Cancer clinical trials have become more diverse during past 2 decades
Click Here to Manage Email Alerts
Key takeaways:
- Trial enrollment more than doubled among those aged 75 to 84 years between 2000 and 2022.
- The proportion of Black, Hispanic/Latino and Asian/Pacific Islander participants increased during the study period.
A greater proportion of older patients and individuals from historically underrepresented groups participated in NCI-funded early-phase cancer clinical trials in 2022 compared with 2000, according to study results.
The findings — presented during the American Association for Cancer Research Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved — additionally suggest outreach and inclusion efforts for enrollment of underrepresented patients should continue to sustain the observed trends, researchers concluded.
Rationale and methods
“Early-phase clinical trials, which primarily evaluate the safety of new therapies, have historically had insufficient representation of racial minorities, women, elderly patients, and people from lower socioeconomic strata, among other groups,” Maria Farooq, MBBS, clinical fellow at NCI, told Healio. “This has limited the generalizability of trial results and increases the chance that important safety issues might be missed, which could further widen disparities in health care outcomes. The lack of diversity in early-phase clinical trial accrual also limits underrepresented patients’ access to cutting-edge therapies only available in the clinical trial setting.”
Farooq and colleagues sought to assess trends in early-phase clinical trial accrual. They gathered data on 14,877 patients enrolled in NCI Cancer Therapy Evaluation Program-sponsored phase 1, phase 1/ phase2 and phase 2 oncology clinical trials conducted between 2000 and 2022.
Findings
Results showed the proportion of patients aged between 40 and 64 years at clinical trial enrollment decreased from 59.8% between 2000 and 2003 to 47.5% between 2020 and 2022.
Researchers observed an increase in enrollment among those aged 65 to 74 years from 24.2% between 2000 and 2003 to 32.9% between 2020 and 2022, and an increase among those aged between 75 and 84 years from 5.9% to 12.3%.
Results also showed a decrease in the proportion of white patients enrolled in clinical trials, from 83.7% between 2000 and 2003 to 72.9% between 2020 and 2022.
Conversely, clinical trial enrollment increased among Black patients from 6.3% between 2000 and 2003 to 7.1% from 2020 and 2022. Likewise, enrollment increased during the study periods among Hispanic/Latino (from 4.2% to 6.9%) and Asian/Pacific Islander (from 2.5% to 5.4%) participants.
Moreover, researchers observed shifting trends in clinical trial enrollment according to geographic regions, with an overall increase in enrollment in the South from 29.1% between 2000 and 2003 to 40.9% between 2020 and 2022, and in the West from 7.9% to 18.2%. Clinical trial enrollment in the Northeast remained somewhat static, decreasing slightly from 23.9% between 2000 and 2003 to 20.8% between 2020 and 2022, while enrollment decreased in the Midwest from 24.4% to 19.4%.
Of note, researchers observed an overall increase in patients who enrolled within a 50-mile radius of their residence during 2000 to 2022 from 46.5% to 64.5%, and an overall decrease in patients who enrolled within a 200-mile radius from 16.1% to 8.3%.
Researchers acknowledged multiple study limitations, including the inability to draw any conclusions about the causes of the trends due to the observational nature of the study, and the possibility that the observed changes may have been influenced by changes in the cancer types and investigational therapies studied during each period.
Implications
“[During] the period evaluated, NCI-sponsored early-phase cancer clinical trials became more representative of the broader patient population. These results are encouraging, but there is still substantial room for improvement in this area," Farooq told Healio.
“While the study did not examine the underlying factors influencing the observed trends, we speculate that the greater number of early-phase clinical trials, changes to eligibility criteria and an increase in the number of small sites offering clinical trials may have contributed to the increased diversity of clinical trial participants in recent years,” she added. “Broadly, we believe that further increasing outreach and accessibility to marginalized communities, as well as strengthening trust between these communities and research institutions, may continue to improve enrollment diversity now and in the future.”
Collapse
Farooq M, et al. Trends in disparities in clinical trial accrual: An analysis of National Cancer Institute (NCI)- sponsored early phase clinical trials over the last 22 years. Presented at: AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Sept. 29-Oct. 2, 2023; Orlando.
Read more about
Click Here to Manage Email Alerts