Engaging community physicians (provider-engagement models like MedVector's) widens access to larger, more diverse patient populations, while Latin America's large, treatment-naïve populations help sponsors meet FDA Diversity Action Plan expectations — and recruit faster.
From the Global Trial Accelerators™ podcast with Scott Stout (MedVector): watch the episode.
The FDA increasingly expects trial populations to reflect the diversity of the intended-use population under its Diversity Action Plan guidance. Diverse enrollment improves the generalizability and safety evidence of a device or drug. Latin America's large, varied populations can strengthen a sponsor's diversity profile.
Latin American sites often have large, centralized, treatment-naïve patient populations and high per-site volumes, which shortens the time to enroll a first-in-human or early-feasibility cohort compared with fragmented US recruitment.
It's an approach that engages community healthcare providers to offer trials as a care option to their patients — without requiring those physicians to become investigators — unlocking access to larger, more diverse patient pools than traditional site-based recruitment.