To Reduce the Huge Costs of Randomized Clinical Trials, Groups Are Excluded for Whom the Trials Matter Most

(p. D5) Geriatricians have complained for years that figuring out treatments for their patients becomes dramatically more difficult when older people are excluded from clinical trials and other research.

For an 83-year-old, what are the risks and benefits of a surgical procedure, drug or medical device tested primarily on those in their 50s? When a drug trial excludes those who have several diseases and take other drugs, how do the results pertain to older adults — most of whom have several diseases and take other drugs?

. . .

Critics of age exclusion had reason to celebrate in December, when the National Institutes of Health issued new policy guidelines for the research it funds.

Starting next January, grant applicants will have to explain how they intend to include people of all ages, providing acceptable justifications for any group they leave out. The agency will monitor investigators to make sure they comply.

“It’s the right starting point,” said Dr. Florence Bourgeois, a pediatrician at Harvard Medical School. (Children also wind up taking drugs tested only in adults.)

. . .

How often are old people left out of important medical research? In 2011, it looked like progress when Dr. Donna Zulman and her colleagues at the University of Michigan reviewed 109 clinical trials published in leading journals and found that just 20 percent set upper age limits for participation.

An earlier review of trials published from 1994 to 2006 had found that 39 percent shut out people over age 65.

But, as the University of Michigan team also pointed out, even without age limits, studies may bar participants who have multiple disorders or disabilities, or those with limited life expectancy or cognitive impairment. Some researchers won’t enroll nursing home residents.

Those restrictions, too, effectively push older people out of clinical trials and other studies.

Maddeningly, exclusion rates remain high even for studies of diseases particularly common at older ages. Dr. Bourgeois and her colleagues looked at clinical trials for heart disease medications, for instance — primarily blood thinners, cholesterol and blood pressure drugs.

More than half of the trials had upper age limits, usually 75 or 80, and only about 12 percent of participants were aged 75 or older. Yet nearly 40 percent of people hospitalized with heart attacks are over age 75.

For the full story see:

Paula Span. “The Clinical Trial Is Open. Older People Need Not Apply.” The New York Times (Tuesday, April 17, 2018 [sic]): D5.

(Note: ellipses added.)

(Note: the online version of the story has the date April 13, 2018 [sic], and has the title “The Clinical Trial Is Open. The Elderly Need Not Apply.”)

Some published academic articles supporting the points made in the passages quoted above are:

Bourgeois, Florence T., Liat Orenstein, Sarita Ballakur, Kenneth D. Mandl, and John P. A. Ioannidis. “Exclusion of Elderly People from Randomized Clinical Trials of Drugs for Ischemic Heart Disease.” Journal of the American Geriatrics Society 65, no. 11 (Nov. 2017): 2354-61.

Bourgeois, Florence T., Srinivas Murthy, Catia Pinto, Karen L. Olson, John P.A. Ioannidis, and Kenneth D. Mandl. “Pediatric Versus Adult Drug Trials for Conditions with High Pediatric Disease Burden.” Pediatrics 130, no. 2 (Aug. 2012): 285-92.

Cruz-Jentoft, Alfonso J., Marina Carpena-Ruiz, Beatriz Montero-Errasquín, Carmen Sánchez-Castellano, and Elisabet Sánchez-García. “Exclusion of Older Adults from Ongoing Clinical Trials About Type 2 Diabetes Mellitus.” Journal of the American Geriatrics Society 61, no. 5 (May 2013): 734-38.

Lewis, Joy H., Meredith L. Kilgore, Dana P. Goldman, Edward L. Trimble, Richard Kaplan, Michael J. Montello, Michael G. Housman, and José J. Escarce. “Participation of Patients 65 Years of Age or Older in Cancer Clinical Trials.” Journal of Clinical Oncology 21, no. 7 (April 2003): 1383-89.

McGarvey, Caoimhe, Tara Coughlan, and Desmond O’Neill. “Ageism in Studies on the Management of Osteoporosis.” Journal of the American Geriatrics Society 65, no. 7 (July 2017): 1566-68.

Zulman, Donna M., Jeremy B. Sussman, Xisui Chen, Christine T. Cigolle, Caroline S. Blaum, and Rodney A. Hayward. “Examining the Evidence: A Systematic Review of the Inclusion and Analysis of Older Adults in Randomized Controlled Trials.” Journal of General Internal Medicine 26, no. 7 (July 2011): 783-90.

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