What is clinical research?
How are experimental drugs tested in humans?
Why participate in a Clinical Research Study?
Benefits of participation
How do I know it's safe?
Risks and drawbacks
Side effects
After the trial
How can I volunteer to participate in a research study?

What is clinical research?
In the United States, the Food and Drug Administration (FDA) must approve all new medications before they can be used in humans. New medications must complete extensive testing in clinical research before they are approved by the FDA and marketed in the United States. For medications to receive FDA approval, research studies must be conducted to evaluate safety and effectiveness in human volunteers.

An Independent Review Board (IRB), a group of medical professionals and members of the community, review all clinical research studies before they can begin. The primary goal of the IRB is to advocate for patient safety. Before a research study can be conducted, approval by both the FDA and the IRB must be obtained.

ASTHMA, Inc. (Associated Scientists to Help Minimize Allergies) is a non-profit clinical research center focused on studies involving individuals with asthma, allergies, eczema and sinusitis. We conduct research studies for companies that want to test experimental medications, devices or treatments.

How are experimental drugs tested in humans?
The clinical testing of experimental drugs is normally done in four phases, each successive phase involving a larger number of people. Once the FDA has granted a New Drug Approval (NDA), pharmaceutical companies also conduct post marketing or late phase 3/phase 4 studies.

For more information, go to: http://www.centerwatch.com/patient/backgrnd.html.

Why participate in a Clinical Research Study?
People participate in clinical research for a variety of reasons. People who volunteer for phase 2 and phase 3 trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the physicians during the course of the study. This care also may be free.

People 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.

Other questions to ask 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?

Benefits of participation include:

• All medical care/visits related to the research study are free of charge to qualified participants.
• All laboratory tests and study medications are free of charge to qualified participants.
• Potential to receive a new medication or newly improved medication to treat your condition.
• Education about the latest medical management and research treatments for your condition.
• Monetary compensation for your time and travel expenses for qualified participants.

How do I know it's safe?
Experimental drugs have been thoroughly tested in laboratory trials before they are ever tested with groups of humans. Then, experimental drugs must get through human trials at phase 1 and 2 before they can be used in phase 3 trials. Clinical trials are research; they aim to answer a question regarding an experimental drug.

There are many other safeguards for people taking part in trials:

• The trial plan (protocol) is inspected and must be approved by an ethics committee.
• The running of the trial is supervised by a data monitoring committee during the trial.
• Your privacy is protected.
• You must be told all about the benefits and risks before you agree to take part.

For more information, go to: http://www.fda.gov/cder/handbook/develop.htm.

Risks and drawbacks
With an experimental treatment, there will be some risk. Not a great deal will be known about the treatment. You will be closely monitored and treatment will be stopped if it is thought there is any risk for you.

Remember - even in phase 1 or 2 trials, the treatment has been carefully researched in the laboratory before it is given to patients.

With phase 3 trials, more is known about the new treatment so there is less risk that there could be a harmful side effect.

Side effects
There is a chance you will get side effects you (and your doctor) were not expecting. If you are in a phase 1 trial, the researchers may not be able to tell you much about side effects. You will be told everything they do know before you agree to take part in the trial. You will be asked to report all your side effects to the study staff. You may be asked to keep a diary at home or fill in questionnaires about feeling sick or tired. You can withdraw from a trial at any point.

After the trial
Some trials go on for several years after you have stopped having treatment. The researchers need to know what happens to you so that they can monitor the long term effects of the treatment they have given you.

Your study doctor will send reports of your check ups to the trial center. This is unlikely to make any difference to you. But you should understand that it may be several years before the results of your trial are made public.

How can I volunteer to participate in a research study?
If you live in Western Washington, and are interested in participating in one of our research studies, please email us at studies@asthmainc.org and tell us the best method and time for us to contact you or call us at: 206-525-5520 or 888-400-7765.

Most of our studies require 3 or more visits to our facility. We make every reasonable attempt to accommodate your schedule based on study visit criteria. Click here to see our Health Questionnaire for Potential Research Volunteers and our generic Pre-Screening Consent Form.

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From: CenterWatch Clinical Trial Services