A framework for assessing clinical trial site readiness

Autor: John B. Buse, Christopher P. Austin, S. Claiborne Johnston, Freda Lewis-Hall, Andrew N. March, Carolyn K. Shore, Pamela Tenaerts, Joni L. Rutter

Publikováno v: Journal of Clinical and Translational Science, Vol 7 (2023)

Clinical trial processes are unnecessarily inefficient and costly, slowing the translation of medical discoveries into treatments for people living with disease. To reduce redundancies and inefficiencies, a group of clinical trial experts developed a

Externí odkaz: https://doaj.org/article/fe08bffcee784decbaf2cd4fdc016cc4

Regulatory Processes for Rare Disease Drugs in the United States and European Union : Flexibilities and Collaborative Opportunities

Autor: National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Committee on Processes to Evaluate the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and, Carolyn K. Shore, Tequam L. Worku, Carson W. Smith, Jeffrey P. Kahn

Rare diseases, such as sickle cell disease and thalassemia, affect up to 30 million people in the United States and at least 300 million across the globe. Congress called on the U.S. Food and Drug Administration (FDA) to sponsor a National Academies

Effect of lorcaserin on prevention and remission of type 2 diabetes in overweight and obese patients (CAMELLIA-TIMI 61): a randomised, placebo-controlled trial

