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Session 4, Track A: Innovative Trial Designs: Accelerating Access Through Smarter Evidence
Session Chair(s)
Diego Alexander Salas, LLM
Regulatory Affairs Director, Federación Latinoamericana de la Industria Farmacéutica, A.C., Mexico
Marcela Garrot, RPH
Associate Director, Principal Clinical Site Lead LATAM, Merck Group, Argentina
Innovative clinical trial designs are transforming the way we generate evidence by making studies more adaptive, efficient, and patient-centric. In Latin America, the adoption of methodologies such as platform trials, master protocols, adaptive designs, and decentralized clinical trials (DCTs) is gaining traction—offering opportunities to accelerate access to innovative therapies and strengthen regional research capabilities.
This session will feature a range of perspectives—including regulators, clinical operations experts, and academic leaders—who will present case studies and experiences implementing innovative designs in the region. Topics will include how flexible methodologies have been applied to real-world clinical research in oncology and rare diseases, the evolving regulatory landscape supporting these approaches, and lessons learned in managing operational complexity and ethical oversight.
Attendees will also explore how stakeholder collaboration, digital tools, and infrastructure development are critical enablers for the wider adoption of these models. The session will conclude with a dialogue on how Latin America can enhance its readiness and leadership in the global transition toward smarter, more resilient clinical research frameworks.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Define core concepts of adaptive, platform, and decentralized clinical trial designs
- Apply practical examples of these designs to their own regulatory or operational contexts
- Assess key regulatory and infrastructure needs for implementing innovative methodologies in Latin America
- Promote stakeholder collaboration to scale up research innovation across the region
Speaker(s)
Innovative Trial Designs: Accelerating Access Through Smarter Evidence
Associate Director, Principal Clinical Site Lead LATAM, Merck Group, Argentina
Speaker
Head of Clinical Trials Department, ANMAT Ministry of Health, Argentina
Speaker
Global Regulatory Policy Lead-LatAm, Merck Sharp & Dohme LLC , United States
Speaker
President, Cámara Argentina de Organizaciones de Investigación Clínica (CAOIC), Argentina
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