Frequently Asked Questions

Is A Clinical Trial Right For You?

If you’re considering taking part in a clinical trial, these frequently-asked questions will help you understand your role, and the unique process of clinical trials.

1.  Who can participate in a clinical trial?
2.  What happens during a clinical trial?
3.  What is informed consent?
4.  What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
5.  What should people consider before participating in a trial?
6.  Does a participant continue to work with a primary health care provider while in a trial?
7.  What are side effects and adverse reactions?
8.  What are the benefits and risks of participating in a clinical trial?
9. How is the safety of the participant protected?
10. Can a participant leave a clinical trial after it has begun?

 

1. Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important part of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria". The factors that disallow someone from participating are called "exclusion criteria". These criteria are based on factors like age, gender, the type and stage of a disease, and other medical conditions. Inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

2. What happens during a clinical trial?

The 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 completed.

Some clinical trials involve more tests and doctor visits than someone would normally have for an illness or condition. For all types of trials, the participant works with a research team.

3. What is informed consent

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time. informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

4. What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?

Advance planning is recommended:

1. Write down possible questions to ask.
2. Bring a friend or relative for support and to hear the responses to the questions.
3. Bring a tape recorder to record the discussion to replay later.

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

5. What should people consider before participating in a trial?

Answers to these questions from a trial’s health care team may be helpful in making your decision:

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
• What kinds of tests and experimental treatments are involved?
• How do the possible risks, side effects, and benefits in the study compare with my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the experimental treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of this study?
• How will I know that the experimental treatment is working? Will results of the trials be provided to me?
• Who will be in charge of my care?

6. Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term experimental treatments related to a designated illness or condition, but do not provide extended or complete primary health care.

7. What are side effects and adverse reactions?

Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

8. What are the benefits and risks of participating in a clinical trial?

Clinical trials that are well-designed and well-executed are the best way for eligible participants to:

• Play an active role in their own health care.
• Obtain study-related care at 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 an experimental treatment.
• The experimental treatment may not be effective for the participant.
• The study may require more time and attention than a non-study treatment, including trips to the study site, more drugs, hospital stays or complex dosage requirements.

9. 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.

10. 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.

Source: National Library of Medicine, “Understanding Clinical Trials”. Available at: http://www.clinicaltrials.gov/ct/info/resources;jsessionid=B0C362BDFAD571C76D7907979724E470. Accessed July 12, 2010