Demographic diversity of participants in Pfizer sponsored clinical trials in the United States

Rottas, Melinda M.; Thadeio, Peter F.; Simons, Rachel N.; Houck, Raven; Gruben, David; Keller, David; Scholfield, David; Soma, Koshika; Corrigan, Brian; Schettino, Annette; McCann, P.J.; Hellio, Marie-Pierre; Natarajan, Kannan; Goodwin, Rob; Sewards, Judy; Honig, Peter K.; Mackenzie, Rod

doi:10.1016/j.cct.2021.106421

Cited by 37 publications

(52 citation statements)

References 5 publications

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“…Multiple authors have written about low participation of racial and ethnic minorities in global clinical trials in comparison with U.S. census data 4 , 5 but very few have actually compared participation in U.S. trials to U.S. census data. 6 Further, to better support the efforts of clinical trial communities to diversify the trial population within the United States, understanding the current rates of participation of racial and ethnic groups within the United States is critical. We have previously published global participation data as a part of the Drug Trials Snapshots initiative; our focus here is therefore on the representation in the U.S. trials.…”

Section: Discussionmentioning

confidence: 99%

U.S. racial and ethnic participation in global clinical trials by therapeutic areas

2021

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What is known and objective The discussion about health equity in the United States frequently involves concerns over racial and ethnic minority under‐representation in clinical trials and particularly in trials conducted in support of product approvals. The FDA has long worked to encourage diverse participation in clinical trials and through its Drug Trials Snapshots (DTS) program, the U.S. Food and Drug Administration (FDA) has moved to make trial demographic data more accessible and transparent. We conducted a demographic study of U.S. participants in clinical trials for FDA‐approved new drugs (new molecular entities [NMEs], and original Biologics License Applications [BLAs]) from 2015 to 2019, as reported in DTS database with a purpose of understanding the extent to which U.S.‐based trials used to support product approvals represent the racial and ethnic diversity of the U.S. population by therapeutic area. Methods Participant‐level trial data were collected by accessing the FDA electronic common technical document (eCTD), for the applications used to publish each Snapshot. The therapeutic area (TA) for each drug was determined by review division assignment. The demographic data were analysed and compared to U.S. census data. Results and discussion We examined 102,596 U.S. participants in trials of new drugs that were approved and presented in Drug Trials Snapshots between 2015 and 2019. White participation ranged from 51% in psychiatric trials to 90% in cardiovascular (CV) trials; Black or African American participation ranged from 5% in medical imaging to 45% in psychiatric trials; Asian participation ranged from 0.75% in CV to 4% in dermatologic trials; and Hispanic or Latino participation ranged from 1% in medical imaging to 22% in infectious diseases and gastroenterology trials. What is new and conclusion Our data showed variable representation of racial and ethnic minorities across therapeutic areas at the U.S. sites. Blacks or African Americans were represented at or above U.S. census estimates across most therapeutic areas, while Asians and American Indian or Alaska Natives were consistently underrepresented. Hispanic or Latino participation across most therapeutic areas was below U.S. census estimates, however, more variable, and a sizable proportion of data was missing. The next step is a comparison of trial participation based on disease prevalence and epidemiology, which is a more accurate assessment of trial diversity.

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Section: Discussionmentioning

confidence: 99%

U.S. racial and ethnic participation in global clinical trials by therapeutic areas

2021

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“…Pharmaceutical and device companies can also be part of the solution-for example by increasing the diversity of investigators and trial populations in clinical trials [79]; by engaging with stakeholders on healthcare policy and access; and by helping to target education to areas and populations with the greatest need.…”

Section: Discussionmentioning

confidence: 99%

Disparities across Diverse Populations in the Health and Treatment of Patients with Osteoarthritis

2021

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The study of disparities across diverse populations regarding the health and treatment of patients with osteoarthritis (OA) is recognized as a priority for investigation and action by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the American Academy of Orthopedic Surgeons (AAOS). OA is a common condition that increases with age, but with prevalence generally similar across racial and ethnic groups. However, disparities in the treatment of OA among racial, ethnic, and socioeconomic groups are well-documented and continue to rise and persist. The reasons are complex, likely involving a combination of patient, provider, and healthcare system factors. Treatment disparities among these different populations have an impact on clinical outcomes, healthcare, and productivity, and are projected to increase significantly with the growing diversity of the United States population. The aim of this short review is to summarize studies of racial, ethnic, and socioeconomic disparities among patients with OA in the United States, with a focus on prevalence, treatment utilization, and clinical and economic outcomes.

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“…Thus, efforts to intentionally increase the proportion of cancer clinical trials for all minorities are needed. According to the FDA ( 76 , 77 ), Asian Americans were consistently underrepresented in clinical trials for all types of therapeutics (2.08%) compared with their representation in the 2015 Census (5.53%). National consciousness to address Blacks and Hispanics, designated as Underrepresented Minorities, is helpful.…”

Section: Underrepresentation In Clinical Trialsmentioning

confidence: 99%

“…Eleven percent of 292 537 Pfizer global trial participants were Asian, highlighting the fact that most Asian clinical trials participants are from studies conducted outside the United States ( 77 ). Global vs US variance fails to account for potential differences in endemic infection rates or vaccination rates for viral-related cancers or for diet or lifestyle differences between Asians in their respective native countries and their Asian American counterparts.…”

Section: Underrepresentation In Clinical Trialsmentioning

confidence: 99%

Charting a Path Towards Asian American Cancer Health Equity: A Way Forward

Chen

Lee

Madan

et al. 2022

JNCI: Journal of the National Cancer Institute

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On July 29, 2021, the US Food and Drug Administration’s Oncology Center of Excellence convened Conversations on Cancer. This Conversation, the first ever by the US Food and Drug Administration, focused on Asian Americans and served as the platform for this Commentary. Panelists elaborated on topics ranging from heterogeneity in Asian American demographics to racism through a path to health equity and supplemented this Commentary with literature citations. Asian Americans are the fastest-growing US race group, yet data aggregation obscures distinctions and cancer disparities within the more than 24 million Asians living in the United States with harmful impacts on communities and patients, as illustrated by breast cancer survivor Susan Shinagawa’s patient-to-advocate journey. Bigotry against Asian Americans has been pervasive since the 19th century, but especially during the COVID-19 pandemic. Asian Americans are unique as the first US population to experience cancer as the leading cause of death. Asian Americans are disproportionately affected by cancers because of infectious origins and have the highest rates of lung cancer among never-smoking women. The infinitesimal proportion of the National Institutes of Health’s budget compared with experiencing the highest percentage increases of any US racial population more than 3 decades highlights the dearth of focused research among Asian Americans. Recognizing the heterogeneity of Asian Americans and that disaggregated data are critical for accurately characterizing distinct ethnic groups, focusing on the impact of racism and COVID-19 on cancer disparities, and focusing and prioritizing funding resources are necessary steps forward for achieving health equity for Asian Americans.

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Demographic diversity of participants in Pfizer sponsored clinical trials in the United States

Cited by 37 publications

References 5 publications

U.S. racial and ethnic participation in global clinical trials by therapeutic areas

U.S. racial and ethnic participation in global clinical trials by therapeutic areas

Disparities across Diverse Populations in the Health and Treatment of Patients with Osteoarthritis

Charting a Path Towards Asian American Cancer Health Equity: A Way Forward

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