Bristol Myers launches program to make clinical trials more accessible for people with disabilities
About a fourth of US adults live with some type of disability, according to the CDC. On Wednesday, Bristol Myers Squibb launched a new initiative to ensure those patients get access to clinical trials.
The pharma giant is teaming up with the nonprofit Disability Solutions to create the Disability Diversity in Clinical Trials (DDiCT) Initiative, a program that’s initially focusing on coming up with a set of recommendations for improving access, speed of enrollment and participation of people with disabilities in trials.
“We collect data around other underrepresented groups in clinical trials,” Julie Sowash, executive director of Disability Solutions, told Endpoints News. “People with disabilities are almost always excluded from that demographic collection.”
The news comes as pharma companies face mounting pressure to make clinical trials more inclusive. A slate of pharma companies has set equity goals, including Gilead, which today announced an $85 million contribution to the Gilead Foundation to support health equity.
A recent review of studies in the UK’s National Institute for Health and Care Research portfolio found that 60% excluded learning disability groups — and researchers have noted similar exclusion in the US. According to a JAMA review of Phase III and IV studies, explicit exclusion criteria prevented a significant number of people with intellectual, developmental or physical disabilities from participating in trials.
Other barriers to participation include inaccessible trial sites, medical equipment and “ableist biases which deter this community from receiving potentially life-saving treatments,” BMS said in a statement. Sowash cited informed consent as one specific example of this.
“There are a lot of regulations around can a person with a disability consent, who can consent for them?” she said. “And we need to just see, are those medically necessary? Are they medically relevant to the research process?”
The initiative aligns with BMS’ broader diversity goals, including a commitment to locate a quarter of its clinical trial sites in “highly diverse communities” this year. It was initiated by BMS’ Disability Advancement Workplace Network (DAWN), and will be co-led by the company’s global drug development team.
While Sowash hopes the initiative will eventually help set a new industry standard for clinical trial protocols, she acknowledged that they’re still in the “knowledge-gathering stage,” which involves collecting data, identifying barriers and understanding how to make trials more accessible.
“We’re going to start to see what those gaps and opportunities are to make what could be dramatic improvements to access for healthcare for people with disabilities,” she said.
“Through this work, Bristol Myers Squibb can set the standard and stage for access to life-changing and life-saving medicines for people with disabilities,” BMS CMO Samit Hirawat said in a statement. “The long-term goal of our DDiCT program is to develop and pilot trials that are accessible to the widest variety of patients.”