03881nam a22005055i 4500001001800000003000900018005001700027007001500044008004100059020001800100024003500118050001400153072001600167072002300183072001500206245015300221250001800374264006900392300003400461336002600495337002600521338003600547347002400583505021600607520191300823650001802736650003302754650002402787650002302811650002302834650001802857650001802875650002302893650002502916650003902941650001802980700007502998700008803073710003403161773002603195776003603221776003603257776003603293856004603329978-3-031-62877-1DE-He21320251030113229.0cr nn 008mamaa241016s2024    sz |    s    |||| 0|eng d  a97830316287717 a10.1007/978-3-031-62877-12doi 4aRM300-666 7aMMG2bicssc 7aMED0710002bisacsh 7aMKG2thema10aFundamentals of Decentralized Clinical Trialsh[electronic resource] :bStrategy and Execution /cedited by Anna H. Yang, Isaac R. Rodriguez-Chavez.  a1st ed. 2024. 1aCham :bSpringer Nature Switzerland :bImprint: Springer,c2024.  aXVII, 83 p.bonline resource.  atextbtxt2rdacontent  acomputerbc2rdamedia  aonline resourcebcr2rdacarrier  atext filebPDF2rda0 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.  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 The book emphasizes the significance of the FDA's draft guidance on DCTs, detailing investigator responsibilities, local health care providers' use, and essential sponsor considerations.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. 0aPharmacology. 0aClinical medicinexResearch. 0aMedicinexResearch. 0aBiologyxResearch. 0aPharmacovigilance. 0aTherapeutics.14aPharmacology.24aClinical Research.24aBiomedical Research.24aDrug Safety and Pharmacovigilance.24aTherapeutics.1 aYang, Anna H.eeditor.4edt4http://id.loc.gov/vocabulary/relators/edt1 aRodriguez-Chavez, Isaac R.eeditor.4edt4http://id.loc.gov/vocabulary/relators/edt2 aSpringerLink (Online service)0 tSpringer Nature eBook08iPrinted edition:z978303162876408iPrinted edition:z978303162878808iPrinted edition:z978303162879540uhttps://doi.org/10.1007/978-3-031-62877-1