diversity Archives - Medical Design Sourcing

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…

Medtronic reports diversity gains and a larger manufacturing footprint

A year-over-year comparison of Medtronic’s latest annual report shows an increase in gender and racial diversity, a larger manufacturing and research footprint and some big moves in its manufacturing locations ranking.

A Medtronic employee checks inventory in Galway, Ireland, where the device maker has significant manufacturing operations. [Photo courtesy of Medtronic]

Medtronic reported gains for women and ethnic diversity in its workforce at the end of its fiscal year, which ended in April 2023

The world’s largest medical device company said in its newly released annual report that women now make up 51% of its global workforce, up from 50% at the end of fiscal 2022.

Diversity in medtech: 2022 markedly the best for women in medtech

Ethnic diversity among Medtronic’s U.S. workers climbed to 40% from 38% a year ago, including 28% of U.S. managers. Medtronic als…

Abbott expands initiative to increase diversity in clinical trials

Abbott (NYSE:ABT) announced a new series of programs within its multi-million-dollar initiative to increase diversity in clinical trials and improve care in under-represented populations.

The additions to Abbott’s “Diversity in Clinical Trials” initiative build on partnerships, scholarships and the focus on diversified patients. Abbott applied these to its own clinical trials throughout the initiative’s first year. Within that first year, the company established a Diversity in Clinical Trials Medical Advisory Board. Through $5 million in grants, it also sponsored more than 300 scholarships at four historically black colleges and university (HBCU) medical schools, plus the National Black Nurses Association and National Association of Hispanic Nurses.

Within this program expansion, Abbott launched a new initiative with the Norton Healthcare Foundation. It aims to build and implement new models of sustainable clinical research alongside the…

Breaking down barriers: Prioritizing diversity in clinical trials

[Image courtesy of FDA]

Diversity in clinical trials is crucial for ensuring that new medical treatments are safe and effective for all populations. Last year, the FDA released draft guidance that aims to improve the enrollment of historically underrepresented populations in clinical trials.

Demand is growing for more transparency and diversity in clinical trials, according to Erin Leckrone, senior director of clinical trials at Be The Match BioTherapies. Additionally, a growing number of stakeholders are stepping forward to promote diversity. “The COVID pandemic really amplified a lot of people’s voices in this space,” she said.

A growing number of stakeholders have stepped forward to demand better diversity in clinical trials and to understand “what data is actually collected as part of the clinical trials,” Leckron said. Those players range from regulatory agencies like the FDA to clinical trial …

Janssen sees Blood Cancer Awareness Month as an opportunity to close the clinical trial diversity gap

Janssen (NYSE:JNJ) is working to highlight the importance of cancers such as leukemias, lymphomas and multiple myeloma for Blood Cancer Awareness Month in September.

Some 1.5 million people in the U.S. are currently living with or in remission from blood cancers, according to the Leukemia & Lymphoma Society. Roughly 35,000 people are diagnosed with multiple myeloma each year, according to the American Cancer Society.

In addition to highlighting the incidence of hematologic malignancies, Blood Cancer Awareness Month offers an opportunity to provide education about the need for improved clinical trial diversity. While the industry has made strides recently, people of color continue to be underrepresented in clinical trials. According to FDA data, in 2020, three-quarters of trial participants were white, while only 8% were Black. That same year, 11% of clinical trial participants were Hispanic.

According to the U.S. Census Bureau, 13.6% of the U.S. popu…

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.

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.

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…

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…

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…

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…

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.