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Development, implementation, and dissemination of operational innovations across the trial innovation network
- Marisha E. Palm, Terri L. Edwards, Cortney Wieber, Marie T. Kay, Eve Marion, Leslie Boone, Angeline Nanni, Michelle Jones, Eilene Pham, Meghan Hildreth, Karen Lane, Nichol McBee, Daniel K. Benjamin, Jr, Gordon R. Bernard, J. Michael Dean, Jamie P. Dwyer, Daniel E. Ford, Daniel F. Hanley, Paul A. Harris, Consuelo H. Wilkins, Harry P. Selker
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- Journal:
- Journal of Clinical and Translational Science / Volume 7 / Issue 1 / 2023
- Published online by Cambridge University Press:
- 20 October 2023, e251
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Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.
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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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.
Characterisation of age and polarity at onset in bipolar disorder
- Janos L. Kalman, Loes M. Olde Loohuis, Annabel Vreeker, Andrew McQuillin, Eli A. Stahl, Douglas Ruderfer, Maria Grigoroiu-Serbanescu, Georgia Panagiotaropoulou, Stephan Ripke, Tim B. Bigdeli, Frederike Stein, Tina Meller, Susanne Meinert, Helena Pelin, Fabian Streit, Sergi Papiol, Mark J. Adams, Rolf Adolfsson, Kristina Adorjan, Ingrid Agartz, Sofie R. Aminoff, Heike Anderson-Schmidt, Ole A. Andreassen, Raffaella Ardau, Jean-Michel Aubry, Ceylan Balaban, Nicholas Bass, Bernhard T. Baune, Frank Bellivier, Antoni Benabarre, Susanne Bengesser, Wade H Berrettini, Marco P. Boks, Evelyn J. Bromet, Katharina Brosch, Monika Budde, William Byerley, Pablo Cervantes, Catina Chillotti, Sven Cichon, Scott R. Clark, Ashley L. Comes, Aiden Corvin, William Coryell, Nick Craddock, David W. Craig, Paul E. Croarkin, Cristiana Cruceanu, Piotr M. Czerski, Nina Dalkner, Udo Dannlowski, Franziska Degenhardt, Maria Del Zompo, J. Raymond DePaulo, Srdjan Djurovic, Howard J. Edenberg, Mariam Al Eissa, Torbjørn Elvsåshagen, Bruno Etain, Ayman H. Fanous, Frederike Fellendorf, Alessia Fiorentino, Andreas J. Forstner, Mark A. Frye, Janice M. Fullerton, Katrin Gade, Julie Garnham, Elliot Gershon, Michael Gill, Fernando S. Goes, Katherine Gordon-Smith, Paul Grof, Jose Guzman-Parra, Tim Hahn, Roland Hasler, Maria Heilbronner, Urs Heilbronner, Stephane Jamain, Esther Jimenez, Ian Jones, Lisa Jones, Lina Jonsson, Rene S. Kahn, John R. Kelsoe, James L. Kennedy, Tilo Kircher, George Kirov, Sarah Kittel-Schneider, Farah Klöhn-Saghatolislam, James A. Knowles, Thorsten M. Kranz, Trine Vik Lagerberg, Mikael Landen, William B. Lawson, Marion Leboyer, Qingqin S. Li, Mario Maj, Dolores Malaspina, Mirko Manchia, Fermin Mayoral, Susan L. McElroy, Melvin G. McInnis, Andrew M. McIntosh, Helena Medeiros, Ingrid Melle, Vihra Milanova, Philip B. Mitchell, Palmiero Monteleone, Alessio Maria Monteleone, Markus M. Nöthen, Tomas Novak, John I. Nurnberger, Niamh O'Brien, Kevin S. O'Connell, Claire O'Donovan, Michael C. O'Donovan, Nils Opel, Abigail Ortiz, Michael J. Owen, Erik Pålsson, Carlos Pato, Michele T. Pato, Joanna Pawlak, Julia-Katharina Pfarr, Claudia Pisanu, James B. Potash, Mark H Rapaport, Daniela Reich-Erkelenz, Andreas Reif, Eva Reininghaus, Jonathan Repple, Hélène Richard-Lepouriel, Marcella Rietschel, Kai Ringwald, Gloria Roberts, Guy Rouleau, Sabrina Schaupp, William A Scheftner, Simon Schmitt, Peter R. Schofield, K. Oliver Schubert, Eva C. Schulte, Barbara Schweizer, Fanny Senner, Giovanni Severino, Sally Sharp, Claire Slaney, Olav B. Smeland, Janet L. Sobell, Alessio Squassina, Pavla Stopkova, John Strauss, Alfonso Tortorella, Gustavo Turecki, Joanna Twarowska-Hauser, Marin Veldic, Eduard Vieta, John B. Vincent, Wei Xu, Clement C. Zai, Peter P. Zandi, Psychiatric Genomics Consortium (PGC) Bipolar Disorder Working Group, International Consortium on Lithium Genetics (ConLiGen), Colombia-US Cross Disorder Collaboration in Psychiatric Genetics, Arianna Di Florio, Jordan W. Smoller, Joanna M. Biernacka, Francis J. McMahon, Martin Alda, Bertram Müller-Myhsok, Nikolaos Koutsouleris, Peter Falkai, Nelson B. Freimer, Till F.M. Andlauer, Thomas G. Schulze, Roel A. Ophoff
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- Journal:
- The British Journal of Psychiatry / Volume 219 / Issue 6 / December 2021
- Published online by Cambridge University Press:
- 25 August 2021, pp. 659-669
- Print publication:
- December 2021
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Background
Studying phenotypic and genetic characteristics of age at onset (AAO) and polarity at onset (PAO) in bipolar disorder can provide new insights into disease pathology and facilitate the development of screening tools.
