Launching a new drug represents the culmination of years of work, from research and discovery to clinical development and product launch. We are working to understand and address the systemic barriers to clinical study participation faced by historically underrepresented patient groups. “We have to meet patients where they are,” says Genentech Vice President and Chief Diversity Officer Quita Highsmith. “That means going to the patient and partnering with community health institutions that our patients know and trust. That also means that as an industry we need to stop blaming underrepresented patients, and recognize patients who have been historically marginalized and don’t have access to medical benefits might face additional barriers such as high co-pays and transportation challenges.”
Inclusive research should be proactive. City of Hope is focused on building sustained trust with communities through a consistent presence. Where we can, we are being more creative in alleviating financial burdens and helping patients navigate access to study participation.
- Rick Kittles, Ph.D., Professor And Founding Director, Division of Health Equities, Department of Population Sciences, Associate Director for Cancer Health Equities, City of Hope
The Genentech Research and Early Development (gRED) team, which focuses on the early phase of the drug development process, has several studies underway that actively seek to increase participation by historically underrepresented patient groups. One such study, a Phase II study involving Astegolimab, is focused on a treatment for Chronic Obstructive Pulmonary Disease (COPD). To ensure the study reflects the real-world population, the gRED study team has developed a plan to enroll diverse patients by using U.S. Census data to concentrate the clinical sites in the southern states in the U.S. and other diverse areas, thereby providing access to historically underrepresented communities and patients of low socioeconomic status.
Including underrepresented patients in clinical studies is critical to developing medicines for all patients. But it's not enough to simply include these diverse communities; teams also need to address the challenges that keep patients from participating. For instance, the Phase II Astegolimab COPD study plans to employ interventions to remove barriers, including simplifying the study protocol to reduce the burden of frequent in-clinic visits and offering transportation to make it easier for participants to travel to and from the research sites. The availability of mobile nursing should also enable participation from patients whose jobs or transportation issues would prevent them from being able to travel.
We’ve expanded inclusive research strategies from individual studies to the program level, which gives us the insights and momentum to launch entire portfolios of therapies across all phases of the drug development lifecycle.
- Teresa Graham, Head of Global Product Strategy, Roche
In Inclusive Clinical Studies, the Details Matter
Throughout the clinical study process, Genentech researchers advance representation among historically underrepresented patient groups through protocol design such as:
- Using population demographic data from sources such as the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey to identify the disease population in the U.S., which can help set benchmarks for participant diversity among different patient groups.
- Partnering with patient advocacy groups to provide feedback to design more inclusive studies. One study for a multiple myeloma drug created a visit simulation between the site coordinator and the patient. The goal was to help the team understand and address the specific challenges patients might face, from the amount of time required for participation to the potential financial burdens shouldered by some participants. The result was a recommendation by the participants to reduce the number of procedures and visits, and it provided a better understanding of the barriers faced by the patients.
- Incorporating feedback from patient interviews to tailor support strategies for the unique needs of participants in global studies. These support strategies may include compensation for time and reimbursement of travel and child care costs, and guidance on nutrition and mindfulness.