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International Clinical Trials

Top 10 Factors to Design and Deploy a Decentralised Clinical Trial


The evolution of clinical research has been shaped by multiple factors that reflect the present need to create novel trial designs with optimised efficiencies. Modern trial design and deployment embraces individuals early and follows participant-centric approaches. Many trial-related activities are brought to participants in the environments where they live, contrasting with traditional trials in which participants frequently travel to distant sites. However, the main goal of modern and traditional trials is the same, both are designed to evaluate the safety and efficacy of new medical products. In both cases, this is accomplished with the same level of regulatory and legal expectation of maintaining participantsí safety and privacy, while ensuring data quality and integrity. Modern clinical trials achieve this with a greater level of convenience, access for diverse races and ethnicities, and often a higher level of engagement and retention of participants.

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About the Author

Dr Isaac Rodriguez-Chavez is Senior Vice President, Scientific and Clinical Affairs and decentralised clinical trials at ICON. He is a biomedical leader with expertise in virology, microbiology, immunology, vaccinology, and viral oncology. His expertise spans basic, translational, preclinical, and clinical research (Phase I-IV global trials). He also has expertise in digital health technologies, clinical research development and operations, regulatory affairs, approval or licensure of medical products, and quality control and quality assurance. Overall, Isaac has more than 32 years of work experience in several national and international organisations, including the FDA, NIH, and industry and non-profit research organisations. He has a BSc in Biology (Venezuela), MSc in Microbiology (Venezuela), MHSc in Clinical Research (Duke School of Medicine, US), and a PhD in Virology and Immunology (University of Delaware, US). Isaac completed two postdoctoral trainings in viral immunology and viral oncology at the National Institute on Aging and the National Cancer Institute at NIH, US.
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