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Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned
- Daniel F. Hanley, Jr, Gordon R. Bernard, Consuelo H. Wilkins, Harry P. Selker, Jamie P. Dwyer, J. Michael Dean, Daniel Kelly Benjamin, Jr, Sarah E. Dunsmore, Salina P. Waddy, Kenneth L. Wiley, Jr, Marisha E. Palm, W. Andrew Mould, Daniel F. Ford, Jeri S. Burr, Jacqueline Huvane, Karen Lane, Lori Poole, Terri L. Edwards, Nan Kennedy, Leslie R. Boone, Jasmine Bell, Emily Serdoz, Loretta M. Byrne, Paul A. Harris
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- Journal:
- Journal of Clinical and Translational Science / Volume 7 / Issue 1 / 2023
- Published online by Cambridge University Press:
- 25 July 2023, e170
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- Article
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- Open access
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New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
Contributors
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- By Basem Abdelmalak, Joseph Abdelmalak, Alaa A. Abd-Elsayed, David L. Adams, Eric E. Adelman, Maged Argalious, Endrit Bala, Gene H. Barnett, Sheron Beltran, Andrew Bielaczyc, William Bingaman, James M. Blum, Alina Bodas, Vera Borzova, Richard Bowers, Adam Brown, Chad M. Brummett, Alexandra S. Bullough, James F. Burke, Juan P. Cata, Neeraj Chaudhary, Michael J. Claybon, Miguel Cruz, Milind Deogaonkar, Vikram Dhawan, Thomas Didier, D. John Doyle, Zeyd Ebrahim, Hesham Elsharkawy, Wael Ali Sakr Esa, Ehab Farag, Ryen D. Fons, Joseph J. Gemmete, Matt Giles, Phil Gillen, Goodarz Golmirzaie, Marcos Gomes, Lisa Grilly, Maged Guirguis, David W. Healy, Heather Hervey-Jumper, Shawn L. Hervey-Jumper, Paul E. Hilliard, Samuel A. Irefin, George K. Istaphanous, Teresa L. Jacobs, Ellen Janke, Greta Jo, James W. Jones, Rami Karroum, Allen Keebler, Stephen J. Kimatian, Colleen G. Koch, Robert Scott Kriss, Andrea Kurz, Jia Lin, Michael D. Maile, Negmeldeen F. Mamoun, Mariel Manlapaz, Edward Manno, Donn Marciniak, Piyush Mathur, Nicholas F. Marko, Matthew Martin, George A. Mashour, Marco Maurtua, Scott T. McCardle, Julie McClelland, Uma Menon, Paul S. Moor, Laurel E. Moore, Ruairi Moulding, Dileep R. Nair, Todd Nelson, Julie Niezgoda, Edward Noguera, Jerome O’Hara, Aditya S. Pandey, Mauricio Perilla, Paul Picton, Marc J. Popovich, J. Javier Provencio, Venkatakrishna Rajajee, Mohit Rastogi, Stacy Ritzman, Lauryn R. Rochlen, Leif Saager, Vivek Sabharwal, Oren Sagher, Kenneth Saliba, Milad Sharifpour, Lesli E. Skolarus, Paul Smythe, Wolf H. Stapelfeldt, William R. Stetler, Peter Stiles, Vijay Tarnal, Khoi D. Than, B. Gregory Thompson, Alparslan Turan, Christopher R. Turner, Justin Upp, Sumeet Vadera, Jennifer Vance, Anthony C. Wang, Robert J. Weil, Marnie B. Welch, Karen K. Wilkins, Erin S. Williams, George N. Youssef, Asma Zakaria, Sherif S. Zaky, Andrew Zura
- Edited by George A. Mashour, Ehab Farag
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- Book:
- Case Studies in Neuroanesthesia and Neurocritical Care
- Published online:
- 03 May 2011
- Print publication:
- 03 February 2011, pp x-xvi
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Transport of proteins into chloroplasts
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- By Julie W. Meadows, University of Warwick, Jamie B. Shackleton, University of Warwick, Diane C. Bassham, University of Warwick, Ruth M. Mould, University of Warwick, Andrew Hulford, University of Warwick, Colin Robinson, University of Warwick
- Edited by Alyson K. Tobin, University of Manchester
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- Book:
- Plant Organelles
- Published online:
- 05 December 2011
- Print publication:
- 15 October 1992, pp 281-292
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Summary
All cells transport proteins across membranes, but the complexity of protein traffic in plant cells is especially striking because of the variety of organelle types involved. Many proteins are inserted, during translation, into the lumen of the endoplasmic reticulum, after which they are transported via the endomembrane system to the Golgi apparatus, vacuole, protein bodies or plasma membrane. Other proteins are transported posttranslationally into glyoxysomes, mitochondria and plastids. In each case, the protein is synthesised with an appropriate signal which ensures targeting to the correct organelle, and a number of studies have attempted to define the characteristics of these targeting signals (reviewed by Bennett & Osteryoung, 1991; Robinson, 1991).
In terms of protein transport events, the biogenesis of the chloroplast is particularly complex, primarily owing to the architecture of the organelle. The chloroplast is bounded by a double-membrane envelope, between whose membranes is a soluble phase, the functions of which are presently obscure. Within the organelle is the soluble stromal phase (site of CO2 fixation, amino acid synthesis and many other key reactions) and the extensive internal thylakoid membrane. The thylakoid network also encloses a further soluble phase, usually termed the thylakoid lumen. Thus, the chloroplast comprises in total three distinct membranes and three discrete soluble phases. Most of the proteins located in each of these organellar compartments are encoded by nuclear genes, synthesised in the cytosol, and transported into the organelle. Clearly, therefore, chloroplast biogenesis requires both the specific, efficient targeting of a large number proteins into the organelle, and the operation of intraorganellar ‘sorting’ mechanisms to distribute imported proteins to their correct destinations.