04289nam a22005895i 4500 978-3-031-62877-1 DE-He213 20251030113229.0 cr nn 008mamaa 241016s2024 sz | s |||| 0|eng d 9783031628771 978-3-031-62877-1 10.1007/978-3-031-62877-1 doi RM300-666 MMG bicssc MED071000 bisacsh MKG thema Fundamentals of Decentralized Clinical Trials [electronic resource] : Strategy and Execution / edited by Anna H. Yang, Isaac R. Rodriguez-Chavez. 1st ed. 2024. Cham : Springer Nature Switzerland : Imprint: Springer, 2024. XVII, 83 p. online resource. text txt rdacontent computer c rdamedia online resource cr rdacarrier text file PDF rda 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. 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 The book emphasizes the significance of the FDA's draft guidance on DCTs, detailing investigator responsibilities, local health care providers' use, and essential sponsor considerations.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. Pharmacology. 67844 Clinical medicine Research. 74123 Medicine Research. 62598 Biology Research. 65629 Pharmacovigilance. 74275 Therapeutics. 70087 Pharmacology. 67844 Clinical Research. 74124 Biomedical Research. 65633 Drug Safety and Pharmacovigilance. 74276 Therapeutics. 70087 Yang, Anna H. editor. edt http://id.loc.gov/vocabulary/relators/edt 86103 Rodriguez-Chavez, Isaac R. editor. edt http://id.loc.gov/vocabulary/relators/edt 86104 SpringerLink (Online service) Springer Nature eBook Printed edition: 9783031628764 Printed edition: 9783031628788 Printed edition: 9783031628795 https://doi.org/10.1007/978-3-031-62877-1 ZDB-2-SBL ZDB-2-SXB 64237 64237