July 1st 2025
How clinical operations teams can close the gap between controlled trial results and real-world adoption by generating evidence in broader, more representative patient populations.
Just the Beginning of Improving Diversity Initiatives in Clinical Trials
November 5th 2024In this video interview, Jay Park, founder & scientific lead; and Rebecca Metcalfe, principal scientist, patient-centered research; both with Core Clinical Sciences, share their reactions to the FDA releasing its Diversity Action Plan Guidance.
Vabysmo Shows Significant Vision Improvement for Diabetic Macular Edema in Underrepresented Patients
October 22nd 2024Phase IV ELEVATUM trial results show that one year of treatment with Vabysmo significantly improved vision in underrepresented racial and ethnic groups with diabetic macular edema, supporting the drug's efficacy and safety across diverse populations.
Potential Challenges with FDA’s Multiregional Clinical Trials Guidance
October 14th 2024In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, touches on challenges that may be created by the guidance such as meeting multiple regulatory requirements.
Ensuring Greater Access and Diverse Patient Populations
October 10th 2024In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, highlights how FDA’s multiregional clinical trials in oncology guidance encourages more diverse site locations and patient populations.
New Survey Uncovers Distrust as Key Factor in Enrollment Declines Among Black Patients
October 2nd 2024Findings from two Baltimore medical centers presented at the American Society for Radiation Oncology Annual Meeting suggest spiritual themes and distrust may be behind the decline in trial participation.