Login to Access Video or Poster Abstract: MP32-06
Sources of Funding: 1. The Center for Healthy African American Men through Partnerships (CHAAMPS). NIH grant no. U54MD008620. _x000D_ _x000D_ 2. University of Minnesota Program in Health Disparities Research (PHDR)_x000D_ _x000D_ 3. Masonic Cancer Center

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.

Funding

1. The Center for Healthy African American Men through Partnerships (CHAAMPS). NIH grant no. U54MD008620. _x000D_ _x000D_ 2. University of Minnesota Program in Health Disparities Research (PHDR)_x000D_ _x000D_ 3. Masonic Cancer Center