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020 _a9783031628771
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082 0 4 _a615
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245 1 0 _aFundamentals of Decentralized Clinical Trials
_h[electronic resource] :
_bStrategy and Execution /
_cedited by Anna H. Yang, Isaac R. Rodriguez-Chavez.
250 _a1st ed. 2024.
264 1 _aCham :
_bSpringer Nature Switzerland :
_bImprint: Springer,
_c2024.
300 _aXVII, 83 p.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
_bPDF
_2rda
505 0 _a1. 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.
520 _aA 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 The book emphasizes the significance of the FDA's draft guidance on DCTs, detailing investigator responsibilities, local health care providers' use, and essential sponsor considerations.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.
541 _fUABC ;
_cPerpetuidad
650 0 _aPharmacology.
650 0 _aClinical medicine
_xResearch.
650 0 _aMedicine
_xResearch.
650 0 _aBiology
_xResearch.
650 0 _aPharmacovigilance.
650 0 _aTherapeutics.
650 1 4 _aPharmacology.
650 2 4 _aClinical Research.
650 2 4 _aBiomedical Research.
650 2 4 _aDrug Safety and Pharmacovigilance.
650 2 4 _aTherapeutics.
700 1 _aYang, Anna H.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
700 1 _aRodriguez-Chavez, Isaac R.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
710 2 _aSpringerLink (Online service)
773 0 _tSpringer Nature eBook
776 0 8 _iPrinted edition:
_z9783031628764
776 0 8 _iPrinted edition:
_z9783031628788
776 0 8 _iPrinted edition:
_z9783031628795
856 4 0 _zLibro electrónico
_uhttp://libcon.rec.uabc.mx:2048/login?url=https://doi.org/10.1007/978-3-031-62877-1
912 _aZDB-2-SBL
912 _aZDB-2-SXB
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