Table 1 Roche/Genentech recruitment strategies to improve diversity of ophthalmology clinical trials.
Strategy | Examples |
|---|---|
Site feasibility and targeted selection | |
• Select investigators at sites with access to diverse populations • Select investigators from under-represented communities | • Expanded site selection to other regions across the United States, including Puerto Rico and Hawaii (PAGODA, Pavilion trials) |
Investigator engagement | |
• Improving awareness of disparities and clinical trial availability | • Presentations at investigator meetings about commitment to diversity and request support for this effort |
Protocol content | |
• Diversity plan for each molecule that outlines strategies • Update of inclusion/exclusion criteria • Focus on patient-centred outcomes | • Updated HbA1c criteria to 12% (Pavilion trial), contrary to historic regulatory guidance |
Patient support and engagement | |
• Inclusive patient materials • Partner and sustain engagement with community stakeholders and patient advocacy groups • In the diabetic eye disease space, support patients with broad diabetes care | • Curated educational resources to encourage diverse populations to participate in the trial (PAGODA, Pavilion trials) • Informed consent forms and study materials in Spanish (and other languages as requested by sites) |
Vendor selection | |
• Utilisation of innovative recruitment vendors to screen for potential patients and refer them to sites | • Partner with primary care facilities located in communities with reduced access to specialised eye care and provided them with diagnostic systems to identify patients for referral to nearest clinical site (PAGODA, Pavilion trials) |
Trial accessibility | |
• Covering out-of-pocket patient costs | • Transportation costs |