AimsTo examine the genetic architecture of AAO and PAO and their association with bipolar disorder disease characteristics.
MethodGenome-wide association studies (GWASs) and polygenic score (PGS) analyses of AAO (n = 12 977) and PAO (n = 6773) were conducted in patients with bipolar disorder from 34 cohorts and a replication sample (n = 2237). The association of onset with disease characteristics was investigated in two of these cohorts.
ResultsEarlier AAO was associated with a higher probability of psychotic symptoms, suicidality, lower educational attainment, not living together and fewer episodes. Depressive onset correlated with suicidality and manic onset correlated with delusions and manic episodes. Systematic differences in AAO between cohorts and continents of origin were observed. This was also reflected in single-nucleotide variant-based heritability estimates, with higher heritabilities for stricter onset definitions. Increased PGS for autism spectrum disorder (β = −0.34 years, s.e. = 0.08), major depression (β = −0.34 years, s.e. = 0.08), schizophrenia (β = −0.39 years, s.e. = 0.08), and educational attainment (β = −0.31 years, s.e. = 0.08) were associated with an earlier AAO. The AAO GWAS identified one significant locus, but this finding did not replicate. Neither GWAS nor PGS analyses yielded significant associations with PAO.
ConclusionsAAO and PAO are associated with indicators of bipolar disorder severity. Individuals with an earlier onset show an increased polygenic liability for a broad spectrum of psychiatric traits. Systematic differences in AAO across cohorts, continents and phenotype definitions introduce significant heterogeneity, affecting analyses.
The Recruitment Innovation Center: Developing novel, person-centered strategies for clinical trial recruitment and retention
- Consuelo H. Wilkins, Terri L. Edwards, Mary Stroud, Nan Kennedy, Rebecca N. Jerome, Colleen E. Lawrence, Sheila V. Kusnoor, Sarah Nelson, Loretta M. Byrne, Leslie R. Boone, Julia Dunagan, Tiffany Israel, Casey Rodweller, Bethany Drury, Rhonda G. Kost, Jill M. Pulley, Gordon R. Bernard, Paul A. Harris
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- Journal:
- Journal of Clinical and Translational Science / Volume 5 / Issue 1 / 2021
- Published online by Cambridge University Press:
- 19 August 2021, e194
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Clinical trials continue to face significant challenges in participant recruitment and retention. The Recruitment Innovation Center (RIC), part of the Trial Innovation Network (TIN), has been funded by the National Center for Advancing Translational Sciences of the National Institutes of Health to develop innovative strategies and technologies to enhance participant engagement in all stages of multicenter clinical trials. In collaboration with investigator teams and liaisons at Clinical and Translational Science Award institutions, the RIC is charged with the mission to design, field-test, and refine novel resources in the context of individual clinical trials. These innovations are disseminated via newsletters, publications, a virtual toolbox on the TIN website, and RIC-hosted collaboration webinars. The RIC has designed, implemented, and promised customized recruitment support for 173 studies across many diverse disease areas. This support has incorporated site feasibility assessments, community input sessions, recruitment materials recommendations, social media campaigns, and an array of study-specific suggestions. The RIC’s goal is to evaluate the efficacy of these resources and provide access to all investigating teams, so that more trials can be completed on time, within budget, with diverse participation, and with enough accrual to power statistical analyses and make substantive contributions to the advancement of healthcare.
Response of the trial innovation network to the COVID-19 pandemic
- Rachel G. Greenberg, Lori Poole, Daniel E. Ford, Daniel Hanley, Harry P. Selker, Karen Lane, J. Michael Dean, Jeri Burr, Paul Harris, Consuelo H. Wilkins, Gordon Bernard, Terri Edwards, Daniel K. Benjamin, Jr
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- Journal:
- Journal of Clinical and Translational Science / Volume 5 / Issue 1 / 2021
- Published online by Cambridge University Press:
- 20 April 2021, e100
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Introduction:
The COVID-19 pandemic prompted the development and implementation of hundreds of clinical trials across the USA. The Trial Innovation Network (TIN), funded by the National Center for Advancing Translational Sciences, was an established clinical research network that pivoted to respond to the pandemic.
Methods:The TIN’s three Trial Innovation Centers, Recruitment Innovation Center, and 66 Clinical and Translational Science Award Hub institutions, collaborated to adapt to the pandemic’s rapidly changing landscape, playing central roles in the planning and execution of pivotal studies addressing COVID-19. Our objective was to summarize the results of these collaborations and lessons learned.
Results:The TIN provided 29 COVID-related consults between March 2020 and December 2020, including 6 trial participation expressions of interest and 8 community engagement studios from the Recruitment Innovation Center. Key lessons learned from these experiences include the benefits of leveraging an established infrastructure, innovations surrounding remote research activities, data harmonization and central safety reviews, and early community engagement and involvement.
