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)
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)
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)
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.
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)