Interventional vs. Observational Study DesignSep 8, 2022
Interventional vs. Observational Study Design
|Understanding and selecting the appropriate study design for your clinical study at registration is very important, and has regulatory, funder policy, and journal publication implications.
In short, it comes down to whether the researcher is assigning participants to receive an intervention so that they can study how that intervention relates to a health outcome, or if they are observing health outcomes in patients who already naturally belong to a group of interest (i.e., have a certain condition, are receiving a certain treatment as part of standard of care).
Interventional studies are clinical studies in which participants are prospectively assigned to groups (e.g., experimental and control arms) to receive an intervention(s) or a placebo/no interventions so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
Observational studies are clinical studies in which participants are identified as belonging to groups of interest for study (e.g., patients scheduled to have a tooth extracted, patients that have a pacemaker, patients living in a high-pollution zone). Those identified patients are then assessed for biomedical or health outcomes.
Nearly all interventional studies are required to be registered and many must report results, while most observational studies (except those with funding from the Patient Centered Outcomes Research Institute (PCORI)) are not required to register or report results.
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Tags: clinicaltrials.gov interventional observational registration