Conclusions:Our experience highlighted the benefits and challenges of a multi-institutional approach to clinical research during a pandemic.
Equipoise and research in the current COVID-19 pandemic
- Jill M. Pulley, Rebecca N. Jerome, Todd W. Rice, Christopher J. Lindsell, Paul A. Harris, Terri L. Edwards, Consuelo H. Wilkins, Gordon R. Bernard
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- Journal of Clinical and Translational Science / Volume 5 / Issue 1 / 2021
- Published online by Cambridge University Press:
- 15 May 2020, e7
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To end disease tomorrow, begin with trials today: Digital strategies for increased awareness of a clinical trials finder
- Rebecca N. Jerome, Leah Dunkel, Nan Kennedy, Erik J. Olson, Jill M. Pulley, Gordon Bernard, Consuelo H. Wilkins, Paul A. Harris
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- Journal:
- Journal of Clinical and Translational Science / Volume 3 / Issue 4 / August 2019
- Published online by Cambridge University Press:
- 20 August 2019, pp. 190-198
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Introduction:
Individuals experiencing different medical conditions, as well as healthy volunteers, may often be interested in trial participation, and researchers similarly need to find participants to advance medical knowledge. The ResearchMatch (RM) Trials Today clinical trial searching tool leverages clinicaltrials.gov data to enable potential participants to look for trial opportunities relevant to their situation. To facilitate expanded use of this tool, we undertook a national digital public awareness campaign to increase awareness of Trials Today among members of the general public.
Methods:The awareness campaign promoted Trials Today using Facebook and digital banner messages in 2017, encompassing nine cities across the USA. The digital strategy was complemented by print media in several outlets. We employed descriptive statistics to summarize campaign metrics and site usage data during the campaign.
Results:The campaign was successful in increasing visits to Trials Today, with 142,303 sessions logged during its run, as compared to pre-campaign data indicating 104,688 total sessions during the entire 2-year period since the site’s inception. The city-specific click-through rate for all digital impressions, combining Facebook and banner messaging, ranged from 0.50% to 1.09%, resulting in a cost-per-click range of $0.69–$1.15. In addition, visitors conducted 29,697 searches and viewed individual trial records 173,512 times.
Conclusion:The public awareness campaign was successful in increasing use of the RM Trials Today clinical trial searching tool. Our findings support the value of digital media messaging as a cost-effective vehicle for promoting clinical trial awareness, especially for chronic ailments.
Connecting the public with clinical trial options: The ResearchMatch Trials Today tool
- Jill M. Pulley, Rebecca N. Jerome, Gordon R. Bernard, Erik J. Olson, Jason Tan, Consuelo H. Wilkins, Paul A. Harris
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- Journal:
- Journal of Clinical and Translational Science / Volume 2 / Issue 4 / August 2018
- Published online by Cambridge University Press:
- 27 November 2018, pp. 253-257
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Potential participants seek information about clinical trials for many reasons, but the process can be challenging. We analyzed 101,249 searches in ResearchMatch Trials Today, a free interface to recruiting trials from ClinicalTrials.gov. Searches from March 2015 to November 2016 included a broad range of conditions and healthy volunteer concepts, including 12,649 unique topics. Trials Today data indicate that it is being used to identify trials on a variety of topics.
A collaborative, academic approach to optimizing the national clinical research infrastructure: The first year of the Trial Innovation Network
- Gordon R. Bernard, Paul A. Harris, Jill M. Pulley, Daniel K. Benjamin, Jonathan Michael Dean, Daniel E. Ford, Daniel F. Hanley, Harry P. Selker, Consuelo H. Wilkins
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- Journal of Clinical and Translational Science / Volume 2 / Issue 4 / August 2018
- Published online by Cambridge University Press:
- 27 November 2018, pp. 187-192
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Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science—sponsored Clinical and Translational Science Award (CTSA) program is able to address such inefficiencies. The Trial Innovation Network (TIN) is a collaborative initiative with the CTSA program and other National Institutes of Health (NIH) Institutes and Centers that addresses critical roadblocks to accelerate the translation of novel interventions to clinical practice. The TIN’s mission is to execute high-quality trials in a quick, cost-efficient manner. The TIN awardees are composed of 3 Trial Innovation Centers, the Recruitment Innovation Center, and the individual CTSA institutions that have identified TIN Liaison units. The TIN has launched a national scale single (central) Institutional Review Board system, master contracting agreements, quality-by-design approaches, novel recruitment support methods, and applies evidence-based strategies to recruitment and patient engagement. The TIN has received 113 submissions from 39 different CTSA institutions and 8 non-CTSA Institutions, with projects associated with 12 different NIH Institutes and Centers across a wide range of clinical/disease areas. Already more than 150 unique health systems/organizations are involved as sites in TIN-related multisite studies. The TIN will begin to capture data and metrics that quantify increased efficiency and quality improvement during operations.
