Q: What is a clinical research study?
A: Research studies, also known as clinical trials, test the effectiveness and side effects of medicines, medical devices or interventions. Treatment may include a new or investigational medication not yet approved by the Food and Drug Administration (FDA), use of an FDA-approved medication or device in a new way, or a new combination of medications.
Q: Why is clinical research important?
A: The Corvallis Clinic is committed to the study and development of new medical treatments and technological advances. Through Research, our patients gain access to these promising treatments, which may not be currently available otherwise. In addition, research allows The Corvallis Clinic providers to keep up with the latest medical advances.
Q: Can I talk with other family members or friends about whether I should volunteer?
A: The Clinical Research Center at The Corvallis Clinic encourages patients to discuss study participation with family/friends, and usually there is enough time to allow for this. For some studies, however, the eligibility enrollment window is very short; in this instance, you should decline participation if you do not have sufficient time to consult with others.
Q: Who runs the clinical trial?
A: The sponsor pays the cost of a research study. At The Corvallis Clinic, most of our sponsors are drug or device manufacturers. The principle investigator is the physician who is responsible for all aspects of the study at The Corvallis Clinic. The study coordinator is the Clinical Research Center staff at The Corvallis Clinic who coordinates study visits and data management.
Q: Will my insurance be billed?
A: All study visits and study-related procedures/medications may be provided at no cost.
Q: Will I be reimbursed for my time?
A: Most, but not all, studies provide a stipend for study volunteers.
Q: Will study records and procedures, e.g. EKGs, laboratory results, become part of my patient record?
A: Study visit dictation reports, procedures, and lab work from research studies are posted in your patient record and are available to providers as part of your medical record.
Q: What is the time commitment?
A: The number of office visits, procedure visits and the number of study related forms for you to fill out will vary depending on the study. The expectations of volunteers will be thoroughly explained before you are enrolled in the study; this is part of a process known as Informed Consent.
Q: What if I start the study and then decide I don’t want to be in it anymore?
A: You may withdraw from the study at any time.
Q: Can I go on vacation?
A: Study visit schedules usually allow for “windows” around when study visits must take place – it is almost always possible to schedule around patient’s planned travel dates.
Q: How are my rights/privacy protected?
A: An independent group, called the Institutional Review Board (IRB), carefully monitors studies from before the study begins until all patients have completed study care. This group makes sure the study is run in a way that protects volunteers. Your privacy is protected and all of our research staff has training to protect the rights and safety of patients.
Q: How do I find out if I qualify for a study?
A: Research personnel and the study doctor will screen you to determine if you are eligible for a study. Each study has different criteria for study eligibility, but in general, screening will include a review of your medical history, and possibly blood work and an EKG or other imaging procedure.
Q: Do I continue to see my primary care provider for my ongoing health care?
A: You should still see your primary care provider(s) for your ongoing health needs. Clinical trials are typically focused on a particular illness or condition, so they do not provide comprehensive health care.
Q: How can I find out more information about the clinical trial process and other studies taking place in our area?
A: The National Institutes of Health has a website that offers general information about clinical trials as well as a searchable database for current studies. The website is www.clinicaltrials.gov.