As the volume of successful clinical trials has increased, so has the use of the phrase “real world setting.” What’s this all about? Why isn’t this phrase typically found in JAMA Ophthalmology articles?
As background, some recent clinical trials have provided remarkable advances in ophthalmology. For example, a recent clinical trial evaluating intravitreous antivascular endothelial growth factor biologics for diabetic macular edema (DME) found that approximately 75% of study participants gained 2 or more lines of vision, fewer than 5% lost 2 or more lines, and more than 90% were 20/40 or better at 2 years among eyes that started 20/50 or worse. These outcomes far surpass outcomes of similarly treated eyes with laser.
Such results followed a median of 6 injections in the first 6 months, 3 injections in the second 6 months, and 5 injections in the second year after initiating treatment, coupled with 13 scheduled visits in the first year and a median of 10 visits in the second year. At least in DME, although not necessarily in cases of choroidal neovascular age-related macular degeneration, the median injection number approaches 0 by 5 years after initiating therapy.
Subsequent to publication of these results, numerous articles have appeared that claim inferior outcomes for patients who were not in these trials. These conflicting findings were presumed to be due, in part, to difficulties associated with adherence to frequent injections and even more frequent visits in the first 2 years of therapy.
However, such seemingly inferior results sometimes are excused as “real world” findings, in contrast to the clinical trial setting. Why doesn’t the phrase “real world,” then, typically appear in JAMA Ophthalmology?
It’s not because such comparison studies do not have merit. It’s simply out of respect to the people who participate in clinical trials—they are every bit “real” people who exist in a “real” world where they received “real” treatment in a clinical trial setting. These are people who volunteer and take risk to help themselves or others advance the field of medicine. Thus, as editors review submissions, they prefer not to label people who participate in clinical trials as people who are in some imaginary, abstract place.
The solution? Consider patients who participate in a clinical trial as receiving care in a real world clinical trial setting—in contrast to other patients who receive care in a real world clinical practice setting. It’s real to all of them.
Now, those challenges of getting outcomes in the clinical practice setting to match or exceed those in the clinical trial setting? That’s for another day.