The International Trans-Antarctic Scientific Expedition (ITASE): an overview
- Paul Andrew Mayewski, Massimo Frezzotti, Nancy Bertler, Tas VAN Ommen, Gordon Hamilton, Tim H. Jacka, Brian Welch, Markus Frey, Qin Dahe, Ren Jiawen, Jefferson Simões, Michel Fily, Hans Oerter, Fumihiko Nishio, Elisabeth Isaksson, Robert Mulvaney, Per Holmund, Volodya Lipenkov, Ian Goodwin
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- Journal:
- Annals of Glaciology / Volume 41 / 2005
- Published online by Cambridge University Press:
- 14 September 2017, pp. 180-185
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From its original formulation in 1990 the International Trans-Antarctic Scientific Expedition (ITASE) has had as its primary aim the collection and interpretation of a continent-wide array of environmental parameters assembled through the coordinated efforts of scientists from several nations. ITASE offers the ground-based opportunities of traditional-style traverse travel coupled with the modern technology of GPS, crevasse detecting radar, satellite communications and multidisciplinary research. By operating predominantly in the mode of an oversnow traverse, ITASE offers scientists the opportunity to experience the dynamic range of the Antarctic environment. ITASE also offers an important interactive venue for research similar to that afforded by oceanographic research vessels and large polar field camps, without the cost of the former or the lack of mobility of the latter. More importantly, the combination of disciplines represented by ITASE provides a unique, multidimensional (space and time) view of the ice sheet and its history. ITASE has now collected >20 000km of snow radar, recovered more than 240 firn/ice cores (total length 7000 m), remotely penetrated to ~4000m into the ice sheet, and sampled the atmosphere to heights of >20 km.
Effect of Postemergence Glyphosate Application Timing on Weed Control and Grain Yield in Glyphosate-Resistant Corn: Results of a 2-Yr Multistate Study
- Steven A. Gower, Mark M. Loux, John Cardina, S. Kent Harrison, Paul L. Sprankle, Norman J. Probst, Thomas T. Bauman, Wayne Bugg, W. S. Curran, Randall S. Currie, R. Gordon Harvey, William G. Johnson, James J. Kells, Micheal D. K. Owen, David L. Regehr, Charles H. Slack, Marvin Spaur, Christy L. Sprague, Mark Vangessel, Bryan G. Young
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- Weed Technology / Volume 17 / Issue 4 / December 2003
- Published online by Cambridge University Press:
- 20 January 2017, pp. 821-828
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Field studies were conducted at 35 sites throughout the north-central United States in 1998 and 1999 to determine the effect of postemergence glyphosate application timing on weed control and grain yield in glyphosate-resistant corn. Glyphosate was applied at various timings based on the height of the most dominant weed species. Weed control and corn grain yields were considerably more variable when glyphosate was applied only once. The most effective and consistent season-long annual grass and broadleaf weed control occurred when a single glyphosate application was delayed until weeds were 15 cm or taller. Two glyphosate applications provided more consistent weed control when weeds were 10 cm tall or less and higher corn grain yields when weeds were 5 cm tall or less, compared with a single application. Weed control averaged at least 94 and 97% across all sites in 1998 and 1999, respectively, with two glyphosate applications but was occasionally less than 70% because of late emergence of annual grass and Amaranthus spp. or reduced control of Ipomoea spp. With a single application of glyphosate, corn grain yield was most often reduced when the application was delayed until weeds were 23 cm or taller. Averaged across all sites in 1998 and 1999, corn grain yields from a single glyphosate application at the 5-, 10-, 15-, 23-, and 30-cm timings were 93, 94, 93, 91, and 79% of the weed-free control, respectively. There was a significant effect of herbicide treatment on corn grain yield in 23 of the 35 sites when weed reinfestation was prevented with a second glyphosate application. When weed reinfestation was prevented, corn grain yield at the 5-, 10-, and 15-cm application timings was 101, 97, and 93% of the weed-free control, respectively, averaged across all sites. Results of this study suggested that the optimum timing for initial glyphosate application to avoid corn grain yield loss was when weeds were less than 10 cm in height, no more than 23 d after corn planting, and when corn growth was not more advanced than the V4 stage.
