Question

What is the difference between interventional studies and observational studies? Provide an example of a clinical trial. Explain what makes your example an interventional study or an observational study

Answer 1

Observational study

A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study)

Interventional study

A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.

these are the two most common type of clinical trial.

Clinical trials are a great example of an intervention study. In the case of a randomized controlled trial, participants with the same disease or condition are randomly divided into two groups. One group, called the treatment arm, will be given the intervention, which may be a drug or a device. The other group, called the control arm, will not receive the intervention. The two groups are equally important to the research study, and participants are randomly divided into each group. Both groups are then followed, and their data is compared over time by researchers. With this setup, clinical trials aim to provide a controlled environment to measure the success of a drug, device, or other medical intervention.

The recently launched T1D Exchange Registry Research study is a good example of an observational study. Specifically, it is a longitudinal cohort study, in which information about diabetes management and other important medical history is collected over time from a large number of people with type 1 diabetes.

According to Wendy Wolf, PhD, director of the T1D Exchange Registry, “this project will provide a
significant, publicly accessible way to study longer term issues, such as the effects of aging and the progression of the disease.” By joining and sharing their voices, experiences, and data, the Registry participants add to a comprehensive data set of type 1 diabetes health information in the United States, and drive meaningful treatment, care, and policy.