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.
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.
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.
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 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.
Seattle Allergy & Asthma Research Institute (SAARI) respects your privacy. We understand that your health information is very sensitive. The law protects the privacy of the health information we create and obtain in providing care and services to you. Your protected information includes your symptoms, test results, diagnoses, treatment plan, and health information from other providers.
SAARI operates http://www.seattleallergy.org. This page informs you of our policies regarding the collection, use and disclosure of Personal Information we receive from users of the Site.
We use your Personal Information only for providing and improving the Site. By using the Site, you agree to the collection and use of information in accordance with this policy.
While using our side, we may ask you to provide us with certain personally identifiable information that can be used to contact or identify you. Personally identifiable information may include, but is not limited to your name, phone number, and email.
Like many site operators, we collect information that your browser sends whenever you visit our site. This Log Data may include information such as your computer’s Internet Protocol (“IP”) address, browser type, browser version, and the pages of our Site that you visit, the time and date of your visit, the time spent on those pages, and other statistics.
For all information relating to patient information will be 21 CFR Part 11 compliant. The prescreen survey health questionnaire also falls under these guidelines. This is the Code of Federal Regulations that establishes the United States Food and Drug Administration regulations on electronic records and electronic signatures. It requires that SAARI implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain.