When you hear about a new study, it makes sense that you’d wonder what the findings mean for you. But not all clinical trials are created in the same way, so you and your doctor should get some details before deciding how much impact, if any, the results should have on your own care.
If you have rheumatoid arthritis (RA), your doctor has likely prescribed methotrexate. That’s the gold-standard — the first-line treatment — because this disease-modifying anti-rheumatic drug (DMARD) has been around for a long time and has been repeatedly proven to be safe, effective, and tolerable. It’s also very affordable. (Here’s what you should know about drinking if you take methotrexate.)
As newer RA medications hit the market, some patients (and doctors) are quick to assume that “newer” equals “better,” especially when studies conclude that a new treatment yielded more impressive results than methotrexate alone.
While that may be true in some cases — perhaps for certain groups of patients — a recent analysis of 96 clinical trials revealed that RA studies aren’t usually designed in a way that makes the results easily translatable to regular patients.
While there are many factors that scientists use to determine whether a particular study is solid, this analysis, published in June in Arthritis Care & Research, honed in on whether the design of each study was “pragmatic” or “explanatory.”
Pragmatic trials are carried out in real-world settings using typical patients. That might mean, for instance, asking study participants to take a pill every day at home and to be followed by their regular doctor throughout the trial. Explanatory studies, however, tend to diverge from real-life a bit more: Participants might have to come to a specific laboratory to get the intervention or be monitored by a researcher who’s not their regular health care provider.
While both types of studies can provide valid findings, the results of pragmatic trials are likely to apply to a wider group of people simply because they mimic real-life conditions more closely.
Unfortunately, the Arthritis Care & Research analysis determined that 74 percent of the 96 RA trials they examined were explanatory rather than pragmatic.
Many of these trials required patients to check in with a researcher more often than they would normally see their own doctor or did not allow physicians to alter a patient’s drug regimen during the trial (something that happens frequently in the real world).
Lead study co-author May Choi from the University of Calgary in Alberta, Canada, told MedPage Today that the authors want physicians to understand that many trials are designed in a way that’s pretty different from how patients are normally treated.
That doesn’t mean they’re useless, but doctors and patients should understand that what worked well within the constraints of a clinical study might or might not work the same way in real life. The takeaway: Your mileage may vary.
Make Arthritis Research More Patient-Friendly
If you’re interested in getting involved in research that’s more patient-centric, download and sign up for ArthritisPower®. It’s our patient-centered research registry that lets you record various symptoms, such as pain, fatigue, how well you sleep, and more, and participate in voluntary research as study opportunities come up. Learn more and register here.