Disparities in cancer clinical trial participation persist, worsened during pandemic
Click Here to Manage Email Alerts
Key takeaways:
- Cancer clinical trial participation appeared lowest for Black and Latinx patients.
- Clinical trial participation inequities between Black and white patients appeared to increase during the COVID-19 pandemic.
Cancer clinical trial participation appeared lower among Black and Latinx patients compared with white patients with various cancer types, according to study results published in JAMA Network Open.
The findings indicate a need for regulatory guidance to improve diversity in cancer clinical trials, researchers concluded.
Rationale and methodology
“This research was prompted by the FDA draft guidance released in April 2022 that emphasized the need to enhance the inclusion of historically underrepresented racial/ethnic populations in clinical trials,” Gregory S. Calip, PharmD, MPH, PhD, pharmacoepidemiologist and biostatistician specializing in hematology/oncology and cancer health equity research at Flatiron Health, told Healio.
“Previous research has highlighted racial/ethnic inequities in clinical trial participation. Still, these studies typically relied on enrollment data from published trials, which often lack information on patients who were eligible but never recruited or enrolled. In addition, there has been limited research examining the extent to which racial/ethnic inequities in clinical trial participation persisted during the COVID-19 pandemic.”
Calip and colleagues sought to examine racial and ethnic inequities in oncology clinical trial participation among 50,411 patients (57.3% women) with advanced non-small cell lung cancer (n = 20,961), metastatic colorectal cancer (n = 10,596), metastatic breast cancer (n = 9,912), multiple myeloma (n = 4,348) or metastatic pancreatic cancer (n = 4,594) before and during the COVID-19 pandemic, between Jan. 1, 2017, and June 30, 2022.
Black patients had a median age of 65 years, patients identified in the study as Latinx had a median age of 64 years and white patients had a median age of 68 years.
Researchers assessed clinical trial participation overall and by cancer type and period of diagnosis between 2017 and 2019 vs. between 2020 and 2022. They used stratified cause-specific hazard models to estimate adjusted HRs and 95% CIs for likelihood of participation. Oncology trial participation served as the main outcome.
Findings
Overall, clinical trial participation appeared lowest for Black patients (4.4%) and Latinx patients (4.2%) compared with white patients (7.2%) between 2017 and 2022.
Researchers observed inequities in clinical trial participation across all five cancer types, with the most significant observed in metastatic pancreatic cancer among Black (HR = 0.54; 95% CI, 0.36-0.81) and Latinx patients (HR = 0.46; 95% CI, 0.27-0.77).
Clinical trial participation inequities between Black and white patients increased among those diagnosed during the COVID-19 pandemic era (between 2020 and 2022; HR = 0.49; 95% CI, 0.4-0.6 vs. HR = 1; 95% CI, 0.93-1.09) compared with those diagnosed prepandemic (between 2017 and 2019; HR = 0.61; 95% CI, 0.53-0.7 vs. HR = 1).
Limitations of the study included potential underrepresentation in trial accrual, and results may be an underestimation of the inequities in participation among Black and Latinx patients, researchers noted.
Implications
The results further support the FDA draft guidance and recent legislation mandating diversity plans for study sponsors to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials, Calip told Healio.
“With mounting evidence of widening racial and ethnic inequities in health care access and outcomes, particularly exacerbated by the COVID-19 pandemic, it is essential to understand whether these inequities in oncology clinical trial participation have persisted in recent years,” he said. “Opportunities exist for digital tools and real-world data from clinical practice to potentially reduce the diversity gap between the population of patients that will eventually receive novel cancer treatments and those that are eligible and are subsequently enrolled in clinical trials.”
These findings “are important to consider in light of the recent guidance from the FDA directing industry sponsors to proactively implement trial-specific plans for improving representation,” according to an accompanying editorial by Joseph M. Unger, PhD, SWOG Cancer Research Network health services researcher and biostatistician at Fred Hutchinson Cancer Research Center.
“As suggested by this passage, disparities in access to clinical trials span a broad spectrum of sociodemographic domains that likely, commonly, overlap,” Unger wrote. “If so, positive steps to alleviate racial and ethnic enrollment disparities may have the salutary benefit of beginning to resolve disparities for other domains as well. Taken together, these actions could speed the evolution of clinical trial conduct in the U.S. toward the ultimate goal of an inclusive system easily accessible to patients with cancer of any background.”
References:
- Pittell H et al. JAMA Netw Open. 2023;doi:10.1001/jamanetworkopen.2023.22515.
- Unger JM, et al. JAMA Netw Open. 2023;doi:10.1001/jamanetworkopen.2023.22436.
Perspective
Back to Top
Tiffany Onger, MD
This study sheds light on persistent racial and ethnic disparities in cancer clinical trial participation, underscoring the urgent need for regulatory interventions and systemic changes.
The research, prompted by the FDA's draft guidance emphasizing the inclusion of historically underrepresented racial/ethnic populations, examined data from over 50,000 patients with various cancers between 2017 and 2022. The findings are alarming: Black and Latinx patients exhibited significantly lower participation rates compared with White individuals across different cancer types. Most notably, inequities were stark in metastatic pancreatic cancer. Even more concerning is the revelation that these disparities worsened during the COVID-19 pandemic, indicating a troubling trend.
This study underscores the critical importance of addressing these disparities promptly; however, the findings are a downstream demonstration of failure of the system at multiple time points. Clinical trial development must include diverse populations from the outset. This includes community members — such as patient advisory boards — participating and contributing equally in the development of the clinical trial with the principal investigator. Further, diversity within the clinical trial development team — including the principal investigators, research nurses and internal review board (IRB) committee members — is essential. Building diversity into every step of trial development allows opportunity for the development of trials that are of interest to the target population and is much more likely to be successful in recruitment of said population.
The FDA's recent guidance and legislation mandating diversity plans mark positive steps, yet continuous efforts are essential. Diversifying all clinical trial aspects, from development to enrollment, is crucial. Integrating diversity enhances trials' appeal to the target population, increasing successful recruitment. Addressing these disparities not only impacts clinical trials but can catalyze change across health care, fostering an inclusive system. The study's findings are a call to immediate action, demanding accessible advancements in cancer treatments for everyone, irrespective of race or ethnicity.
Collapse
Click Here to Manage Email Alerts