Tag: DEI 6 results

Clinical Development

Art as a Catalyst: Reflections Transforms Clinical Trial Awareness in the Community

In the world of clinical research, diversity, equity, and inclusion (DEI) are not just buzzwords—they are essential pillars for advancing healthcare outcomes for all populations. Historically, clinical trials have often lacked diversity, leading to data gaps that can impact the effectiveness of treatments for underrepresented communities. Increasing access to clinical research is crucial not only…

Clinical Development

FDA’s Diversity Mandate: Transforming Clinical Trials and Drug Development for Better Outcomes for All

On June 26, 2024, the U.S. Food and Drug Administration (FDA) released its much-anticipated draft guidance on clinical trial diversity.1 This 23-page document outlines proposed requirements for racial and ethnic diversity action plans, which will soon become mandatory for studies involving drugs, devices, and other medical products. In this article, we highlight the key provisions…

Clinical Development

Advancing Health Outcomes for All: Addressing Diversity and Ethnicity Data Challenges in Global Clinical Research

In the business of pharmaceutical and MedTech clinical development, the significance of robust data cannot be overstated. It serves as the cornerstone for informed decision-making and cultivates an environment where innovation thrives. However, when confronted with the task of comparing ethnicity data across diverse countries, a myriad of challenges and intricacies surface, warranting a thorough…

Clinical Development

4 Steps to Implementing DEI in Clinical Trial Design and Patient Recruitment

Welcome to part two of our blog series focused on the integration of diversity, equity, and inclusion (DEI) into clinical research. If you missed part one of the series that highlights recent FDA initiatives and legislative changes behind these developments, click here. In today’s clinical research environment, sponsors face the challenge of comprehensively incorporating DEI…

Clinical Development

FDA’s Push for DEI in Clinical Trials: What Sponsors Need to Know in 2024

In the ever-evolving field of global clinical research, the integration of diversity, equity, and inclusion (DEI) has become a pivotal focus, especially considering recent FDA initiatives and legislative changes. The U.S. Food and Drug Administration’s (FDA) ongoing efforts, coupled with the enforcement of the DEPICT Act and impending final regulatory guidance, highlight the urgency and…