Kaitlyn D’Onofrio

Urban Health Today

The globalization of cancer clinical trials resulted in fewer Black patients being enrolled, further widening the racial gap in cancer clinical trials, a study suggests.&ldquo;There have been a number of studies investigating factors such as access to healthcare, physician biases, and socioeconomic status that may lead to underrepresentation of Black patients,&rdquo; said Serena Tharakan, BS, of the Icahn School of Medicine at Mount Sinai in New York City, <a href="https://www.eurekalert.org/pub_releases/2021-03/w-goc030321.php">in a press release</a>. &ldquo;However, to our knowledge, our findings are the first to quantitatively demonstrate that the globalization of cancer clinical trials may also be a key driver of racial disparities in the U.S. drug approval process.&rdquo;The study evaluated 35 cancer drugs (49 global <a href="https://www.docwirenews.com/docwire-pick/hem-onc-picks/oncology-clinical-trials-decreased-during-covid-19-pandemic/">clinical trials</a>) that received U.S. Food and Drug Administration (FDA) approval between 2015 and 2018, with each approval receiving a disparity score to compare Black enrollment in clinical trials versus the estimated burden of disease in Black patients.Overall, Black patients consisted of 2.5% of enrollment across the 49 global clinical trials (range, 0-10%). The median disparity score was 0.19 (range, 0.01-0.98). In 21 clinical trials (for 18 FDA drug approvals), 64% of patients were enrolled outside the United States (Range, 0-100%). Black patients made up 3.2% of enrollment (range, 0.2-10%); the median disparity sore was 0.23 (range, 0.01-0.98). The proportion of trial patients enrolled internationally was inversely associated with disparity score (Pearson correlation, &ndash;0.61;&nbsp;P=0.007).The study was published in <a href="https://acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.33463">Cancer</a>.&ldquo;The globalization of cancer clinical trials is associated with a widening racial enrollment disparity gap in the United States. The impact of global trials on domestic clinical trial generalizability warrants further consideration from a regulatory and policy standpoint,&rdquo; the researchers wrote in their conclusion.Recently, researchers from the Dana-Farber Cancer Institute, FDA, and American Association for Cancer Research <a href="https://www.docwirenews.com/docwire-pick/new-recommendations-to-improve-racial-disparities-in-mm-drug-trials/">issued new guidelines</a> aimed at increasing Black representation in clinical trials for multiple myeloma. Black patients are disproportionately at a greater risk for multiple myeloma but are largely underrepresented in clinical trials.Among the suggestions are broadening eligibility criteria whenever possible, requiring trial sponsors to complete diversity study plans to set enrollment targets, appointing a diversity officer to aid with trial design and recruitment, and continuing to gather data on racial and ethnic differences in treatment safety and efficacy during the post-approval period.&ldquo;The number of African Americans enrolled in clinical trials of novel agents or treatments of multiple myeloma has been tragically low. When they have enrolled, their outcome to treatment with novel therapies has been the same or even better than other patients,&rdquo; said co-author Kenneth C. Anderson, MD, medical oncologist at Dana-Farber and program director of the Lebow Institute for Myeloma Therapeutics and the Jerome Lipper Multiple Myeloma Center, in a&nbsp;<a href="https://www.eurekalert.org/pub_releases/2021-02/dci-nra021721.php" target="_blank" rel="nofollow noopener noreferrer">press release</a>.

Tamara Thomas

Dr. Cory Rice Explains Life After GLP-1s  - Q & A

Obesity

Urban Health Today Editors

Dr. Erin Dickman on Oncology Nurses' Impact on Breast Cancer Survivorship  and Lymphedema Management

Workforce News

Lou Portero

Important New Research Findings in Familial Risk of Postpartum Psychosis

Women's Neurology

Latest News

Globalization of Cancer Clinical Trials Widened Racial Disparity Gap for Black Enrollees

Cancer

The globalization of cancer clinical trials resulted in fewer Black patients being enrolled, further widening the racial gap in cancer clinical trials.

Clinical Trials Globalization Widened Racial Disparity Gap in Cancer Trials

About Us

Editorial Policy

Contributors & Partners

Contact Us

eNewsletters

Work With Us

Advertising

Career Center

GU Oncology Now

Blood Cancers Today

Cancer Nursing Today

DocWire News

MashupMD

Food Allergy Roundtable Discussions

Allergy

Blood Cancers

— Multiple Myeloma

Breast Cancer

Colorectal Cancer

Pancreatic Cancer

Prostate Cancer

Diabetes

Gastroenterology

Heart Failure

Heart Disease Prevention

Heart Health

— Alzheimer’s Disease

Neurology

Public Health

Autoimmune Disease

Infectious Diseases

Pediatrics

Sickle Cell Disease

Digital Health

Dermatology

Pulmonology

Video Insights

More

Gynecologic Cancer

Heart Disease in Women

Menopause

Reproductive Health

Women’s Neurology

Well Woman Today

Roundtables

Podcasts

Conferences

Viewpoints

Subscribe