Moving the needle on diversity in clinical trials: Where do we go from here?

[Image courtesy of Adobe Stock]

Enhancing patient diversity in clinical trials has become a key priority in drug development. The main concern is that critical data that includes underrepresented patient populations is being left out as many clinical trials do not reflect all populations that may eventually take a therapy. These underrepresented groups consist of women, including those who are pregnant and lactating, pediatric and elderly patients, people with disabilities, LGBTQ+ individuals, and racial/ethnic groups specifically, Black/African American, American Indian/Alaska Natives, Hispanics/Latinos, Asians, Native Hawaiian, and other Pacific Islanders.

As a result, the U.S. government has taken increased measures with the passage of the Food and Drug Omnibus Report Act of 2022 (FDORA), which will require sponsors to submit diversity plans to the U.S. Food and Drug Administration (FDA) for all late-stage st…

Read more
  • 0

Unraveling the impact of FDORA and PREVENT Pandemics Acts on the life sciences

[freshidea/Adobe Stock]

As the world continues to grapple with global health challenges, the role of science and biotech law has taken center stage in shaping public health policy and innovation. The FDORA and PREVENT Pandemics Acts are poised to help shape the landscape.

In a recent interview, life sciences attorney Barbara Binzak Blumenfeld offers insights into significant recent legislative, judicial, and regulatory developments, including the planned end to the COVID-19 Public Health Emergency (PHE), the enactment of the Food and Drug Omnibus Reform Act (FDORA), and the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).

With a Ph.D. in molecular biology, Blumenfeld is well-versed in the scientific, ethical, and legal issues that are pivotal in the life sciences. In a recent interview, she touched on the expiration of the COVID-19 Public Health…

Read more
  • 0