Men and the elderly may be underserved in cancer clinical trial enrollment, according to a new study from Advocate Aurora Research Institute that looked at the gender, age, race, ethnicity and socioeconomic status of research participants in Wisconsin.
But analysis of the data found no inequities in cancer clinical trial participation across races and ethnicities.
Advocate Aurora Health researchers recently published their findings in the journal Contemporary Clinical Trials.
The investigators analyzed 772 patients participating in National Cancer Institute (NCI) trials among 40,000 patients with cancer in the Aurora Cancer Registry. The project was initiated to evaluate patient participation in Advocate Aurora Health’s National Cancer Institute (NCI) Community Oncology Research Program (NCORP).
“As a high-accruing NCORP site, NCI challenged us to accrue diverse populations to NCI clinical trials,” said oncologist Thomas Saphner, MD, the study’s lead author and co-principal investigator of Advocate Aurora’s NCORP. “This project was initiated to determine if different demographic and socioeconomic groups could be identified and to evaluate whether Advocate Aurora is adequately accruing clinical trial participants from all of those different groups.”
Research Institute co-authors include Andy Marek, manager of research analytics, Jennifer Homa, biostatistician, and Neha Glandt, NCORP administrator, as well as Lisa Robinson, director of Aurora Clinical Data Registries. Michael Thompson, MD, PhD, Advocate Aurora NCORP co-principal investigator, and Karen Cheek, RN, oncology clinical trials manager, were collaborators.
The researchers aggregated patients by four demographic characteristics – age, race, ethnicity and sex – and seven socioeconomic groups based on the census block in which each person lived. For each of the 11 groups, the researchers looked at NCORP accrual information and compared that to cancer patients in the same group who had not participated in clinical trials.
The study found that only 38.3% of patients with cancer who were age 65 and older participated in clinical trials, compared to 61.7% of patients younger than age 65.
“These findings are consistent with every other study published,” the authors wrote. “Cancer is a disease of the elderly and this suggests that there are opportunities for geriatric studies and studies with entry criteria designed to include the elderly at our institution.”
The study also found that only 37.6% of men with cancer participated in clinical trials, compared to 62.2% of women with cancer.
Discrepancies on accrual between men and women were explored further. Although male and female accrual were comparable, a large number of accruals to breast cancer clinical trials appeared to account for greater accrual of women. The researchers also evaluated accruals to clinical trials specifically for cancers found in both sexes. In these clinical trials, the data demonstrated higher accrual for men than for women.
“This information could be interpreted to mean that breast cancer trials accrue well and we should continue to focus on breast cancer trials,” Dr. Saphner said. “An alternative conclusion may be that there may be opportunities to accrue more older men, possibly to prostate cancer trials.”
Race and ethnicity were not statistically significant factors in clinical trial participation in univariable analysis. The study authors found this to be in line with prior research. Six of the seven socioeconomic groups demonstrated statistical significance in single variable analysis, but none of them were significant in multivariable analysis. This was the first report of trial participation analyzed by socioeconomic data determined by census tract.
Overall, the researchers found that the effects of both demographic factors and socioeconomic status accounted for only a small part of the variability in trial participation. The authors state that balanced trial participation is of paramount importance even if demographic and socioeconomic factors are not highly predictive of trial participation.
“This study truly reflects the impact collaboration can have,” said Amit Acharya, PhD, chief research officer and system vice president for Advocate Aurora and the Research Institute. “The team’s work highlights a key topic of equity in clinical trials and can help us establish a more effective clinical trial portfolio across our health system.”
Advocate Aurora is one of 32 health systems fully participating in NCORP, which brings clinical cancer trials to people in their own communities instead of only at major research institutions. Conducting clinical trials in a range of communities small and large means that a more diverse patient population can participate. This expanded access to clinical trials, in turn, generates more broadly applicable evidence that contributes to improved patient outcomes and a reduction in cancer disparities.
Currently, Advocate Aurora NCORP is enrolling participants in approximately 80 NCI clinical trials across its 30 community cancer clinics in Illinois and Wisconsin.
To learn more about Advocate Aurora’s research, visit aurora.org/research.