Trends in Published Clinical Trial Phases Among Surgical Specialties, 2007-2017.

Abstract

S urgical practices are more dynamic than in the past and are advancing at the speed of evidence and translation. Given that randomized controlled trials (RCTs) are the criterion standard source of evidence, it will probably come as no surprise to practicing surgeons that the annual rate of RCT public reporting is on the rise. In this issue, Niforatos et al elegantly confirm that not only has the rate of RCT reporting steadily increased over the last decade, but there has been a trend toward more reporting of phase IV studies. The findings of Niforatos et al are important as they conclusively support that clinical investigators are making remarkable progress towards developing, testing and validating new approaches to surgical care across specialties. Their results indirectly suggest that surgical innovation is alive and well and that surgeons are overcoming barriers to conducting surgical trials. This deserves remark as there was a time when RCTs were thought to be beyond the reach of surgeons, with little expectation that surgery would advance with the benefit of scientific rigor. Indeed, as the superiority of RCTs and the quality of clinical research was brought into focus at the turn of the century, barriers to surgical randomization were much discussed and detailed. Blinding, technical learning curves, doctor and patient equipoise, funding constraints, quality assurance, and quality control were called out as obvious challenges to the conduct of RCTs in surgery. Fortunately, the solution to achieving high fidelity technical quality, video-recording, was embedded in the technology of laparoscopic surgery, ending the need for costly, in person proctoring. Video-recording surgery immediately raised the quality of surgical RCTs by facilitating the standardization of technical requirements, surgeon credentialling and trial auditing. The quality of individual trials may still be called into question,