Drugmaker set to include people with disabilities in clinical trials

With a new initiative, Bristol Myers Squibb is seeking recommendations on how to better integrate people with disabilities into clinical trials. (Bristol Myers Squibb)

People with disabilities are often excluded from clinical trials, which limits what is known about how new treatments will affect people with various conditions. Today, a big pharmaceutical company is looking to change that.

Bristol Myers Squibb says it will work with a non-profit organization called Disability Solutions on recommendations to “effectively improve access, engagement, speed of enrollment and participation of people with disabilities in clinical trials, so to ensure that all patient groups reflect the real-world population and align with the epidemiology of disease studies.

The so-called Disability Diversity in Clinical Trials, or DDiCT, initiative is part of a broader effort by the company — one of the world’s largest pharmaceutical manufacturers — to increase inclusion and diversity.

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“Through this work, Bristol Myers Squibb can set the standard and the stage for access to life-changing and life-saving medicines for people with disabilities,” said Dr. Samit Hirawat, Executive Vice President and Chief Medical Officer for the global drug development at the company. “The long-term goal of our DDiCT program is to develop and pilot trials that are accessible to the widest variety of patients.”

In announcing the initiative, Bristol Myers Squibb officials pointed to a 2018 article in the Journal of the American Medical Association, which found that in 338 phase III and IV studies, 12.4% of people with intellectual disabilities or developmental were excluded due to exclusion criteria. .

“People with disabilities are omitted from conversations about diversity and inclusion, despite being the largest underrepresented group in the world and the only underrepresented group that can be reached at any time. Therefore, it is essential that we expand the scope of medical trials and research,” said Tinamarie Duff, who leads the Disability Advancement Workplace Network at Bristol Myers Squibb.

The issue came to the fore earlier this year when the Centers for Medicare and Medicaid Services proposed a plan to limit access to a controversial new Alzheimer’s drug to those participating in clinical trials. Even though the lifetime risk of developing Alzheimer’s disease is over 90% for people with Down syndrome, the proposal said people with the chromosomal abnormality would be excluded from participation.

Amid pushback from advocates, CMS reversed course and removed the Down syndrome exclusion from the final determination.

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