January 29th 2025
Research from the Tufts Center for the Study of Drug Development’s PACT Consortium shows DCTs encourage higher participation across multiple demographic groups.
Empowering Sites and Patients: The Impact of Personalized Support in Clinical Trials
November 26th 2024To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.
FDA Finalizes Decentralized Clinical Trial Guidance
November 25th 2024The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
In Focus: Addressing the Health Literacy Roadblock in Patient Recruitment
Published: November 15th 2024 | Updated: November 15th 2024With universal adoption of health literacy best practices slow going over the years, advocates are redefining the term to encompass much more of what health-related communication requires beyond simply words.
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.