The other main type of clinical study is an observational study. In an observational study, researchers observe participants on their current treatment plan and track health outcomes.
Clinical studies are a major part of cystic fibrosis research. They take place at Cystic Fibrosis Foundation-accredited care centers all over the United States and enroll people with CF of all ages.
What's the Difference?
Observational and interventional describe the two main types of clinical studies. An interventional study refers specifically to a clinical trial in which researchers are testing a treatment method. The drug development pipeline refers mainly to clinical trials.
The treatment method can range from a potential drug to a vibration vest or even an exercise study. Participants receive one or more treatments (interventions) or a placebo so that researchers can evaluate the effects on the participant's health.
The purpose of an observational study isn't to test potential treatments. These studies are used to develop new ideas about CF and how the disease might best be treated.
Many times, after a drug is approved, the U.S. Food and Drug Administration requires that the pharmaceutical company continue to monitor the effectiveness and safety of the drug through observational studies.
Observational studies often take less time for people who participate in them and may involve questionnaires. Unlike interventional studies, a person with CF can be in more than one observational study at the same time because the studies do not involve changes to a treatment plan.
Under these two types of clinical studies, there are many sub-types. Some of these sub-types are not mutually exclusive. For example, a behavioral study could be observational or interventional.
Behavioral studies are designed to identify and understand how factors, such as self-management, mental health and social support, are associated with health outcomes. Researchers can observe how the behavior of people with CF affects their health in an observational study, or they can conduct an interventional behavioral trial to see if a change in behavior can improve the health of people with CF.
We call people with CF who participate in clinical trials, and all those who support them, trailblazers. Help us blaze a trail to better treatments and a cure for CF.