Contributors
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- By Mitchell Aboulafia, Frederick Adams, Marilyn McCord Adams, Robert M. Adams, Laird Addis, James W. Allard, David Allison, William P. Alston, Karl Ameriks, C. Anthony Anderson, David Leech Anderson, Lanier Anderson, Roger Ariew, David Armstrong, Denis G. Arnold, E. J. Ashworth, Margaret Atherton, Robin Attfield, Bruce Aune, Edward Wilson Averill, Jody Azzouni, Kent Bach, Andrew Bailey, Lynne Rudder Baker, Thomas R. Baldwin, Jon Barwise, George Bealer, William Bechtel, Lawrence C. Becker, Mark A. Bedau, Ernst Behler, José A. Benardete, Ermanno Bencivenga, Jan Berg, Michael Bergmann, Robert L. Bernasconi, Sven Bernecker, Bernard Berofsky, Rod Bertolet, Charles J. Beyer, Christian Beyer, Joseph Bien, Joseph Bien, Peg Birmingham, Ivan Boh, James Bohman, Daniel Bonevac, Laurence BonJour, William J. Bouwsma, Raymond D. Bradley, Myles Brand, Richard B. Brandt, Michael E. Bratman, Stephen E. Braude, Daniel Breazeale, Angela Breitenbach, Jason Bridges, David O. Brink, Gordon G. Brittan, Justin Broackes, Dan W. Brock, Aaron Bronfman, Jeffrey E. Brower, Bartosz Brozek, Anthony Brueckner, Jeffrey Bub, Lara Buchak, Otavio Bueno, Ann E. Bumpus, Robert W. Burch, John Burgess, Arthur W. Burks, Panayot Butchvarov, Robert E. Butts, Marina Bykova, Patrick Byrne, David Carr, Noël Carroll, Edward S. Casey, Victor Caston, Victor Caston, Albert Casullo, Robert L. Causey, Alan K. L. Chan, Ruth Chang, Deen K. Chatterjee, Andrew Chignell, Roderick M. Chisholm, Kelly J. Clark, E. J. Coffman, Robin Collins, Brian P. Copenhaver, John Corcoran, John Cottingham, Roger Crisp, Frederick J. Crosson, Antonio S. Cua, Phillip D. Cummins, Martin Curd, Adam Cureton, Andrew Cutrofello, Stephen Darwall, Paul Sheldon Davies, Wayne A. Davis, Timothy Joseph Day, Claudio de Almeida, Mario De Caro, Mario De Caro, John Deigh, C. F. Delaney, Daniel C. Dennett, Michael R. DePaul, Michael Detlefsen, Daniel Trent Devereux, Philip E. Devine, John M. Dillon, Martin C. Dillon, Robert DiSalle, Mary Domski, Alan Donagan, Paul Draper, Fred Dretske, Mircea Dumitru, Wilhelm Dupré, Gerald Dworkin, John Earman, Ellery Eells, Catherine Z. Elgin, Berent Enç, Ronald P. Endicott, Edward Erwin, John Etchemendy, C. Stephen Evans, Susan L. Feagin, Solomon Feferman, Richard Feldman, Arthur Fine, Maurice A. Finocchiaro, William FitzPatrick, Richard E. Flathman, Gvozden Flego, Richard Foley, Graeme Forbes, Rainer Forst, Malcolm R. Forster, Daniel Fouke, Patrick Francken, Samuel Freeman, Elizabeth Fricker, Miranda Fricker, Michael Friedman, Michael Fuerstein, Richard A. Fumerton, Alan Gabbey, Pieranna Garavaso, Daniel Garber, Jorge L. A. Garcia, Robert K. Garcia, Don Garrett, Philip Gasper, Gerald Gaus, Berys Gaut, Bernard Gert, Roger F. Gibson, Cody Gilmore, Carl Ginet, Alan H. Goldman, Alvin I. Goldman, Alfonso Gömez-Lobo, Lenn E. Goodman, Robert M. Gordon, Stefan Gosepath, Jorge J. E. Gracia, Daniel W. Graham, George A. Graham, Peter J. Graham, Richard E. Grandy, I. Grattan-Guinness, John Greco, Philip T. Grier, Nicholas Griffin, Nicholas Griffin, David A. Griffiths, Paul J. Griffiths, Stephen R. Grimm, Charles L. Griswold, Charles B. Guignon, Pete A. Y. Gunter, Dimitri Gutas, Gary Gutting, Paul Guyer, Kwame Gyekye, Oscar A. Haac, Raul Hakli, Raul Hakli, Michael Hallett, Edward C. Halper, Jean Hampton, R. James Hankinson, K. R. Hanley, Russell Hardin, Robert M. Harnish, William Harper, David Harrah, Kevin Hart, Ali Hasan, William Hasker, John Haugeland, Roger Hausheer, William Heald, Peter Heath, Richard Heck, John F. Heil, Vincent F. Hendricks, Stephen Hetherington, Francis Heylighen, Kathleen Marie Higgins, Risto Hilpinen, Harold T. Hodes, Joshua Hoffman, Alan Holland, Robert L. Holmes, Richard Holton, Brad W. Hooker, Terence E. Horgan, Tamara Horowitz, Paul Horwich, Vittorio Hösle, Paul Hoβfeld, Daniel Howard-Snyder, Frances Howard-Snyder, Anne Hudson, Deal W. Hudson, Carl A. Huffman, David L. Hull, Patricia Huntington, Thomas Hurka, Paul Hurley, Rosalind Hursthouse, Guillermo Hurtado, Ronald E. Hustwit, Sarah Hutton, Jonathan Jenkins Ichikawa, Harry A. Ide, David Ingram, Philip J. Ivanhoe, Alfred L. Ivry, Frank Jackson, Dale Jacquette, Joseph Jedwab, Richard Jeffrey, David Alan Johnson, Edward Johnson, Mark