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Transparency has improved but more work is needed to achieve diversity in clinical trials. Plus, a podcast gives some good news about biotech and plastic. (631 words, 3 minutes, 9 seconds) |
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More work needed to ensure clinical trial diversity, report says |
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The 50-year-old effort to ensure diversity of the populations involved in clinical trials had some impact but more needs to be done, according to a study published this month by IQVIA.
The report finds: “Disparities in outcomes across different patient groups”—based on race, gender, age, and other factors—persist throughout health care, including in recruitment for clinical trials.
Why it matters: A clinical trial that is not adequately diverse “risks failing to identify potential differences in therapy efficacy or safety in populations,” and exacerbates health inequity, the report says.
One improvement has been the amount of attention paid to clinical trial diversity. The report notes “a dramatic increase in reporting of diversity data has occurred over the past five years.” There has also been “a marked increase” in the attention and efforts dedicated to the issue by multiple stakeholders.
But we’re not there yet. “Based on race/ethnicity data reported, both Black/African American and Hispanic participation in trials fall short of 2020 U.S. demographics levels of 13.6% and 18.9% respectively,” the report says. In trials with U.S.-only sites, Black/African American participation reached 18% in 2013, but dropped to 14.3% in 2020 “before falling dramatically to just 9%” in 2021, the report says.
Improving clinical trial diversity requires efforts from all stakeholders, the report says. It identifies positive steps taken by regulators, payers, sponsors, patients—and clinical trial managers, partners, and sites. BIO actively promotes clinical trial diversity and has recommended improvements to the FDA. We also covered the topic on the I am BIO podcast.
We must continue progress, building on transparency achieved through better reporting, the report says: “One of the clearest opportunities to improve diversity in clinical development is through better trial and program diversity tracking, analysis, and reporting with aligned and objective metrics.”
Download the full report. |
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I am BIO Podcast: Microbes, bioplastic…and art? |
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Plastics are choking the planet—but they’re a hard habit to break. As with many of our biggest challenges, we can look to biotech—and art—for solutions, says the new episode of the I am BIO Podcast.
One solution: “replacing fossil-based, non-biodegradable plastic with plant-based options is one part of the solution,” says podcast host and producer Theresa Brady.
There’s biodegradable plastic—like Danimer Scientific’s polyhydroxyalkanoate (PHA) biopolymer, made by fermenting bacteria. Microbes eat PMA—and it’s gone within 6 months, says Danimer’s Chief Marketing Officer Scott Tuten.
And there’s plastic made from renewables—like the kind from Virent, which uses sugar cane, sugar beets, and corn to make a plastic alternative with reduced carbon intensity and emissions, says Virent VP Andrew Held. (Coca-Cola has taken notice.)
Bacteria can “eat” traditional plastic—rarely and slowly. Washington University scientists are genetically modifying bacteria to break down plastics much more quickly into useful materials, says Dr. Tae Seok Moon, whose lab is also looking into finding ways to make the genetically modified bacteria “self-destruct” when the plastic is gone.
Art can call attention to the problem, says guest Ben Lear, who wrote “Lillian,” a folk opera about the Great Pacific Garbage Patch, a mass of floating ocean debris. The musical serves to “raise awareness and educate the next generation.”
Listen: The podcast is available now on Apple, Google, Spotify, or wherever you get your podcasts. |
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ICYMI: Christophe Schilling, CEO of Geno and a member of BIO’s Ag and Environment Governing Board, testified during the Senate Agriculture, Nutrition, and Forestry Committee Farm Bill hearing yesterday—watch the highlights and read more here. |
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