Jia Liu: Ensuring sponsors enrol patients on trials with diversity in sex, age, ethnicity and race

Jia Liu, Translational Researcher at The Kinghorn Cancer Centre, shared a post by FDA on LinkedIn, adding the folllwing:

“Great to see FDA taking leadership to ensure sponsors enrol patients on trials with diversity in sex, age, ethnicity and race into consideration so that trial populations are more representative of the populations the drugs will hopefully be approved in.

But what about regional/rural location of residence and health literacy?

All these factors should be discussed with sites at feasibility and a plan implemented to facilitate sites to enroll patients particularly from disadvantaged populations.”

Quoting FDA’s post:

“FDA published a draft guidance, ‘Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies‘

This draft guidance describes:

• Format and content of Diversity Action Plans
• The medical products and clinical studies for which a Diversity Action Plan is required
• Timing and process for submitting Diversity Action Plans to the FDA
• Waiver requests

To learn more about this guidance and how to submit comments, visit here.”

Source: Jia Liu/LinkedIn and FDA/LinkedIn
.