| | | | |  | | By Ben Leonard, Carmen Paun, Ruth Reader and Erin Schumaker | | | | |  Recruiting diverse clinical trial participants is an ongoing challenge for drugmakers. | Getty Images | A lack of diversity in clinical trials threatens the development of effective drugs and medical devices. That's because not all populations have the same responses to treatments and devices, and trials that don't include them all could miss problems. The nonprofit organization Bioethics International took a deep dive into cancer trials and found that many didn't "adequately" represent older adults, women and some racial groups, a new study in BMJ Medicine found. Researchers from Yale and Stanford noted that even though a number of policy efforts have addressed the issue — including FDA guidance, the 21st Century Cures Act and voluntary efforts from the biopharmaceutical industry — they haven't made enough of an impact. "There have been over 40 years of policy efforts to diversify clinical trial participants," said Jennifer Miller, an associate professor of medicine at Yale, Bioethics International founder and an author of the study. "They haven't sufficiently measurably improved equity." Miller and her colleagues examined 64 trials from 25 companies between 2012 and 2017 and found: — 76 percent didn't adequately represent older people. — 84 percent didn't adequately represent racial and ethnic groups. — 44 percent didn't adequately represent women. — 24 percent of companies were transparent in reporting race and ethnicity data. The researchers also crafted a scorecard from zero to 100 percent on "fair inclusion" for the 25 companies. Eight companies scored in the top quarter, earning a "gold" rating, and five earned a "silver" rating, placing them at or above the median score of 81 percent.
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| Ben reached out to the companies, and they broadly supported efforts to bolster diversity in clinical trials. Pharma companies respond: — "This study reinforces the need for rigorous and strategic programs designed to address the barriers to the enrollment of people from underrepresented groups," said Adrelia Allen, Merck's senior director of clinical trial diversity. — Diversity should be a priority, an Exelixis spokesperson said, while pushing back on the study design. "The narrow study methodology, which focuses only on a drug's initial approval, means that in Exelixis' case, the authors considered just one pivotal trial — our first — that began in 2008," the spokesperson said, adding that in the years since, the company has done nine trials and shown a commitment to representation. — "We are deeply committed to addressing barriers to clinical trial participation," a spokesperson for Roche said. — "We set a clear ambition in 2022 to ensure over 75 percent of our interventional clinical trials have a clear demographic plan aligned with disease epidemiology," a GSK spokesperson said, adding that the firm is "committed" to transparent reporting of results.
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South Road, Winchester, Conn. | Shawn Zeller | This is where we explore the ideas and innovators shaping health care. According to new data from the Centers for Medicare and Medicaid Services, accountable care organizations, which offer value-based care to Medicare patients, are back on a modest rise after a multi-year decline. Numbers were up in both 2021 and 2022. Ruth wants to know what you think? Are changes at CMS incentivizing doctors to create accountable care organizations? Share any other thoughts, news, tips and feedback with Ben Leonard at bleonard@politico.com, Ruth Reader at rreader@politico.com, Carmen Paun at cpaun@politico.com or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. Today on our Pulse Check podcast, Krista Mahr talks with Megan Messerly about the Biden administration's plans to expand the testing of bathroom wastewater from international flights to detect Covid variants and other pathogens — a practice that administration officials and public health experts see as part of a revolution in biosafety infrastructure and a critical plank of national security in the post-pandemic era.
| | | | | | |  A new report says medical personnel feel underpaid and overworked. | Getty Images | Morale is low among health care workers, who are dissatisfied with their compensation, their work environment and their leaders, a new study from software firm Qualtrics found. Some key points: — Forty-eight percent of employees in the sector feel they're not being paid fairly, the lowest level in any industry studied. — Fewer than 2 in 5 believe their pay is "clearly linked to their performance." — Health care workers rate their employers' work processes lower than average when compared with other sectors. — Employees in the sector said they were less engaged, their job experience didn't live up to their expectations and they were thinking about leaving more than those in other sectors. The report adds to the mounting evidence of burnout among health care workers, which rose during the pandemic amid strain on the system from Covid-19 patients and the emotional toll that came with it. "Health care has an advantage in that much of its history is anchored in 'patient centered' care and leaders must pivot to a 'person centered' strategy that recognizes quality, safety, and experience all depend on a healthy, thriving workforce," said Adrienne Boissy, chief medical officer at Qualtrics. "Earning the trust of the workforce depends on our ability to keep promises to our patients and people." The report suggested: — Modernizing technology to ease the burden on providers with automation — Engaging with employees to better gauge what makes them "feel valued" The study also looked at patient satisfaction, finding that: — Sixty-one percent of patients believe providers need to listen more to their feedback. — Sixty-nine percent of patients felt the same way about insurers. The report suggested that health care organizations could learn from other industries by personalizing services to make customers feel valued.
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| ABORTION PILL ACCESS: On a new episode of The POLITICO Show by Jackie Padilla and Meiying Wu, Jackie explains where the FDA's decision to allow retail pharmacies to dispense the abortion pill will expand access to it, as well as where it won't.
| | | | LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today. | | | | | | | | |  New technology could relieve people with diabetes of the need to measure their own blood glucose levels. | AP | A technology described as a step toward an artificial pancreas is set to be recommended to some people with type 1 diabetes in England. The technology allows people with diabetes to go about their daily lives without worrying their blood glucose levels are too high or too low, the U.K.'s National Institute for Health and Care Excellence said. NICE is an independent body that assesses new treatments in England and Wales. Type 1 diabetes causes a person's blood glucose levels to become too high because their pancreas produces little or no insulin. This can lead to blindness, amputations or kidney disease. The technology, called a hybrid closed-loop system, is made of a continuous glucose monitor sensor attached to the body that transmits data to a body-worn insulin pump. The latter calculates how much insulin the body needs to keep glucose levels within a healthy range. NICE recommended the technology for more than 100,000 people with type 1 diabetes who have been unable to control their glucose levels using standard methods and are at risk of long-term complications. This recommendation is open for feedback until Jan. 31. There's one problem, though: The price. The average annual cost for the new technology is around $7,000, which NICE considers too expensive to be cost-effective for the National Health Service. NICE and NHS England will negotiate with the producer to try to lower the price. | | | | Follow us on Twitter | | | | Follow us | | | | |
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