The U.S. FDA is implementing policies to eliminate health disparities in clinical trials, research, and treatments of chronic, debilitating diseases. The agency published guidance on the collection of race and ethnicity data in clinical trials, and recently created a Minorities in Clinical Trials Initiative to increase patients’ understanding of the benefits of clinical research. (Health IT Analytics)
Bias in referral to Phase 1 cancer studies
This case-control registry study in Denmark found that novel anticancer therapies seemed to be tested on a socially selected group of patients with cancer. Patients with long distance to the Phase 1 unit, less education, and belonging to the lowest income quintile were less likely to be referred to Phase 1 trials. (PubMed)
How to increase the number of women in CV device trials?
Although the prevalence of cardiovascular disease (CVD) is similar for men and women, men comprise 70% to 80% of enrollees in CV device trials. A new position statement published in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions issued a call to action to multi stakeholders to halt the perpetuating cycle of female underrepresentation in CV studies. (Healio)
Infographic: Women in clinical research through the years
Women have seen deficits and gains in their attempts to be included in clinical research, but as 2019 approaches equality seems forthcoming. (Outsourcing-Pharma.com)
Adolescents, young adults excluded from oncology trials
In Europe, there are barriers to the inclusion of 12- to 25-year-olds in both adult and pediatric early phase clinical trials. A recent study in France found that only 15% of early phase trials for cancer included teenagers between 12 and 17 years of age. The legal minimum age to participate in adult clinical trials in Europe is 18 years; the authors suggest that such “arbitrary age limits” be eliminated. (MedicalXPress)
Older patients and women underrepresented in heart failure trials
Despite the importance of age, gender, and race/ethnicity representativeness in clinical trials, limited data exist regarding the enrollment trends of these groups in heart failure trials. A systematic search of contemporary heart failure trials found that older patients and women are consistently underrepresented (women were 27%), but the enrollment of nonwhite patients increased over time.
HIV patients w/cancer less likely to receive appropriate care
Results from a survey of U.S. oncologists suggest that patients with cancer and HIV are not likely to receive optimal cancer care that takes into consideration their HIV status. Seventy percent of oncologists said that sufficient guidelines for treating these patients were not available; part of the problem is that patients with HIV are often excluded from cancer clinical trials, leading to a gap in knowledge about these patients.
“Vulnerable populations” interested in participating in clinical trials, but left out of the information chain
Vulnerable populations, including racial and ethnic minority groups and individuals with low socioeconomic status, are underrepresented in clinical trials and biobanking. Focus groups among vulnerable populations found they were interested in participating in clinical trials, but lacked information and faced other barriers precluding their participation. (cure)