In the last several decades, public health research has illuminated the considerable racial and ethnic disparities in the diagnosis, treatment, and outcomes of many cancers. In fact, as of 2017, the cancer-specific mortality rate for Black men and women was 24% and 14% higher, respectively, compared to white men and women.
This is particularly notable among gastrointestinal (GI) cancers, which include pancreatic, esophageal, colorectal, liver, and stomach cancer. For example:
While some progress has been made to address the disproportionate burden of cancer in racial and ethnic minority groups, there is much work to be done. Across health conditions, Black, Latinx, and Native American populations generally face greater limitations in access to high-quality healthcare, more exposure to environmental and occupational risk factors for cancer, and other burdens that increase risk and limit care. The systemic drivers of health inequity are vast and will take significant time and dedication to unravel. However, as an industry, there is a clear step forward we can take: improving representation in clinical trials. In fact, better clinical trial diversity and representation is essential if we’re to ensure that GI treatments and interventions are effective for all patients.
In 2017, federal guidelines required that clinical trial results submitted to ClinicalTrials.gov had to report race/ethnicity data… if it was collected. However, as of 2021, 8.6% of trials on the site reported that race/ethnicity data was not collected. This is a major oversight in ensuring that clinical trial findings are representative and applicable to the populations affected by diseases.
While the industry is more aware of the racial and ethnic disparities in the prevalence of cancers, efforts to improve demographic representation in clinical research have not caught up. For example, the FDA approved 81 oral anticancer drugs between 2009 and 2019. Of the 142 clinical trials referenced in these approvals, only 52% even reported patient race and ethnicity data. We cannot hope to fix what we are not measuring.
Trial sites and sponsors need a higher-level view of patient demographic data throughout the clinical trial process to know where to take action. StudyTeam® empowers sites and sponsors to zoom in on gaps in representation early and often.
Diversity reporting capabilities in StudyTeam for Sponsors gives sponsors an understanding of who makes it into the recruitment funnel, who ultimately enrolls, and what happens in between – with insights categorized by race and ethnicity. This diversity view in StudyTeam provides a standardized and transparent means of seeing who is being contacted, screened, and registered for trials, and where efforts to reach certain groups are falling short.
Are patients of a certain racial or ethnic category less likely to meet inclusion and exclusion criteria than others? Are there specific criteria responsible for this? What reasons do eligible patients cite for not enrolling in the trial, and does this vary by race or ethnicity?
By aggregating these insights into the StudyTeam platform from day 1 of the recruitment process, as soon as sites begin to enter pre-screening data, sites and sponsors can take action earlier in the trial timeline to effectively reach patient populations rather than waiting to see if diversity goals are met on time.
Despite facing a greater risk of these diseases, minority populations are often drastically underrepresented in GI clinical trials for cancers, potentially limiting the ultimate applicability of new therapies. Dedicated efforts to increase clinical trial representation and participation are needed. StudyTeam’s diversity reporting capabilities gives sponsors a deeper, more comprehensive view of where and why certain groups of patients are more likely to fall out of the recruitment and enrollment funnel.
It’s hard to solve a problem without measuring it, and this tool provides insights into key metrics that can inform how stakeholders take action.