Phesi Inc. has recently analyzed protocol design data from 1,324,820 US patients, from Phase II and III single country clinical trials across a total of 1,580 cohorts. This data set represents 495 disease conditions with trials starting from 2010-2020. The results showed that Asian, Hispanic and Latino, Native Americans and Alaska natives, Native Hawaiians and other Pacific Islander patient subpopulations were all significantly and consistently underrepresented over the decade.
The data show Black and African American patients appear to have become better represented over the past decade, making up 14.92% of the data set, compared to 13.4% of the total US population in 2019 US Census Bureau estimates. This positive change is due to concentrated efforts from industry to improve racial diversification, as well as vital work undertaken by patient advocacy groups for diseases disproportionally impacting Black/African Americans in the US. This is a broad snapshot over trials over the last decade and the increased numbers do not mean the work to ensure true representation of Black/African American participants in clinical trials is done. Moreover, other racial groups are still markedly underrepresented in trials.
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.