Technology and the evolution of medical knowledge: What’s happening in the background

Real-world research

As we see each patient and type information into the EHR, we add to an enormous database of medical information. That database is increasingly being used to advance our knowledge of how medicines actually work in the real world with real patients, and has already started providing answers that supplement, clarify, and even change our perspectives. The information will provide observations derived from real populations that have not been selected or influenced by the way in which a study is conducted. This new field of research is called “real-world research.”

An example of the difference between randomized controlled trial results and real-world research was published in Diabetes Care. This article examined the effectiveness of dipeptidyl peptidase 4 (DPP-4) inhibitors vs. glucagonlike peptide–1 receptor agonists (GLP-1 RAs) in the treatment of patients with diabetes. The goal of the study was to assess the difference in change in hemoglobin A_1c between real-world evidence and randomized-trial evidence after initiation of a GLP-1 RA or a DPP-4 inhibitor. In RCTs, GLP-1 RAs decreased HbA_1c by about 1.3% while DPP-4 inhibitors decreased HbA_1c by about 0.68% (i.e., DPP-4 inhibitors were about half as effective). However, when the effects of these two diabetes drugs were examined using clinical databases in the real world, the two classes of medications had almost the same effect, each decreasing HbA_1c by about 0.5%. This difference between RCT and real-world evidence might have been caused by the differential adherence to the two classes of medications, one being an injectable with significant GI side effects, and the other being a pill with few side effects.

The important take-home point is that we are now all contributing to a massive database that can be queried to give quicker, more accurate, more relevant information. Along with personal experience and randomized trials, this third source of clinical information, when used with wisdom, will provide us with the information we need to take ever better care of patients.
 

References

Carls GS et al. Understanding the gap between efficacy in randomized controlled trials and effectiveness in real-world use of GLP-1 RA and DPP-4 therapies in patients with type 2 diabetes. Diabetes Care. 2017;40:1469-78.

Blonde L et al. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018 Nov;35:1763-74.