Boston, MA-- Clinical trials can offer patients access to cutting-edge treatments with the potential to extend their survival and shape the standard of care in the future. As of last year, more than 400 prostate cancer clinical trials were being conducted to find interventions to extend the lives of patients. Despite the fact that black men face higher rates of prostate cancer and are more at risk of dying from the disease, black patients are underrepresented in clinical trials. A team of investigators from Brigham and Women's Hospital studied a potential barrier that may be disproportionately preventing black patients from enrolling in these trials: lab test results. They found that more than half of the studies conducted used laboratory values that varied by race, disproportionately excluding black men. Their results are published in JAMA Oncology.
"Something as simple as a lab-value exclusion criteria may serve as yet another barrier to allowing African-American patients to take part in randomized trials," said corresponding author Paul Nguyen, MD, of the Department of Radiation Oncology at BWH. "We hope that this message will reach researchers who are designing clinical trials and setting entry criteria: we need to be cognizant that the criteria we choose may inadvertently make it harder for African-American patients to participate."
Lead author Marie Vastola, a research assistant in Radiation Oncology at BWH, and colleagues examined a list of 401 prostate cancer clinical trials collected from clinicaltrials.gov and investigated the use of serum creatinine (sCr) and absolute neutrophil count (ANC) to determine a patient's eligibility for the trial. sCr is used as a measurement of kidney function, but varies by race - black patients tend to have higher sCr concentrations than white patients or patients of other races or ethnicities. ANC is measured to determine the health of a patient's immune system. But up to 8 percent of black patients may have benign ethnic neutropenia, a condition that decreases ANC levels but does not affect the immune system. Without adjusting for race, both measurements may disproportionately exclude black patients from a clinical trial.
The team found that 47.9 percent (192) clinical trials used either sCr alone and/or required participants to have an ANC of 1.5 x 109 cells/L or higher, criteria that disproportionately excluded black patients.
"Adjusting for race-based differences in clinical trial eligibility criteria may add slight logistical challenges, but these adjustments could prevent qualifying individuals from being excluded from trials solely because of laboratory differences caused by their race," said Vastola.
This study was supported by the Prostate Cancer Foundation and Wood Family Foundation.
Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 4.2 million annual patient visits and nearly 46,000 inpatient stays, is the largest birthing center in Massachusetts and employs nearly 16,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Brigham Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 3,000 researchers, including physician-investigators and renowned biomedical scientists and faculty supported by nearly $666 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative as well as the TIMI Study Group, one of the premier cardiovascular clinical trials groups. For more information, resources and to follow us on social media, please visit BWH's online newsroom.
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