NCI TrIals Have Helped Cancer Patients to Live Longer
Therapies administered in publicly funded clinical trials generated more than 14 million additional life-years for patients with cancer between 1980 and 2020, according to a new analysis.
The trials were conducted by the National Cancer Institute’s (NCI’s) National Cancer Clinical Trials Network (NCTN).
The findings underscore the critical role of government-sponsored research, according to first author Joseph M. Unger, PhD, of Fred Hutchinson Cancer Center, Seattle, and colleagues.
The findings were published online December 8 in the Journal of Clinical Oncology.
For the study, the team assessed phase 3 trials that had statistically significant findings for at least one clinical, time-dependent outcome. The majority of the trials were related to breast, gynecologic, and lung cancers.
The 162 trials included in the analysis involved 108,334 patients and represented nearly a third of NCTN trials, the authors note. Most studies (90.1%) were published in high-impact scientific journals, and they were cited in the literature 165,336 times at a mean of 62.2 citations per trial per year.
Nearly 90% (87.7%) of these trials were cited in cancer care guidelines that recommended the treatments studied.
“Overall, 82.1% (133/161) of trials showed overall survival favoring the experimental arm to some extent, including 92 instances (56.8%) where overall survival for the experimental arm was statistically significantly superior,” the authors note.
They mapped the benefit onto the US cancer population using national cancer registry and life table data.
They estimate that the clinical trials generated 14.2 million additional life-years for patients with cancer up to 2020.
“The 14.2 million life-years these trials added through 2020 represents 4.2 percent of the 336.8 million years of life lost in the U.S. due to cancer from 1980 – 2020,” notes a press release from the SWOG Cancer Research Network, which is part of the NCTN.
“The researchers further project that by 2030, this same set of already completed studies will have added 24.1 million life-years for patients,” it adds.
The team also evaluated the funding of these clinical trials. The total federal investment to conduct these trials, as calculated using public data on estimated funding for the trial groups, was $4.63 billion.
“The federal investment cost per life-year gained through 2020 was $326 in US dollars,” the authors estimate.
Unger, a SWOG health services researcher and biostatistician, said the work “provides a clear statement about the impact of publicly funded cancer research.
“When we discuss investments in infrastructure, it’s important to also consider scientific infrastructure. In the US, the NCI-sponsored network groups have been a vital element of the scientific infrastructure of clinical research for decades and have returned incredible value to cancer patients and to the US taxpayer,” he added.
Unger and co-authors acknowledge that the $326 per life-year gained, which represents the federal government’s investment, does not encompass the costs of initial drug discovery, early testing, and the costs of conducting the trials, but they also note that multiple additional patient benefits derived from NCTN trials are not accounted for in the statistics.
“These trials have also made substantial contributions in ways that are harder to measure,” Unger stated. “For instance, negative trials are critical for showing what treatments should not be used, and federally sponsored research groups also provide critical opportunities to mentor new generations of clinical researchers.
“And for patients, these trials routinely provide access to treatments for underserved patient populations that may not be as accessible in industry-sponsored trials.”
NCI Director Monica M. Bertagnolli, MD, who was not involved in this study, commended the “generosity and courage of patients who participate in clinical trials. This work is a clear demonstration that those who do so make a tremendous contribution to society.
“We also acknowledge the work of clinical providers and other caregivers who go above and beyond usual care to make clinical trials possible,” she said in a statement. “This result validates the key role of NCTN and other networks in improving the outlook for patients with cancer and progressing toward our goal to reduce the cancer death rate by half within 25 years.”
The research was funded by grants from the National Institutes of Health/National Cancer Institute. Unger has disclosed no relevant financial relationships.
J Clin Oncol. Published online December 8, 2022. Full text
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at [email protected] or on Twitter: @SW_MedReporter.
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