25 Oct 2021
Posted in Pharma
Improving diversity in clinical trials ensures public health strategies are appropriately tailored to all populations, says GlobalData
Data presented at the 14th AACR* Conference in early October revealing that black patients were significantly more likely to be excluded from pancreatic clinical trials than white counterparts is unfortunately not the only instance of this occurring, says GlobalData. The leading data and analytics company notes that there is an ever-growing concern of ethnic disparity in clinical trials, as recently seen in COVID-19 research.
Alice Beckley, PhD, Senior Oncology and Haematology Analyst at GlobalData, explains: “Racial disparity exists way beyond oncology, and can be seen in many areas of healthcare management. For example, there was a disparity in COVID-19 research among the Black, Asian and minority ethnic (BAME) people. This contributed to devastating results: GlobalData epidemiologists reported that patients with black ethnicity had the highest death rate due to COVID-19, with 62 deaths per 100,000 black population reported in the US and 41 deaths per 100,000 black population reported in the UK. Such examples highlight the need for improved clinical trial recruitment and the pressing issue of regurgitating historic eligibility criteria that have no clear scientific or clinical rationale.”
Race and ethnicity are taken into account in clinical trials because these aspects do contribute to interindividual differences to drug exposure and response. The risk-benefit ratio is, therefore, altered in specific populations. However, inadequate clinical trial representations of all populations can leave excluded patients vulnerable as there will be a limited risk-benefit assessment in these subgroups.
Beckley continues: “As an example, according to the 2018 national vital statistics report, African Americans were 30% more likely to die from heart disease than non-Hispanic whites in cardiology. Although it has been generally reported that heart conditions disproportionately affect black patients, due to a higher prevalence of risk factors in that group, it is yet to be appropriately recognized during clinical trial recruitment. The FDA’s global participation in clinical trials report found that African Americans only accounted for 2.5% of cardiology clinical trial participants.”
One noteworthy issue is the compliance of patients with underlying infectious diseases. Patients in these subsets can often take “drug holidays,” whereby the patient stops the therapy for a while due to the fatiguing effect of the comorbidities. “Forgetfulness” is another aspect of non-compliance due to the inundated amount of drugs to be taken by patients to manage their underlying and current disease. At the 14th AACR* Conference, the simulated study excluded 9.06% of black patients versus 3.43% of white patients with hepatitis C. In general, all patients with underlying infectious diseases can be vulnerable to trial exclusion; however, this recent study further highlights the discrepancy in recruitment and the ever-pressing racial bias.
Backley adds: “While compliance is a noteworthy issue, it does not warrant the exclusion of these subgroups, as they may reflect the patient populations that are likely to use a particular drug in clinical practice. Therefore, careful consideration must be taken to widen eligibility criteria in clincial trials to avoid risking patient safety – since the risk-benefit ratio would have been appropriately assessed across all populations that are likely to access the drug.
“Improving diversity in clinical trials ensures that healthcare delivery and public health strategies are appropriately tailored to all populations, as well as maximize the generalizability of trial results and increase clinical knowledge on disease pathophysiology and the range of genetic profiling.”
* American Association for Cancer Research