D. Jordan, Richard Joyce, Hwa Yol Jung, Robert Hillary Kane, Tomis Kapitan, Jacquelyn Ann K. Kegley, James A. Keller, Ralph Kennedy, Sergei Khoruzhii, Jaegwon Kim, Yersu Kim, Nathan L. King, Patricia Kitcher, Peter D. Klein, E. D. Klemke, Virginia Klenk, George L. Kline, Christian Klotz, Simo Knuuttila, Joseph J. Kockelmans, Konstantin Kolenda, Sebastian Tomasz Kołodziejczyk, Isaac Kramnick, Richard Kraut, Fred Kroon, Manfred Kuehn, Steven T. Kuhn, Henry E. Kyburg, John Lachs, Jennifer Lackey, Stephen E. Lahey, Andrea Lavazza, Thomas H. Leahey, Joo Heung Lee, Keith Lehrer, Dorothy Leland, Noah M. Lemos, Ernest LePore, Sarah-Jane Leslie, Isaac Levi, Andrew Levine, Alan E. Lewis, Daniel E. Little, Shu-hsien Liu, Shu-hsien Liu, Alan K. L. Chan, Brian Loar, Lawrence B. Lombard, John Longeway, Dominic McIver Lopes, Michael J. Loux, E. J. Lowe, Steven Luper, Eugene C. Luschei, William G. Lycan, David Lyons, David Macarthur, Danielle Macbeth, Scott MacDonald, Jacob L. Mackey, Louis H. Mackey, Penelope Mackie, Edward H. Madden, Penelope Maddy, G. B. Madison, Bernd Magnus, Pekka Mäkelä, Rudolf A. Makkreel, David Manley, William E. Mann (W.E.M.), Vladimir Marchenkov, Peter Markie, Jean-Pierre Marquis, Ausonio Marras, Mike W. Martin, A. P. Martinich, William L. McBride, David McCabe, Storrs McCall, Hugh J. McCann, Robert N. McCauley, John J. McDermott, Sarah McGrath, Ralph McInerny, Daniel J. McKaughan, Thomas McKay, Michael McKinsey, Brian P. McLaughlin, Ernan McMullin, Anthonie Meijers, Jack W. Meiland, William Jason Melanson, Alfred R. Mele, Joseph R. Mendola, Christopher Menzel, Michael J. Meyer, Christian B. Miller, David W. Miller, Peter Millican, Robert N. Minor, Phillip Mitsis, James A. Montmarquet, Michael S. Moore, Tim Moore, Benjamin Morison, Donald R. Morrison, Stephen J. Morse, Paul K. Moser, Alexander P. D. Mourelatos, Ian Mueller, James Bernard Murphy, Mark C. Murphy, Steven Nadler, Jan Narveson, Alan Nelson, Jerome Neu, Samuel Newlands, Kai Nielsen, Ilkka Niiniluoto, Carlos G. Noreña, Calvin G. Normore, David Fate Norton, Nikolaj Nottelmann, Donald Nute, David S. Oderberg, Steve Odin, Michael O’Rourke, Willard G. Oxtoby, Heinz Paetzold, George S. Pappas, Anthony J. Parel, Lydia Patton, R. P. Peerenboom, Francis Jeffry Pelletier, Adriaan T. Peperzak, Derk Pereboom, Jaroslav Peregrin, Glen Pettigrove, Philip Pettit, Edmund L. Pincoffs, Andrew Pinsent, Robert B. Pippin, Alvin Plantinga, Louis P. Pojman, Richard H. Popkin, John F. Post, Carl J. Posy, William J. Prior, Richard Purtill, Michael Quante, Philip L. Quinn, Philip L. Quinn, Elizabeth S. Radcliffe, Diana Raffman, Gerard Raulet, Stephen L. Read, Andrews Reath, Andrew Reisner, Nicholas Rescher, Henry S. Richardson, Robert C. Richardson, Thomas Ricketts, Wayne D. Riggs, Mark Roberts, Robert C. Roberts, Luke Robinson, Alexander Rosenberg, Gary Rosenkranz, Bernice Glatzer Rosenthal, Adina L. Roskies, William L. Rowe, T. M. Rudavsky, Michael Ruse, Bruce Russell, Lilly-Marlene Russow, Dan Ryder, R. M. Sainsbury, Joseph Salerno, Nathan Salmon, Wesley C. Salmon, Constantine Sandis, David H. Sanford, Marco Santambrogio, David Sapire, Ruth A. Saunders, Geoffrey Sayre-McCord, Charles Sayward, James P. Scanlan, Richard Schacht, Tamar Schapiro, Frederick F. Schmitt, Jerome B. Schneewind, Calvin O. Schrag, Alan D. Schrift, George F. Schumm, Jean-Loup Seban, David N. Sedley, Kenneth Seeskin, Krister Segerberg, Charlene Haddock Seigfried, Dennis M. Senchuk, James F. Sennett, William Lad Sessions, Stewart Shapiro, Tommie Shelby, Donald W. 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- By Rony A. Adam, Gloria Bachmann, Nichole M. Barker, Randall B. Barnes, John Bennett, Inbar Ben-Shachar, Jonathan S. Berek, Sarah L. Berga, Monica W. Best, Eric J. Bieber, Frank M. Biro, Shan Biscette, Anita K. Blanchard, Candace Brown, Ronald T. Burkman, Joseph Buscema, John E. Buster, Michael Byas-Smith, Sandra Ann Carson, Judy C. Chang, Annie N. Y. Cheung, Mindy S. Christianson, Karishma Circelli, Daniel L. Clarke-Pearson, Larry J. Copeland, Bryan D. Cowan, Navneet Dhillon, Michael P. Diamond, Conception Diaz-Arrastia, Nicole M. Donnellan, Michael L. Eisenberg, Eric Eisenhauer, Sebastian Faro, J. Stuart Ferriss, Lisa C. Flowers, Susan J. Freeman, Leda Gattoc, Claudine Marie Gayle, Timothy