Nearly half of SOG Cancer Research’s phase 3 clinical trials, funded largely by the public, yielded evidence at a modest cost compared with pharmaceutical company-funded trials, and even studies with negative findings nevertheless influenced clinical practice, according to the study.
The Inspiration Behind the Study
Lead author Joseph M. Unger, PhD, a health services researcher and biostatistician for SWOG at Fred Hutchinson Cancer Research Center, told HemOnc Today that he was inspired by the U.S. Patent and Trademark Office’s Cancer Moonshot Challenge to evaluate cancer studies from a research process perspective.
Founded in 1965 and known for decades as the Southwest Oncology Group, SWOG has amassed a huge data set that includes detailed information on over 1,400 cancer clinical trials. The group’s 60th anniversary, celebrated 3 years ago, prompted Unger and colleagues to look at this data set to quantify the impact of these trials.
“I have worked in the setting of NCI-sponsored clinical trials as a trialist and statistician, and the fact that SWOG as a group had just turned 60 made me realize that SWOG, or more broadly, the NCI-sponsored network groups, are a research process,” he said. “This research process has not been examined from a 30,000-foot perspective in terms of its value to [patients with] cancer.
Unger and colleagues reviewed data from 182 phase 3 trials conducted by SWOG or led by other NCTN groups in collaboration with SWOG between 1980 and 2017 that included 148,028 participants.
“We examined each of the trials in terms of whether they had been cited in the guidelines. That enabled us to examine the clinical impact as measured by informing guideline care,” Unger said. “We also evaluated whether trials were part of an FDA indication package label.” Researchers found 82 (45%) of the trials to be “practice influential,” meaning they influenced National Comprehensive Cancer Network clinical guidelines (n = 70), new FDA drug approvals (n = 6) or both (n = 6).