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Data-driven diversity: Making clinical trials equitable for all

Image courtesy of Pixabay

Lack of diversity in clinical trials has long been an issue, driven by challenges with recruitment and participation. In recent years, pharmaceutical companies have prioritized recruiting more diverse patient groups for their trials. And in some areas, it is working. In the past ten years, the representation of Black and African American patients in U.S.-based clinical trials has improved. Currently, data from Phesi show that 14.9% of clinical trial participants self-identify as being in this group. That proportion is slightly greater than the 13.4% of the U.S. population that identifies as Black and African American, according to the 2019 U.S. Census.

To develop truly effective therapies for all, clinical trials must be carried out in populations representative of those who will receive the new treatments. However, certain patient subpopulations are significantly and consistently u…

Abbott pledges funding to increase clinical trial diversity

A researcher at the Morehouse School of Medicine [Photo courtesy of Morehouse School of Medicine]Abbott Laboratories (NYSE:ABT) today announced $5 million in scholarships to promote diversity in the next generation of clinical trial leaders as part of an initiative to improve healthcare for all.

The Abbott Park, Illinois-based developer and manufacturer of medical devices and drugs said its initiative also includes forming the Diversity in Research Medical Advisory Board, funding improved access for women and under-represented communities in Abbott trials, and convening patient advocates, industry experts, trialists and physicians to develop and share ways to increase clinical trial diversity.

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Abbott pledges funding to increase clinical trial diversity

A researcher at the Morehouse School of Medicine [Photo courtesy of Morehouse School of Medicine]

Abbott Laboratories (NYSE:ABT) today announced $5 million in scholarships to promote diversity in the next generation of clinical trial leaders as part of an initiative to improve health care for all.

The Abbott Park, Illinois-based developer and manufacturer of medical devices and drugs said its initiative also includes forming the Diversity in Research Medical Advisory Board, funding improved access for women and under-represented communities in Abbott trials, and convening patient advocates, industry experts, trialists and physicians to develop and share ways to increase clinical trial diversity.

The FDA has encouraged more gender and ethnic/cultural diversity in clinical trials to improve the safety and efficacy of medical products for all who will use them, but factors like trust, site access and commun…

How Lilly Oncology is aiming to improve clinical trial diversity

Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. For instance, the mortality rate for Black women with breast cancer is 40% higher than that of white women.

The pandemic, however, has highlighted persistent health disparities while offering potential strategies for improvement, according to Amy Davis, senior director of clinical development at Lilly Oncology.

The pandemic has popularized the use of decentralized trials. For instance, Lilly debuted decentralized capabilities in a recent breast cancer trial and will continue doing so for upcoming trials. “We are building in decentralized capabilities from the get-go — decreasing the number of in-person visits by half,” Davis said. The company is using remote data capture and offer…

7 ways to ensure your medical device product design isn’t biased

Correcting unintentional biases in medical device product design is a big step toward improving equity in medtech.

[Image from Pixabay]

Achuta Kadambi, an assistant professor at the UCLA Samueli School of Engineering, says when looking at bias in medical devices, there’s often a lot of narrative in the media of what it is. However, it’s also important to address what it doesn’t show.

“One that doesn’t show up is that it’s a really challenging technical problem and an exciting technical problem to address,” he said, citing an example of how light doesn’t play well with darker objects like darker skin tones.

Kadambi, who recently published a column in the journal Science about achieving fairness in medical devices, says there has to be a technical passion for solving these problems. (He also discussed his views during a recent DeviceTalks Weekly podca…