How the pandemic and George Floyd made clinical trial diversity a priority

[Image courtesy of Chad Davis via Flickr]

Where would clinical trial diversity be without the COVID-19 pandemic and the death of George Floyd on May 25, 2020? It likely wouldn’t be the priority it is today across the industry, according to Ariel Katz, CEO and co-founder of H1, a New York–based healthcare and data analytics platform firm.

After the death of George Floyd, scores of pharma companies created or beefed up departments related to diversity and inclusion. “Basically, every pharma company and biotech is now doing something around diversity and inclusion and social determinants of health,” Katz said.

On Google, interest in the search phrase ‘clinical trial diversity’ surged from July 2020 to July 2021. Interest in the phrase continues to remain strong but has dipped from its peak.

Things have changed considerably during the pandemic.

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Johnson & Johnson shareholders approve racial justice audit proposal

Johnson & Johnson (NYSE: JNJ) investors voted in support of a proposal for a third-party racial justice audit at the annual shareholder meeting.

It was the only shareholder proposal to pass at yesterday’s annual meeting, where investors also considered proposals to discontinue global sales of baby powder containing talc, to study the public health costs of protecting COVID-19 vaccine technology, and to include legal and compliance costs in executive pay metrics.

The vote is only advisory, so it doesn’t require Johnson & Johnson to take action, but it sends a strong signal from investors that they view racial justice as a business matter.

Get the full story at our sister site, Medical Design & Outsourcing.

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Johnson & Johnson shareholders approve racial justice audit proposal

Johnson & Johnson (NYSE: JNJ) investors voted in support of a proposal for a third-party racial justice audit at the annual shareholder meeting.

It was the only shareholder proposal to pass at yesterday’s annual meeting, where investors also considered proposals to discontinue global sales of baby powder containing talc, to study the public health costs of protecting COVID-19 vaccine technology, and to include legal and compliance costs in executive pay metrics.

The vote is only advisory, so it doesn’t require Johnson & Johnson to take action, but it sends a strong signal from investors that they view racial justice as a business matter.

A similar proposal in 2021 had significant support. Johnson & Johnson opposed the proposals both years, saying the company already makes diversity, equity and inclusion (DEI) part of its credo and core values.

Corporate Secretary Matthew Orlando announced the proposal’s passage at the close…

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A real-world data approach for bridging diversity disparities in clinical trials

[Image courtesy of Pixabay]

The lack of appropriate representation in clinical trials, particularly in terms of ethnicity and race, has been a long-standing issue that directly impacts health equity and treatment efficacy. In a 2020 analysis of the global participation in clinical trials, the Food and Drug Administration (FDA) highlighted the vast difference between enrolled participants and the global population. Of the more than 297,000 participants in clinical trials globally, 76% were white, 11% were Asian, and only 7% were Black. By comparison, 60% of the global population hails from Asia, 16% from Africa, 10% from Europe, 8% from Latin America, and just over 4% from the United States.1

The FDA has focused on addressing this issue, drafting new guidance in April 2022 aimed at increasing clinical trial enrollment from underrepresented racial and ethnic populations. This draft guidance, “Diversity Plans to Im…

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MDO wins honors from American Society of Business Publication Editors

Judges reviewed the March and May 2021 editions of Medical Design & Outsourcing before awarding the publication with a design award. [Cover designs by Matt Claney/MDO]

Medical Design & Outsourcing received awards for design and content at the American Society of Business Publication Editors’ 2022 Azbee Awards of Excellence yesterday.

The annual awards program honors outstanding work by U.S.-based business-to-business, trade, association and professional publications, including magazines, websites, email newsletters, social media and blogs. The organization calls its awards program “one of the most competitive” in publishing.

Art Director Matt Claney won a regional silver award for magazine design and was a national finalist. Judges considered the March 2021 and May 2021 editions of MDO.

“MDO showcases the ability to cover everything from hot topics such as post-COVI…

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Johnson & Johnson faces another ballot battle on racial equity audit

Johnson & Johnson is fighting another shareholder proposal for an independent racial equality audit of the company.

New Brunswick, New Jersey–based J&J (NYSE:JNJ) defeated a similar measure at last year’s annual meeting of shareholders, though the vote was far from a landslide. The company also unsuccessfully petitioned the U.S. Securities and Exchange Commission to keep it off the ballot.

Now, an independent audit is again up for consideration at the April 28 annual meeting after surviving another J&J appeal to the SEC.

Proponents of the audit cite ongoing controversies over talcum powder allegedly marketed to minorities. They also point to the J&J Political Action Committee’s financial support of Republican members of Congress who voted to overturn President Joe Biden’s election after insurrectionists stormed the U.S. Capitol.

“Perhaps not since the civil rights era of the 1960s have citizens spoken with a…

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Laying the groundwork for clinical trial diversity 

Image courtesy of Pixabay

The COVID-19 pandemic has elevated the importance of clinical trial diversity while also asserting remote clinical trials as a valid approach for a growing number of drug studies, as a recent JAMA study concluded.

At the same time, the pandemic highlighted the need for continued progress, according to Otis Johnson, chief diversity, inclusion and sustainability officer at Clario.

“I think COVID shone too much of a bright light on the lack of diversity in clinical trials for us not to make progress,” Johnson said.

More regulatory clarity

While a growing number of drug developers are prioritizing diversity, “regulatory agencies will need to be more deliberate,” Johnson added. “So far, the guidance has been exactly that — guidance.” Regulatory agencies should mandate best practices supporting diversity in clinical trials, he said.

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Data-driven diversity: Making clinical trials equitable for all

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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…

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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 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.

Get the full story at our sister site, Medical Design & Outsourcing.

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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…

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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…

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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…

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