Although they offer several benefits when conducted in the right situation, surgical placebo-controlled trials pose ethical and safety challenges in terms of enrolling patients and finding the right professionals to conduct the trial, says Renata Yong, BPharm, a global project manager and senior medical services associate with George Clinical, a contract research organization based in Australia. It’s perhaps no surprise such trials aren’t widely understood as a category, she says.
“There are very few trials comparing surgery to non-operative treatment,” Yong explains. Further, most procedures are not formally evaluated in terms of safety and efficacy. “Ineffective treatment may go unchallenged,” she adds.
Yong will share lessons learned from her research team’s work on a randomized, placebo-controlled clinical trial addressing lumbar spinal canal stenosis, a narrowing of the spinal canal because of degenerative changes of bones or ligaments, at ACRP 2019 this month in Nashville, Tenn. Sponsored primarily by the University of Sydney, the first such trial was conducted at sites in Australia, with a sample size of 160 patients.
Some surgeons are wary of participating in such protocols, Yong says. They grapple with equipoise, or the uncertainty that a treatment will be beneficial. To address that, Yong and team created a working group led by surgeons who had experience in randomized clinical trials, and held seminars to explain the rationale and need for the surgical placebo-controlled trials. She also advises making sure that surgeons have the proper liability and insurance coverage to become involved.
Some 10% of Americans will suffer from lumbar spinal canal stenosis at some point in their lives, Yong says. Recent data estimate that surgery for the condition results in an aggregated hospital bill of $1.65 billion per year in the U.S., though evidence supporting the efficacy of surgery for it is inconclusive. (For more details, see “SUcceSS, SUrgery for Spinal Stenosis: protocol of a randomized, placebo-controlled trial,” coauthored by Yong and 13 other Australia-based researchers in BMJ Open.)
Author: Michael Causey