Fundamentals of Decentralized Clinical Trials

A timely and first-of-its-kind publication in the field, this short handbook on decentralized clinical trials (DCTs) offers a thorough exploration of the potential of DCTs to revolutionize clinical research through innovative approaches, including technology. This concise and easy-to-read publication is especially designed for those who seek to understand and get up-to-speed on what DCTs mean and how to work in this rapidly evolving field. As discussed in Chapter 1, DCTs address barriers to traditional trial participation, promoting accessibility, diversity, equity, and participant engagement. Chapter 2 examines how the COVID-19 pandemic and evolving regulations accelerated the adoption of DCTs, building on their application since the early 2000s. Chapters 3 and 4 highlight remaining operational complexities and the importance of careful trial design to ensure scientific rigor, operational feasibility, and compliance with regulations, ethics, data privacy, and participant safety. The book emphasizes the significance of the FDA's draft guidance on DCTs, detailing investigator responsibilities, local health care providers' use, and essential sponsor considerations. Chapter 5 stresses the need for clear metrics to evaluate DCT adoption's impact on recruitment, retention, diversity, safety, and cost efficiencies. Overall, this guide tracks DCT advancements and encourages readers to contribute to evidence-based integration, meeting participant expectations for convenience and fostering faster, more inclusive clinical studies. Ultimately, this book aims to support the transformation of modern clinical research, developing medical products more efficiently for those in need. A major contribution to the literature on clinical research, this work will be a resourceful tool to anyone interested in embracing decentralized clinical research and improving access and participation for all.

Offers a comprehensive introduction to what DCTs mean and how to work in this space Explains how DCTs address barriers to traditional trial participation, promoting accessibility, diversity, and equity Emphasizes the significance of the FDA's draft guidance on DCTs, detailing investigator responsibilities

Auteur

Dr. Yang is a Principal Clinical Innovation and Technology Leader in the US Medical Affairs Evidence Generation Team at Genentech. Anna leads discussions related to DCT strategy and implementation with study teams across the portfolio, infusing insights and best practices from industry partners. Anna cares deeply about inspiring change in the lagging adopters by sharing important lessons learned and reshaping assumptions. Anna is also curious about quantifying the value of DCT approaches and is actively involved with DTRA and the Tufts PACT cross-industry collaborations. Anna received her PharmD at the Rutgers Ernest Mario School of Pharmacy and completed a postdoctoral fellowship in the Genentech BioOncology Medical Science Liaisons team.

Dr. Rodriguez-Chavez is a preeminent clinical research and regulatory affairs leader who has forged a distinguished 30-year career in infectious diseases, immunology, oncology, vaccines and rare diseases. His expertise spans the entire medical product lifecycle. Previously Senior Vice President at ICON plc, spearheading DCTs and digital medicine strategies. He is also a former U.S. FDA Senior Official who developed the draft guidance on DCTs with FDA colleagues and made pivotal contributions to modernize clinical research by using digital health technologies (DHTs). He has authored 60+ publications, delivered 151+ global presentations, and his contributions on DCTs and DHTs resonate through industry, academia and non-for-profit enterprises.

Contenu

1. Introduction and overview of decentralized clinical trials.- 2. Technology landscape and requirements.- 3. Regulatory landscape.- 4. Methodology and protocol development.- 5. Goals and metrics of success.