Poster, Podium & Video Sessions
Presentation Authors: Koushik Paul*, Chap Le, Badrinath Konety, Minneapolis, MN
Introduction: We sought to compare if accrual difficulties are unique to urologic cancer trials compared to other solid organ tumor trials. We also sought to assess the extent to which race/ethnicity is reported in both urologic and non-urologic cancer trials.
Methods: We analyzed online data for all phase III/IV trials from clinicaltrials.gov and the ISRCTN registry for prostate, bladder, kidney, colorectal, breast, and lung cancer. All closed therapeutic and non-therapeutic trials between 2000-2016 were included. For the selected trials, information about accrual sufficiency, age group, allocation, funding, gender, intervention model and type, masking, organ site, primary purpose, race/ethnicity reporting, trial duration, and trial phase were collected. Accrual sufficiency and race/ethnicity reporting by cancer type was determined. Chi squared and logistic regression analyses were used to determine factors associated with accrual sufficiency and minority enrollment.
Results: 326/658 (49%) clinical trials identified met our selection criteria. Data from 234/326 (71.8%) of the trials were cross-verified using peer-reviewed publications. Accrual sufficiency overall was 62%, with kidney cancer reporting the highest (79%) and bladder cancer trials reporting the lowest (50%) accruals. 57% of the trials reported race and ethnicity in their analysis with lung cancer trials reporting the highest (68%) and bladder cancer trials reporting the lowest (30%). Non-urologic (77%) trials reported higher race/ethnicity reporting than urologic (23%) trials (p<0.01). Factors associated with accrual sufficiency included funding source (p=0.01) and gender (p=0.03). Government funded trials involving women were associated with better accrual. Factor associated with minority enrollment include trial phase (p=0.03). Factors associated with reporting of African-American enrollment include allocation (p=0.03), funding source (p<0.01), and intervention model (p=0.04). Government funded trials, non-randomized trials, and cross over trials were associated with higher levels of reported African American enrollment.
Conclusions: Clinical trial accrual is low, raising questions about the statistical validity of results from trials with incomplete accrual. Overall race/ethnicity reporting in trials remains low, specifically in urologic trials. Government funded trials appear to perform better on both these aspects. This makes it difficult to generalize results from large trials to minority populations, especially using data from industry-sponsored trials.
Source Of Funding: 1. The Center for Healthy African American Men through Partnerships (CHAAMPS). NIH grant no. U54MD008620.
2. University of Minnesota Program in Health Disparities Research (PHDR)
3. Masonic Cancer Center
University of Minnesota Duluth
Koushik Paul is a senior at the University of Minnesota Duluth majoring in Biochemistry and American Indian Studies. He currently works at the Research for Indigenous Community Health (RICH) Center as an Undergraduate Research Assistant on projects to address health disparities prevalent in the American Indian population. Last summer Koushik completed the prestigious Cancer and Health disparities research internship at the University of Minnesota Medical School under the mentorship of Dr. Badrinath Konety, Department Chair of Urology. He invesitgated variations in accrual and race/ethnicity reporting in urology and non-urology related cancer trials and will be presenting the results of this study at this year's annual AUA meeting. Koushik is applying to medical school next year with the hopes of becoming a physician who will serve the needs of underserved communities in culturally responsive ways through service and community engaged research.
Saturday, May 13
9:30 AM – 11:30 AM