Immunology Clinical Trials - Allergy Studies & Research Projects

Clinical Trials, Research & Studies

What is a Study?

A Clinical Trial is the scientific term for a test or study of a drug or a medical device (defined as any treatment not ingested by the body) which is carried out with people as subjects. Clinical trials are conducted to determine:

if the treatment is safe and effective for people to use
how it compares to existing treatments
how to measure its effectiveness if no current treatment exists

Clinical studies are a necessary step toward making new medicines and treatments available for all of us.

Why Volunteer?

When enrolling in a clinical trial you will try a new treatment that may or may not be better than those that already exist but your participation may also lead to eventual improvements to what is available today for others. In addition, you may gain access to new research treatments before they are available to the public but you will also be receiving medical care at a facility you already know and trust at no charge to you or your insurance. And, you may be compensated for your time and travel. Other benefits you MAY receive DEPENDING on the study are:

Free Medications
Free Physicals
Free Bloodwork
Free ECG’s
Free Lung Function Tests
Free Lung Function Tests

But to better understand how the treatments may work on different races and genders, it is important that both males and females of diverse ethnic groups, including African Americans, Hispanics/Latinos, American Indians, Asians, Pacific Islanders, and Caucasians take part in the studies.

What Happens in a Clinical Trial?

Doctors and other health professionals run the necessary tests according to study events and by the strict rules set by the Food and Drug Administration (FDA) to make sure that people who agree to be in the studies are treated as safely as possible. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment or the standard treatment or a placebo (an inactive substance that looks like the drug being tested). By using this “blind” test method, no outside influence can affect the patient’s reaction to the treatment.

Informed Consent

To help you decide if you want to participate in a study, FDA requires that you be given complete and accurate information about the study before you agree to take part. This is known as informed consent. FDA requires that people be told:

This study involves research of an unproven drug or device
What is the purpose of the research
How long the clinical study will take
What will happen in the study and which parts of the study are experimental
Possible physical risks or discomforts
Possible health benefits
Other procedures or treatments that you might want to consider instead of the treatment being studied
Privacy: FDA may look at study records, but the records will be kept secret
Whether any medical treatments are available in case you should be hurt, what those treatments are, where they can be found, and who will pay for the treatment
Person to contact with questions about the study, your rights, or if you get hurt
Your right to end participation in the study at any time.

Formal Consent to Participate

Before you can participate in the study, you must sign the informed consent form, to confirm you have been given this information and it must be written so you can understand it. If you do not understand the consent form you should ask the doctor or other medical person to explain it. It is critical that you understand the consent form in its entirety before you agree to participate in the study.

How Can I Find Out About Clinical Trials?

For general information about clinical trials, call FDA’s Office of Special Health Issues at 301-827-4460 or visit their website.

You can also find more information at the ClinicalTrials.gov website.

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