Editor’s Perspective

Clinical Practice vs. Clinical Trials

June 1, 2020

By Dwight Akerman, OD, MBA, FAAO
Chief Medical Editor, Review of Myopia Management

When I speak with colleagues around the world, the use of the term real-world is widespread. It describes an eye care professional’s accumulated clinical experience in treating patients and is contrasted with academic or FDA randomized controlled trials (RCTs). These trials differ from clinical practice in that they have prespecified inclusion and exclusion criteria, adherence to a prespecified protocol, and typically excellent patient compliance.

Results from RCTs have an advantage over real-world clinical practice when comparing treatment outcomes because they largely control for confounders, bias, and chance. Patient and treatment selection bias, losses to follow-up, variable outcome measurements, and compliance variability can have significant effects on real-world results. Some clinicians have even suggested that RCT regimens may not be relevant to the care of patients because these regimens may be challenging to replicate.

Randomized controlled trials often exclude many patients (Are they the best, or the worst?) and thus may not be generalizable to patients at large. Participants in RCTs are not the all-comers from clinical practice but are often selected for their potential to demonstrate benefit or harm.

When communicating to parents of myopic children, it is critical that you do not inflate the expected reduction in progression of myopia from a particular treatment, i.e., topical atropine, multifocal soft contact lenses, ortho-K, etc. In many cases, real-world clinical experience does not replicate randomized controlled trials, and outcomes can be quite different.

Best professional regards,

Dwight H. Akerman, OD, MBA, FAAO, FBCLA
Chief Medical Editor


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