Cancer lethality: an important burden metric to consider for the allocation of clinical trial research funding from all sources

Abstract

<h3>Objectives:</h3> To identify trends and discrepancies between the number of clinical trials funded by public, industry, and other (individuals, universities, and community-based) organizations and measures of individual- and population-level cancer burden. <h3>Methods:</h3> Clinicaltrials.gov was queried for US trials initiated from 2007-2017 in 18 cancer types. For each cancer, incidence and mortality rates were obtained from the CDC, and person years of life lost (YLL) was obtained from the SEER database. Trials were categorized by funding sources and analyzed by measures of cancer burden: incidence (I), mortality (M), YLL, and lethality (L, years of life lost per new diagnosis). Standardized ratios of the number of new studies each year to cancer burden metrics were generated. These ratios were labeled as studies funded by public sources (#P/I, #P/M, #P/YLL, #P/L), industry sources (#I/I, #I/M, #I/YLL, #I/L), and other sources (#O/I, #O/M, #O/YLL, #O/L). Mean annual ratios for GYN cancers were compared to other cancers using Wilcoxon rank-sum tests. Rates of change (ROC) for these ratios over the 11-year period for each funding source were analyzed by linear regression. <h3>Results:</h3> Breast cancer was the most studied cancer among public, industry, and other funded sources, averaging 71.3, 101.6, and 101.0 new studies per year. For new studies in GYN cancers, ovary ranks 7th, 7th, and 10th; cervix 13th, 16th, and 13th; uterus 12th, 14th, and 12th. While breast and prostate cancers rank 11th and 17th in Lethality, the mean ratios for breast (#P/L 22.12, #I/L 31.84, #O/L 31.68, Figure 1) and prostate (#P/L 22.61, #I/L 33.37, #O/L 27.21) are the two highest across all 3 funding sources. Ovarian cancer ranks 4th in Lethality with 11.14 years of life lost per new diagnosis, yet it ranks 12th in mean #P/L (2.086 - lower than 10 others at p<0.05), 10th in #I/L (2.886 - lower than 9 others at p<0.05), and 14th in #O/L (1.557 - lower than 13 others at p<0.05). Cervical cancer is the 7th most lethal, but its ratios rank 16th in all funding categories (#P/L 1.373, #I/L 0.886, #O/L 1.108). Uterine cancer is the 12th most lethal with ratios ranking 8th (#P/L 5.755) 11th (#I/L 3.387), and 12th (#O/L 4.246). Over the 11-year period, the mean #P/L ratios for 4 of 18 cancers (uterus, testicular, brain, esophagus) had a significant negative slope or rate of change (p<0.05). Bladder cancer had the only positive ROC. For #I/L over 11 years, 9 of 18 cancers, including ovarian, had a significant positive ROC. None had a negative ROC. In other funded studies, 7 cancers had a significant positive ROC, and 11 were stagnant. For GYN cancers across all four cancer burden parameters, uterine showed a significant negative slope in the number of public funded studies and ovarian cancer had a significant positive slope for industry funded studies. <h3>Conclusions:</h3> GYN cancers have significantly fewer initiated studies when compared by Lethality across funding categories. Lethality incorporates incidence, mortality, and YLL. It is an important measure of individual cancer burden and should be considered for funding allocation. Within all cancer sites, there is a significant trend towards rising industry and other funded trials and a trend towards decreasing or stagnating number of public funded studies. This data can be used to investigate reasons for the differential allocation of resources regarding clinical trial initiation.