M. Geiger, Jennifer S. Gell, Alan N. Gordon, Victoria L. Green, Jon K. Hathaway, Enrique Hernandez, S. Paige Hertweck, Randall S. Hines, Ira R. Horowitz, Fred M. Howard, William W. Hurd, Fidan Israfilbayli, Denise J. Jamieson, Carolyn R. Jaslow, Erika B. Johnston-MacAnanny, Rohna M. Kearney, Namita Khanna, Caroline C. King, Jeremy A. King, Ira J. Kodner, Tamara Kolev, Athena P. Kourtis, S. Robert Kovac, Ertug Kovanci, William H. Kutteh, Eduardo Lara-Torre, Pallavi Latthe, Herschel W. Lawson, Ronald L. Levine, Frank W. Ling, Larry I. Lipshultz, Steven D. McCarus, Robert McLellan, Shruti Malik, Suketu M. Mansuria, Mohamed K. Mehasseb, Pamela J. Murray, Saloney Nazeer, Farr R. Nezhat, Hextan Y. S. Ngan, Gina M. Northington, Peggy A. Norton, Ruth M. O'Regan, Kristiina Parviainen, Resad P. Pasic, Tanja Pejovic, K. Ulrich Petry, Nancy A. Phillips, Ashish Pradhan, Elizabeth E. Puscheck, Suneetha Rachaneni, Devon M. Ramaeker, David B. Redwine, Robert L. Reid, Carla P. Roberts, Walter Romano, Peter G. Rose, Robert L. Rosenfield, Shon P. Rowan, Mack T. Ruffin, Janice M. Rymer, Evis Sala, Ritu Salani, Joseph S. Sanfilippo, Mahmood I. Shafi, Roger P. Smith, Meredith L. Snook, Thomas E. Snyder, Mary D. Stephenson, Thomas G. Stovall, Richard L. Sweet, Philip M. Toozs-Hobson, Togas Tulandi, Elizabeth R. Unger, Denise S. Uyar, Marion S. Verp, Rahi Victory, Tamara J. Vokes, Michelle J. Washington, Katharine O'Connell White, Paul E. Wise, Frank M. Wittmaack, Miya P. Yamamoto, Christine Yu, Howard A. Zacur
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- By Shyamkrishna Balganesh, Dan L. Burk, Eric R. Claeys, Thomas F. Cotter, Hanoch Dagan, Richard A. Epstein, Jeanne C. Fromer, Wendy J. Gordon, Paul J. Heald, Steven Hetcher, David Lametti, Mark A. Lemley, Margaret H. Lemos, Mark P. McKenna, Peter S. Menell, Gideon Parchomovsky, Lee Petherbridge, Michael Risch, Jennifer E. Rothman, Emily Sherwin, Henry E. Smith, Madhavi Sunder, Molly Shaffer Van Houweling, R. Polk Wagner, Christopher S. Yoo
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- By Albert Altchek, David H. Barad, Katharine Batt, Yuval Bdolah, Revaz Botchorishvili, Nicolas Bourdel, Michael S. Broder, Douglas N. Brown, Jubilee Brown, Antoine Maurice Bruhat, Michel Canis, Mine S. Cicek, Carmel J. Cohen, Christopher P. Crum, Christina E. Curtin, Liane Deligdisch, Philip J. Di Saia, Ramez N. Eskander, Tamara Finger, David Fishman, Brooke L. Fridley, David M. Gershenson, Norbert Gleicher, Ellen L. Goode, Pierre S. Gordon, Ioannis Gryparis, Jonathan Hecht, Wendy C. Hsiao, Eric C. Huang, Nathan G. Kase, Valentin Kolev, Lale Kostakoglu, Neri Laufer, Anna Laury, Gerard Mage, Angelica Mareş, Maurie Markman, Luciano G. Nardo, Farr R. Nezhat, Sree Durga Patchava, Tanja Pejovic, Catherine M. Phelan, Benoit Rabischong, Jamal Rahaman, David Rodriguez-Buritica, Paul Saenger, Peter Schlosshauer, William L. Simpson, Cardinale B. Smith, Jason Sternchos
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- By Victoria M. Allen, Frederic Amant, Sarah Armstrong, Thomas F. Baskett, Michael A. Belfort, Meredith Birsner, Renee D. Boss, Leanne Bricker, Josaphat K. Byamugisha, Giorgio Capogna, Michael P. Casaer, Frank A. Chervenak, Vicki Clark, Filip Claus, Malachy O. Columb, Charles Cox, Jean T. Cox, Vegard Dahl, John Davison, Jan Deprest, Clifford S. Deutschman, Roland Devlieger, Karim Djekidel, Steven Dymarkowski, Roshan Fernando, Clare Fitzpatrick, Sreedhar Gaddipati, Thierry Girard, Emily Gordon, Ian A. Greer, David Grooms, Sina Haeri, Katy Harrison, Edward J. Hayes, Michelle Hladunewich, Andra H. James, Tracey Johnston, Bellal Joseph, Erin Keely, Ruth Landau, Stephen E. Lapinsky, Susanna I. Lee, Larry Leeman, Hennie Lombaard, Stephen Lu, Alison MacArthur, Laura A. Magee, Paul E. Marik, Laurence B. McCullough, Alexandre Mignon, Carlo Missant, Jack Moodley, Lisa E. Moore, Kate Morse, Warwick D. Ngan Kee, Catherine Nelson-Piercy, Clemens M. Ortner, Geraldine O’Sullivan, Luis D. Pacheco, Fathima Paruk, Melina Pectasides, Nigel Pereira, Patricia Peticca, Sharon T. Phelan, Felicity Plaat, Lauren A. Plante, Michael P. Plevyak, Dianne Plews, Wendy Pollock, Laura C. Price, Peter Rhee, Leiv Arne Rosseland, Kathryn M. Rowan, Helen Ryan, Helen Scholefield, Neil S. Seligman, Nadir Sharawi, Alex Sia, Bob Silver, Mieke Soens, Ulrich J. Spreng, Silvia Stirparo, Nova Szoka, Andrew Tang, Kha M. Tran, Els Troost, Lawrence C. Tsen, Derek Tuffnell, Kristel Van Calsteren, Marc Van de Velde, Marcel Vercauteren, Chris Verslype, Peter von Dadelszen, Carl Waldman, Michelle Walters, Linda Watkins, Paul Westhead, Cynthia A. Wong, Gerda G. Zeeman, Joost J. Zwart
