With the recent updated FDA guidance on Clinical Trial Diversity - the one thing that stands out for me is the need for DATA. Data Sources, Data Access, Data Quality. Your Epidemiology plan needs to be Data Driven. You will need to have a robust data source of the highest Quality - the FDA WILL review this. You will need to include an overview of your Patient Engagement and Recruitment Strategy - and this has to involve appropriate site selection with a patient community that supports your desired real-world population. Finally, don't forget, it's not just about Age, Ethnicity, Sex, Race........ When we create offerings @Citeline, we ensure they solve a genuine industry need. #FDA #Diversity #ClinicalTrials #Data #Citeline
With the FDA's recent updated guidance, the need for a robust diversity plan has never been greater. Hear Citeline's Claire Riches share insights about Global Patient Insights, the industry’s most comprehensive view of the worldwide patient landscape, helping you easily locate sites with clinically relevant and diverse patient populations. Learn more: https://ow.ly/Wjpe50SCgLX.