Surgical Clinical Trials in Gynecology: Rare, Challenging but Desperately Needed

Early Discontinuation, Results Reporting, and Publication of Gynecology Clinical Trials From 2007 to 2020

“…C linical trials represent a critical component of the research ecosystem and frequently guide evidence-based medicine. 1 Although they incur significant professional, financial, and logistical costs-a single drug trial often requiring more than $19 million before approval 2 -their potential effect merits these investments. In gynecology alone, seminal trials changed clinical practice, shifted the direction of the field, and contributed to improved patient outcomes.…”

“…In gynecology alone, seminal trials changed clinical practice, shifted the direction of the field, and contributed to improved patient outcomes. 2,3 However, the benefits of clinical trials can be realized only when trials reach completion and report findings. Inadequate dissemination of trial results squanders limited resources, delays medical progress, and introduces bias into the literature.…”

Controversy: A Fundamental Ingredient of Gynecologic Surgical Progress

“…Initially, there may not be sufficient evidence available to rule out any theories regarding a particular surgical approach or treatment. Given the overall dearth of Phase III trials in gynecologic surgery and the challenges in conducting surgical studies, sifting through available evidence can be challenging and lead to a variety of approaches employed by gynecologists [2,3]. A surgeon's educational background and personal experiences also influence the choice of surgical therapies for patients, as new approaches and tools require additional training and expertise to incorporate successfully into one's procedural armamentarium.…”