a written consent form explaining the
Questions to ask the Study Coordinator or Physician include:
- 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 happens to me when the study is over?