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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.