To fully address the complex issue of patient diversity in clinical trials requires collaboration among the pharmaceutical industry, organizations conducting the trials, patients and patient advocates, community partners, and the US Food and Drug Administration (FDA), said Sabine Luik, MD, senior vice president of Medicine and Regulatory Affairs at Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim has been working to find new approaches, including fair reimbursement for costs, such as for travel and food, which are incurred by patients during clinical trials. Additionally, it is exploring how to use digital technologies and implement home visits to reduce patient burden.
“We are also working closely with patients to gather more input in our clinical development and clinical trial programs to ensure they are accessible and expand the pool of potential patients for clinical trials to attract and retain more minority patients,” Luik told Outsourcing-Pharma.com.
Luik added that the company also trains its site staff and site-facing staff on the importance of diverse populations in trials and in unconscious bias.
“Proactive translation of study documents and providing other innovative tools to sites has also become a standard process to ensure clear and simple communications with patients about what to expect,” she said.
While Luik explained the company has learned “a tremendous amount” through the company’s own initiatives, it has “experienced some difficulties along the way with enrollment and retention.”
Moving forward, Luik said the company will continue to build on these key learnings for current and future trials.
“It has not been easy, but we are actively collaborating with a variety of partners and advocacy groups to help us work through these challenges, and will continue to identify new partners to help us move this important work forward,” she added.
Boehringer Ingelheim recently joined leaders at Northwell Health’s Feinstein Institute for Medical Research, the FDA to discuss the challenges and opportunities to increase patient diversity in clinical trials.
“The pharmaceutical industry cannot overcome social issues, fear and mistrust alone,” added Luik.
“We need to partner with trusted community partners can help address these issues and help us better communicate with patients. Partnering will help us better tailor our approach to patients who have been historically underrepresented in clinical trials.”