The new FDA guidance to enhance diversity in clinical research subjects has brought ethnic and racial diversity to the center stage for sponsors. In this document, the FDA encourages sponsors to develop a Race and Ethnic Diversity Plan to incorporate into each protocol. More specifically, the FDA suggests that to achieve these diversity targets, sponsors...
Recruitment & Diversity
Enrollment is critical to a trial, and site performance is a major – if not the most important – driver of that. We’ve always known that our full stack system enables sites to increase efficiency and enhance data quality, but do sites who use CRIO actually enroll more? We now have data to prove that...
Recruitment & Diversity
Overview This past April, the FDA released updated guidance to sponsors and pharmaceutical companies on increasing racial and ethnic diversity in clinical trials to propel more inclusive research. Racial and ethnic minorities have historically been underrepresented in research,1 even within diseases where they make up the majority of those affected. The FDA also advises sponsors...
Recruitment & Diversity
We know that clinical research changes are slow since it’s based on practices that require large, established data taxonomies. But at CRIO, we encourage pharma companies to adopt more gender-inclusive language. For example, some protocols may require only people assigned to one or the other sex at birth and if so, they should clearly state...
Recruitment & Diversity
In the latest segment of WCG’s COVID webinar series, Ms. Annick de Bruin compares the results of CISCRPs broad annual survey to the results of their new COVID-focused survey. Dr. Edith Mitchell also discusses the disproportionate impact of COVID on people of color and how we can take lessons learned in the pandemic to promote...
