FAQS

In the United States, the Food and Drug Administration (FDA) needs to review and approve new medications before they can be used in humans. To receive approval, research studies must be conducted to evaluate safety and effectiveness in human volunteers. Clinical research provides the FDA with this information by testing those medications in a controlled environment and sharing the results.

Seattle Allergy & Asthma Research Institute is a non-profit clinical research center that helps complete these studies, conducting research for companies and other organizations that want to test experimental medications, devices or treatments in the areas of allergy, asthma, and immunological diseases.

The clinical testing of experimental drugs on humans is normally done in four phases. Each successive phase involves a larger number of people. Once the FDA has granted a New Drug Approval (NDA), the medication or treatment becomes able to be prescribed to everyone. After the approval, pharmaceutical companies may conduct additional long term safety studies a.k.a. Phase 4 studies.

For the definition of each of the four phases of clinical testing and for additional information, please visit CenterWatch and ClinicalTrials.gov. Both provide useful resources and information for participants, including ClinicalTrials’ useful glossary of common research terminology.

There are often numerous benefits to participating in a clinical research study, including:

  • Potential to receive a new medication or newly improved medication to treat your condition before it is available to the market
  • High quality medical care by physicians overseeing the studies.
  • Medical visits and lab tests related to the research study are free of charge to qualified participants.
  • Medication/treatment, which might otherwise be costly, is free to qualified participants.
  • Education about the latest research and medical management practices for your condition.
  • Monetary compensation for your time and travel expenses for qualified participants.
  • The opportunity to advance understanding of medical conditions and possible treatments for thousands or even millions of other patients.

  1. Speak with your current physicians and medical caregivers, to determine whether participating conflicts with your current healthcare regimen at all.
  2. Understand the credentials and experience of the individuals and facility conducting the research you’d like to participate in.
  3. Ask the right questions about the trail itself, including:
  • 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?

The point of research is to enlighten the scientific community about the treatment and its effects. With any experimental treatment, there will be some risk from the unknown. However, treatments are carefully researched in a laboratory before trials are conducted involving patients. In a Phase 1 trial, researchers may not be able to tell you much about side effects, because they are still studying it and learning. However, you will be told everything they do know, so you can make an educated decision about participating. You will be asked to report all your side effects to the study staff. You may also 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.

By Phase 3 trials, more is known about the treatment, so there is less risk of harmful side effects. The risks associated with a particular trial will be discussed with you if you choose to enroll.

You will be closely monitored and your treatment will be stopped if we feel there may be risk for you.

We join the medical community in emphasizing safety in our research. 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 our research studies are conducted, we obtain approval from both the FDA and this IRB.

Clinical trials are research; they aim to answer a question regarding an experimental drug, so while everything is not known, we take the appropriate measures to promote safety. Experimental drugs have been thoroughly tested in laboratory trials before they are ever tested with groups of humans. Then, experimental drugs go through Phase 1 and Phase 2 human trials before reaching Phase 3 trials.

Additional safeguards:

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

For more information, please visit: http://www.fda.gov/cder/handbook/develop.htm.

Study length varies depending upon the topic of the study. A study may be as short as a week or as long as several years. Most studies last between 2 months and 6 months. Depending on the study topic, visits to the clinic to participate may be weekly, monthly or another period.

To participate in a study, you may be asked to visit our facility three (3) or more times. We understand that our study participants have busy lives, and we make every reasonable attempt to accommodate your schedule as we meet the study visit criteria together.

Most trials do not allow participants to enroll in more than one trial at a time, particularly if you are receiving treatment. The answer, however, varies on a study-to-study basis. Typically, to participate in a second trial, a gap of many years would be desired between the studies.

Some clinical trials go on for several years after you have stopped receiving treatment. In order to monitor the long-term effects of the treatment you have been given, the researchers will want to keep in touch and know what happens to you.

To follow your experience, you will come back for periodic check ups. The study doctor will send reports of your check ups to the trial center. This is unlikely to make any difference to you, however this data is important to complete the study’s findings in many cases.

Please know that, in some cases, it may be several years before the results of your trial are made public!

At the Seattle Asthma & Allergy Research Institute, subject privacy is of utmost concern. Our study database is in full compliance with 21 CFR Part 11 to ensure proper encryption and data integrity. Although the Institute is a not a healthcare entity and HIPAA does not apply, we take privacy quite seriously, regardless of any legal obligation or lack thereof.

If you live in Washington or the surrounding states and are interested in participating in one of our research studies, we hope you will contact us!

Online pre-screen survey (to apply): Pre Screen Survey

email: Studies@asthmainc.org (please tell us the best time and way for us to reach you)

Phone: (206) 525-5520

If you are a patient at Northwest Asthma and Allergy Center, while your information is kept confidential, you may be contacted by general letter or postcard if you meet study entry criteria. If you are interested, please contact us as described above.

Absolutely! As a non-profit research center, donations are vital to our work. You are welcome to donate online or by check. Please see more on our Donation

Yes! We are often starting new trials, and welcome your help spreading the word to study volunteers. Please send them to our website to sign up, or give them the link to our pre-screen survey.

We welcome the opportunity to meet new study sponsors in the areas of allergy, asthma, and immunological diseases. Please contact to discuss your needs and how we can help.