Joseph Unger, PhD, MS
The National Cancer Institute (NCI)-funded SWOG clinical trials program has added 3.34 million years of life for patients with cancer in the United States because of successful therapies that were validated through its trials. When analyzed, the investment for each year of life gained since the 1950s was $125.
Joseph Unger, PhD, MS, principal investigator, and colleagues analyzed outcomes data from 193 randomized phase III clinical trials tested by SWOG. Dr. Unger is a biostatistician and health services researcher in the Public Health Sciences Division at Fred Hutchinson in Seattle. The findings were published by Unger et al in JAMA Oncology1 and were presented at the 2017 ASCO Annual Meeting (Abstract 6513). 2
Findings and Assumptions
Looking only at the largest and most sophisticated type of SWOG studies completed through 2015, the researchers analyzed 193 randomized phase III clinical trials. Of this group, 23 showed that the new, experimental therapy improved overall survival for trial patients, providing strong enough evidence to change how cancer is treated.
This core of 23 successful clinical trials has produced a steady rise in survival for patients. Dr. Unger indicated that patients with cancer in the United States have gained a cumulative 3.34 million years of life, compared with what their survival would have been without these treatments. By dividing those years of life saved by the estimated cost of all SWOG studies since 1956 (approximately $418 million), Dr. Unger and his colleagues calculated that it took an NCI investment of only $125 for each year of life saved.
Significantly, 84% of those years of life saved have accrued since 1990, a reflection of the accelerating pace of improvement in cancer research. While the focus of the study is on the gains already achieved, the researchers also projected the lifesaving trends forward and calculated that the impact of the same SWOG trials alone would grow to 4.32 million by 2020; to 5.38 million by 2025; and will have nearly doubled to 6.29 million by 2030.
Dr. Unger acknowledged that the study requires numerous assumptions, some conservative, some less so. For example, the study’s central findings are based on the assumption that practice changes were adopted by the oncology community upon publication of the SWOG findings. Calculations also provided in the study show lower improvements in life years gained for patients with cancer if the new therapies were adopted later. If, for example, all treatments took 3 years after publication to be adopted, the years of life saved drops to 2.9 million from 3.34 million.
“The assumptions you make are pretty important,” Dr. Unger said. “I tried to be conservative in our modeling assumptions, so as not to overstate the impact.” For example, because no records of the investment in SWOG trials exist prior to 1985, the researchers used a backward projection of 1980s study costs to the beginning of the SWOG trials, even though the budget for SWOG’s treatment trial program in those early years was almost certainly much less.
“This study just considers the investment dollar cost of conducting these trials,” Dr. Unger said. “Even if my estimate was off by an order of magnitude—and the investment per year of life gained was $1,250—that would still be a very small investment.”
Dr. Unger said the study results provide strong evidence that SWOG and its four sister networks deliver a strong return on the investment required for them to carry out their studies. “If Congress is looking for a cost-effective approach to the design and conduct of studies for new cancer therapies, I can’t think of a better model than the cooperative group system,” he said.
Fred Hutchinson has been the home of SWOG’s Statistics and Data Management Center since 1984. ■
2. Unger JM, LeBlanc M, Blanke CD: The impact of positive SWOG treatment trials on population survival. 2017 ASCO Annual Meeting. Abstract 6513. Presented June 5, 2017.