GU Cancers 2022 | Disparities in clinical trial participation of ethnic minorities & older adults with prostate cancer

So trials, which recruit primarily younger white males, force us to generalize the treatment effect to the care of women, older adults with cancer, so that compromises the quality of care of these subgroups or minority subgroups, receive for cancer care. And prostate cancer is known to suffer from disparities. We already know that Black men are 1.8 times more likely to be diagnosed with, and 2.2 more likely times to die from the prostate cancer. So what we aim to do was to quantify the enrollment disparities in clinical trials precisely using meta analytic methods, and also study the reporting trends over the last three years in the clinical trials. So what we did was we identified the prostate cancer clinical trials of the last 30 years, and we went and collected data on enrollment of different racial, ethnic categories, older adults. And then we used enrollment incidence ratio to compare the enrollment trends over time and to study how these trends have changed.

We wanted to compare apples with apples, so what we did was we used enrollment incidence ratios. What it does is, it compares the recruitment right in reference to the appropriate incidence of cancer in that particular minority subgroup. And our findings are striking, we already know that disparities exist, but I think what we found was quite enlightening. So we found that, even the reporting about these ethnic minorities and older adults is poor, they’re only less than 10% trials which report data on the racial categories, and only 15% of the trials report data on ethnicity, and only 25% trials report data on older adult’s participation in the clinical trials.

And we found that the participation of Black adults, Hispanics is remarkably low. And especially, I think Black patient, the enrollment incidence ratio was 0.4. And in simple words, if 16 Black patients are expected based on their incidents to be participating in the clinical trials, only 6 were participating, if 9 Hispanic participants were expected to be there, only 4 were there. So you see how little representation these minority subgroups are getting in these clinical trials. We studied the trend over the last 30 years, and we found that the participation of Black participants has significantly declined over time. The participants of Hispanic participants also has decreased, but not as significantly as Black participants. The participation of older adults is slowly edging up, that’s a good sign.

So these findings are a call to action to address the disparities. The finding of low representation of minorities in the clinical trials really reflects the social construct, and the deep existing social disparities. We need to really talk about the issue of equality, equity and reality here. So we need to improve the access of minority patients to clinical trials. When we see them in the clinic, we need to probably spend extra time with them. When we have finished seeing them, probably we need to do a better follow with them. We need to involve patient advocates. We need to restore their trust in the healthcare system. Maybe what we need to do is to focus more on representation of minorities in the healthcare task force. I think lots of great efforts are already underway regarding this effort, but I think we need to do more.

I think one of the key issues is that I think regulatory authorities, industry, patients, healthcare providers, all need to sit together to maybe come up with a plan to ensure that a certain number or a certain percentage of minorities should be recruited in the clinical trials. And we have to do it in a way that doesn’t have a progression. Maybe we could come up with a mechanism in which after the reporting, maybe we sit together and come with the mechanism that doesn’t slow innovation. For instance, you could still design the primary trials to report the primary endpoints, but the trials may continue to recruit certain percentage of minorities even after that, to ensure that there is generalizability of these results to the minority populations.