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- By Pina Amin, Sir Sabaratnam Arulkumaran, Sarah L. Bell, M. J. Blott, Hajeera Butt, Edwin Chandraharan, Joanna Crofts, Mark Denbow, Mandish K. Dhanjal, Stergios K. Doumouchtsis, Timothy J. Draycott, Rohan D'Souza, David Fraser, Guy Jackson, Nina Johns, Tracey Johnston, Justin C. Konje, Audrey Long, Louay S. Louis, Paul A. Mannix, Mahishee Mehta, Nutan Mishra, Sambit Mukhopadhyay, Deirdre J. Murphy, Vivek Nama, Osric Navti, Catherine Nelson-Piercy, Jane E. Norman, Geraldine O'Sullivan, Sara Paterson-Brown, Leonie Penna, Neelam Potdar, Helen Scholefield, Jason Scott, Dimitrios M. Siassakos, Gordon C. S. Smith, Lisa Story, Bryony Strachan, Devi Subramanian, Abdul H. Sultan, Ranee Thakar, Austin Ugwumadu, Rajesh Varma, James J. Walker, Steve Walkinshaw, Richard Warren, Melissa Whitten, Melissa K. Whitworth, Julian Woolfson, Steve Yentis
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- Best Practice in Labour and Delivery
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Early phase trials of minocycline in amyotrophic lateral sclerosis
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- By Paul H. Gordon, Department of Neurology, Columbia University, NY, USA; Email: phg8@columbia.edu, Joseph Choi, Department of Neurology, Columbia University, NY, USA; Email: phg8@columbia.edu, Dan H. Moore, Department of Biostatistics, California Pacific Medical Center, CA, USA; Email: dmoore@cc.UCSF.edu, Robert G. Miller, Department of Neurology, California Pacific Medical Center, CA, USA; Email: millerrx@sutterhealth.org
- Edited by Jeffrey L. Cummings
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Summary
Key words: amyotrophic lateral sclerosis; minocycline; clinical trial; neurodegeneration.
Introduction and Overview
Amyotrophic lateral sclerosis (ALS), a neurodegenerative disease characterized by selective motor neuron cell death, leads to progressive weakness and death in an average of 3 years (Rowland & Shneider, 2001). There is no cure or known treatment that improves function. The mechanisms of motor neuron degeneration are not fully understood, but there is evidence that mitochondrial dysfunction, free radical toxicity, glutamate excitotoxicity, and intermediate filament-aggregation lead to activation of genes and enzymes that control cell death pathways, including apoptosis (Martin, 1999; Wiedemann et al., 1998; Rothstein et al., 1992; Hirano, 1991). Up-regulation of stress enzymes such as p38 mitogen activated protein (MAP) kinase and release of mitochondrial cytochrome c may contribute to activation of pro-inflammatory and pro-apoptotic modulators (Zhu et al., 2002; Mota et al., 2001; Horstmann et al., 1998; Migheli et al., 1997; Schiffer et al., 1996). Inflammatory cells and cytokines, including inducible nitric oxide synthase (iNOS), components of the complement cascade, and pro-apoptotic caspase enzymes are activated in areas of neurodegeneration in ALS (Almer et al., 2001; Li et al., 2000; Martin et al., 2000; Kostic et al., 1997). Caspase enzyme inhibitors and anti-inflammatory agents slow progression in the transgenic mouse model of ALS (Drachman et al., 2002; Barneoud and Curet, 2000; Friedlander et al., 1997).
Minocycline, which has both anti-inflammatory and anti-apoptotic properties, crosses the blood–brain barrier, and has been shown to have neuroprotective effects in models of ALS and other neurodegenerative disorders.
Early Phase Trials of Minocycline in Amyotrophic Lateral Sclerosis
- Paul H. Gordon, Joseph Choi, Dan H. Moore, Robert G. Miller
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- Progress in Neurotherapeutics and Neuropsychopharmacology / Volume 1 / Issue 1 / January 2006
- Published online by Cambridge University Press:
- 15 February 2006, pp. 63-77
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- January 2006
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