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Trends in public- and industry-funded uterine cancer clinical trials and disability-adjusted life years from 2007 to 2019

      Objective

      In 2022, for the first time, uterine cancer (UC) will not only be the most common gynecologic cancer in the United States, but it may also match ovarian cancer in gross mortality.
      • Siegel R.L.
      • Miller K.D.
      • Fuchs H.E.
      • Jemal A.
      Cancer statistics, 2022.
      This is in part owing to a lack of treatment advances in UC.
      • Siegel R.L.
      • Miller K.D.
      • Fuchs H.E.
      • Jemal A.
      Cancer statistics, 2022.
      Gynecologic cancer trials suffer from low accrual
      • del Carmen M.G.
      • Annunziata C.M.
      • Rice L.W.
      The clinical trials crisis in gynecologic oncology.
      and receive significantly less public funding relative to societal burden than most other cancers receive.
      • Spencer R.J.
      • Rice L.W.
      • Ye C.
      • Woo K.
      • Uppal S.
      Disparities in the allocation of research funding to gynecologic cancers by Funding to Lethality scores.
      Most studies that have investigated cancer funding patterns utilize the federal funding data. In this study, we identified the trends in the number of open public- and industry-funded endometrial cancer trials relative to UC’s disease burden.

      Study Design

      We queried ClinicalTrials.gov to obtain the number of open endometrial cancer clinical trials that utilized public and industry funds from 2007 to 2019 in the United States. Public funders include the National Cancer Institute and other federal agencies. Industry funders represent pharmaceutical and device companies. A study is considered open if the date of first enrollment in that year begins between January 1 and December 31. The disability-adjusted life year (DALY) number incorporates the years of potential life lost owing to premature mortality and the years of productive life lost because of disability. DALY has been shown to correlate better with funding decisions than other cancer burden metrics.
      • Gross C.P.
      • Anderson G.F.
      • Powe N.R.
      The relation between funding by the National Institutes of Health and the burden of disease.
      The DALY numbers for UC from 2007 to 2019 were retrieved from the Institute for Health Metrics and Evaluation database.
      Institute for Health Metrics and Evaluation
      GBD compare.
      The ratios of the number of open trials to DALY number per 100,000 people were generated as studies funded by public (#P/DALY) and industry (#I/DALY). Linear regression analyzed the trend lines and rates of change. This study was considered exempt from institutional review board approval.

      Results

      The results are presented in the Figure. From 2007 to 2019, UC’s DALY increased significantly (R2=0.981; P≤.001). The number of public-funded trials did not change (R2=0.072; P=.375), but the number of industry-funded trials rose significantly (R2=0.604; P=.002). #P/DALY showed a negative trend over the study period (R2=0.317; P=.045), reflecting decreases in the number of public-funded studies relative to the rise in DALY. By #I/DALY, endometrial cancer experienced significant increases in industry-funded studies relative to DALY (R2=0.427; P=.015).
      Figure thumbnail gr1
      FigureThe number of public- and industry-funded studies and DALY number per 100,000 people from 2007 to 2019
      The figure illustrates the number of public-funded and industry-funded studies and the DALY number per 100,000 people from 2007 to 2019. It also shows the trend line for the ratios of the number of funded studies over the DALY data evaluated by linear regression over the study period.
      DALY, disability-adjusted life years; #I/DALY, the number of industry-funded clinical trials relative to DALY number per 100,000; #P/DALY, the number of public-funded clinical trials relative to DALY number per 100,000 people.
      Wang. Trends in public- and industry-funded uterine cancer clinical trials and disability-adjusted life years from 2007 to 2019. Am J Obstet Gynecol 2022.

      Conclusion

      The Society of Gynecologic Oncology declared a clinical trial crisis in gynecologic oncology in 2016.
      • del Carmen M.G.
      • Annunziata C.M.
      • Rice L.W.
      The clinical trials crisis in gynecologic oncology.
      The reasons were multifactorial, but a commonality was the paucity of gynecologic cancer trials. Our findings found that, whereas industry-funded clinical trials rose significantly, public-funded trials for endometrial cancer did not increase significantly to reflect the striking rise in UC's societal burden from 2007 to 2019. In fact, relative to DALY, the number of public-funded trials decreased. This suggests that public funding for UC has been disproportionately low, considering its escalating disease burden. The opposite was seen with industry-funded studies. For public funding agencies to continue to meaningfully contribute to UC advancements, greater efforts need to be made to secure funding for clinical trials that is proportionate to its high and worrisome disease burden. Future studies that will additionally evaluate the number of patients enrolled by each funding source and utilize different burden metrics are warranted to investigate this differential allocation of funding resources in gynecologic cancer clinical trials.

      References

        • Siegel R.L.
        • Miller K.D.
        • Fuchs H.E.
        • Jemal A.
        Cancer statistics, 2022.
        CA Cancer J Clin. 2022; 72: 7-33
        • del Carmen M.G.
        • Annunziata C.M.
        • Rice L.W.
        The clinical trials crisis in gynecologic oncology.
        Gynecol Oncol. 2017; 145: 481-482
        • Spencer R.J.
        • Rice L.W.
        • Ye C.
        • Woo K.
        • Uppal S.
        Disparities in the allocation of research funding to gynecologic cancers by Funding to Lethality scores.
        Gynecol Oncol. 2019; 152: 106-111
        • Gross C.P.
        • Anderson G.F.
        • Powe N.R.
        The relation between funding by the National Institutes of Health and the burden of disease.
        N Engl J Med. 1999; 340: 1881-1887
        • Institute for Health Metrics and Evaluation
        GBD compare.
        (Available at:) (Accessed May 28, 2020)