Diversity in clinical trials is now mandated by law. While the importance of study diversity has long been emphasized, this marks the first time it has been codified into law under the Food and Drug Omnibus Reform Act of 2022 (FDORA).1 Through diversity action plans,…
In January 2024, I wrote about the FDA’s then-pending clinical research diversity requirements. Since that time, the regulatory landscape has shifted dramatically. This update outlines the most recent developments—including federal mandates under the Food and Drug Omnibus Reform Act (FDORA), the status of the FDA…
Effective clinical trial project managers do more than just keep tasks on schedule; they play a crucial role in ensuring project success and operational efficiency. Organizations that adopt project management practices achieve a 92% success rate in meeting their project goals and experience 28 times…
Changes taking place in the United States and internationally may affect the clinical trials landscape in the months and even years to come. Here are a few observations: FDA The U.S. Department of Health and Human Services is reducing its workforce and streamlining its functions.…
Creating materials for pediatric participants, whether in digital or printed formats, presents unique challenges. This is due to the need to communicate complex ideas in simpler terms as well as create documents that appeal to that audience. Read on for tips to engage pediatric participants…