While this week’s news of one major vaccine candidate for COVID-19 having reached the Phase III trials stage with a goal of 30,000 volunteer patients is encouraging in many respects, the specifics about the demographics of trial participants for this and other studies are on the minds of some clinical research stakeholders.
Clinical trials marketplace SubjectWell has been collecting statistics on how race and gender impact clinical trial participation and patient sentiment during the pandemic. The latest findings from a June survey of 553 respondents suggest twice the number of African Americans (26%) versus Caucasians (13%) feel “not at all likely to consider participation in a clinical trial for a condition other than COVID-19.”
Further, 56% of African Americans responded they would be “very concerned about COVID-19 exposure when taking part in a clinical research study” versus 31% of Caucasians.
“The responses to our survey reinforce the fact that serving the needs of a diverse population in clinical trials means understanding the vastly disproportionate impact that COVID-19 is having on Black and Latinx communities,” SubjectWell CEO Ivor Clarke told ACRP. “People of color who are diagnosed with COVID-19 are hospitalized at four to five times the rate of white people, and are 2.5 times more likely to die. Long-standing social and health inequities are being brought into sharp relief as a result of the pandemic, and sites and sponsors should be aware that the ability to offer support services will affect not just overall participation rates, but the demographic composition of their trials.”
SubjectWell’s most recent survey was conducted in partnership with CISCRP, the Center for Information and Study on Clinical Research Participation.
This round of the survey (see rounds 1, 2 and 3), also found that men are less hesitant to participate in non-COVID-19 clinical trials than women, and women have a greater need for safety precautions if they were to participate. Specifically, the report shows that women place a higher value on precautions like being able to communicate with a study doctor remotely, having study medicine delivered to their home, and knowing their health and safety would be protected when visiting the study clinic.
“Having a grasp on these sentiments may now be more important than ever, as states continue the reopening process while positive cases continue to increase,” Clarke wrote in a recent article.
Author: Gary Cramer