Every year during the month of June, people around the world come together to celebrate pride. Pride month is a time for the LGBTQ+ community and its allies to celebrate their accomplishments throughout history, but also to advocate for what still needs to be done in order to secure full equal rights around the world....
Analyzing the FDA’s Approach to Diversity In Clinical Trials Certain groups remain underrepresented in clinical research. The FDA has taken steps to address inequities in clinical trials by releasing guidance to sponsors and other regulated entities and included steps on how to address gaps in diversity. Diversity in clinical trials is critical because it helps...
Improving patient diversity in clinical trials has been a major initiative by the FDA as evidenced by the 2020 Enhancing the Diversity of Clinical Trial Populations guidance as well as the 2022 Diversity Plans guidance. Many forward-thinking site operators are looking for new ways to access potential study participants that better reflect the population most likely...
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...
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...
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...
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...
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...
