A Nation’s Cry & A Moment for Greater Diversity in Clinical Trials

Since 2020 began, the U.S. Food & Drug Administration (FDA) has approved at least twenty new drugs for use by American consumers, but over 90% of those drugs were tested on a subject population that lacked sufficient race and ethnic diversity to determine if the drug would be safe and effective for everyone. 

With a growing surge in people of all backgrounds demanding for racial equality and justice for all, primarily driven by widespread national headlines and videos depicting stories of Black people being killed by police, the racial disparity in subjects represented in clinical trials poses no longer the question of why is this happening, but when will it stop?

Back in 2014, there was an industry-supported education campaign to push for greater diversity. It was called “I’m In” and it came just as quickly as it left, leaving a trail of clinical trials that remained largely lacking in diversity.

According to the FDA.gov Drug Trials Snapshot page, the 20 new medications approved since January represent drugs that have never been sold or marketed in the U.S. before.

The drugs were approved to treat a range of illnesses and conditions, such as: 

  • Gastrointestinal tumors 
  • Breast cancer 
  • Cushing’s disease
  • Malaria
  • Post-operative nausea and vomiting

These conditions impact individuals of every race and ethnic background.

For decades, research has cited that race and ethnicity are relevant indicators for how safe and effective a medication can be for an individual of a certain background. 

However, the vast majority of the 20 new drugs approved in 2020 and reflected in the Drug Trials Snapshots, stated that the “majority of patients were White, therefore race differences could not be determined.” Only 1 of the 20 drugs was identified as working “similarly across racial groups”.

One drug lacking sufficient diversity, Tukysa (tucatinib), was approved to treat metastatic breast cancer. It was tested on 436 White patients, but only in 53 patients who were Black, 23 listed as Asian, and 5 identified as “Other”. 

The lifetime risk of developing breast cancer is nearly the same for White, Black and Asian women (at 13%, 12%, and 11% respectively and according to research data) and, according to the CDC, Black women have been more likely to die from breast cancer. 

On the FDA’s website, it states that Drug Trials Snaphshots “provide consumers and healthcare professionals with concise information about who participated in clinical trials that supported the FDA approval of new drugs” and “are part of an overall FDA effort to make demographic data more available and transparent”.

To review the full list of medications that were approved this year, per the Drug Trials Snaphots, visit https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots.

To help Safest Drug fight for more equitable representation in clinical trial subjects, visit here

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