Autor: Erin A Bohula, Benjamin M Scirica, Silvio E Inzucchi, Darren K McGuire, Anthony C Keech, Steven R Smith, Estella Kanevsky, Sabina A Murphy, Lawrence A Leiter, Jamie P Dwyer, Ramon Corbalan, Christian Hamm, Lee Kaplan, Jose Carlos Nicolau, Ton Oude Ophuis, Kausik K Ray, Mikhail Ruda, Jindrich Spinar, Tushar Patel, Wenfeng Miao, Carlos Perdomo, Bruce Francis, Shobha Dhadda, Marc P Bonaca, Christian T Ruff, Marc S Sabatine, Stephen D Wiviott, Silvio Inzucchi, Anthony Keech, Andrew Satlin, Conville Brown, Andrzej Budaj, Jamie Dwyer, Armando Garcia-Castillo, Milan Gupta, Kauski Ray, Neil Weissman, Harvey D White, J Amerena, M Arstall, D Colquhoun, R Jayasinghe, A Lee, R Lehman, R Moses, J Proietto, P Purnell, J Waites, P Blombery, D Cross, M Worthley, M d'Emden, J Selvanayagam, RE Oqueli, A Whelan, P Garrahy, F de Looze, D Ninio, J Horowitz, M William, M Suranyi, G Wittert, M Le May, AS Pandey, S Vizel, R Labonte, Y Beaudry, C Fortin, A Bell, S Kouz, É St-Amour, I Bata, F St Maurice, R Chehayeb, C Constance, G Wong, A Hess, J Liutkus, P Poirier, I Teitelbaum, J Berlingieri, J Cha, M Hartleib, M Heffernan, D Twum-Barima, V Pandith, R Aronson, R Goldenberg, B Ajala, A Jain, S Ross, H Bajaj, H Khandwala, Z Yared, N Gupta, J Bédard, S Wharton, F Blouin, D Savard, D Shukla, J Cobos, G Godoy, L Perez, C Pincetti, V Saavedra Guajardo, P Varleta, C Conejeros, F Lanas, E Bayram Llamas, E Cardona Muñoz, R Garcia, J Garza Ruiz, G Llamas Esperon, E Lopez Rosas, G Melendez Mier, G Ramos, H Hart, D Scott, I Ternouth, J Benatar, J Elliott, R Cutfield, P Manning, M Williams, K Ferrier, R Scott, S Wilson, R Leikis, BK Nirmalaraj, E Krzyżagórska, P Miękus, M Bronisz, E Mirek-Bryniarska, K Łanda, A Stasiewski, T Żechowicz, D Zytkiewicz-Jaruga, J Korecki, M Ogórek, L Pawłowicz, M Piepiorka, J Skierkowska, A Stankiewicz, E Szyprowska, R Witek, A Bochenek, P Kończakowski, Ł Wojnowski, M Wujkowski, K Cymerman, R Korzeniak, P Mąder, B Mikłaszewicz, P Stachlewski, A Goch, W Pomiećko, M Skórski, L Romanowski, K Jusiak, E Laskowska-Derlaga, R Bijata-Bronisz, J Kaźmierczak, R Goldberg, D Henderson, E Korban, K Rohr, E Claxton, R Weiss, D Angiolillo, F Boccalandro, K Chu, E Thorn, P Randhawa, N Singh, G Bittar, T Guarnieri, S Saeed, S Sharma, M Shepard, W French, P Desai, R Bernstein, W Rogers, R Singal, R Schneider, J Shanes, S Ong, J Condit, S Donahoe, D Brill, D Einhorn, R Ebrahimi, A Labroo, R Graf, J Scott, J Hoekstra, P Jetty, G Luckasen, P O'Donnell, W Gonte, D Pomposini, M Quadrel, M Koren, D Schlager, E Schramm, D Singal, S Lupovitch, A Soni, P Seigel, J Roberts, J Soufer, S Reza, E Quinlan, T Moretto, B First, M Khan, S Chilka, H Colfer, A Teklinski, K Wallace-Wilding, H Ellison, D Muse, S Aronoff, A Higgins, S Patel, V Elinoff, A Karim, V Awasty, R Chuang, H Roseman, P Dugano-Daphnis, M Albert, K Sheikh, H Bays, S Kaster, M Goldstein, D Rubino, G Calatayud, H Snyder, T Williams, K Hershon, M Hagan, S Isserman, B Kahn, J Anderson, MP Gimness, A Raisinghani, M Christina, M Raikhel, E Gillespie, E Portnay, M Heiman, M Qureshi, J Lee, R Blonder, F Cucher, G Miller, D Kotlaba, G Cornett, J Beavins, C Augenbraun, S Reinhardt, A Bartkowiak, A Salacata, T Blevins, S Benjamin, J Diener, W George, B Barker, R Richwine, D Baldari, A Alfieri, A Barreto, L Zhang, R Shah, E Hendrix, V Subramaniyam, S Hurley, M Lillestol, M O'Donoghue, S Shayani, E Ryan, R Call, L Zemel, A Chang, A Kivitz, B Freyne, V Bland, K Shore, E Mostel, E Uzoaga, N Andrawis, N Gabra, A Ghitis, K Sabatino, D Browder, S Varma, S Smith, R Fink, GR Aycock, WD Doty, T Alfonso, S Eshaghian, R Karlsberg, S Zarich, C Landau, M McKenzie, R Krause, W Davis, T Haddad, S Voyce, C Alford, J LeDoux, D O'Dea, J Park, V Aroda, A Getaneh, B Graham, R Bhagwat, D Korn, G Ruoff, A Wiseman, I Lieber, J Fialkow, JM Gonzalez-Campoy, C Bayron, B Bertolet, J Lash, C Gerrish, D Robertson, J Rosenfeld, M Seidner, J Agaiby, J Silverfield, D Sugimoto, B Lubin, M Alhaddad, H Lui, G Lakin, S Chokshi, D Donovan, W Felten, S Minton, C Kimmelstiel, J Kuvin, C Still, W Byars, J Talano, V Desai, AJ Bradley, S Baker, M Chane, A Mercado, S Baron, B Harris, N Mayer, M Concha, K Carr, L Chaykin, J Willis, A Clay, E Fenstad, J Furda, P Peterson, M Chang, L Aronne, D Jones, R Prashad, M Benson, R Stegemoller, K Longshaw, J Saleh, W Jennings, R Detweiler, D Viswanath, R Patel, S Lederman, D Weinstein, R Korabathina, V Singh, J Rosen, R Estevez, P Levin, R McNeill, V Kalen, J Reed, R Ashley, L Herman, Y Tsai, D Kayne, A White, I Hussain, L Tami, K Cohen, J Robinson, D Fuchs-Ertman, G Platt, L Belardo, R Reddy, C Rosendorff, F Saba, S Powell, K Anderson, M Abidi, S Rezkalla, A Paraschos, J Wilson, M Moursi, A Shah, V Nadar, L Stonesifer, M Bialow, K Cannon, W Ellison, M Stedman, J Brown, W Harper, KJ Lucas, M DiGiovanna, H Rodbard, M Biscoveanu, C Davis, J Hall, R Littlefield, T Gorman, D Kereiakes, FM Chang, H Tatu, D Cheung, J Kaine, T Knutson, T Logemann, G Pueblitz, J Bianco, B Henson, M Neustel, M Gelernt, W Nelson, K Moriarty, G Lefebvre, K Maw, L Rink, P Behn, H Studdard, G Argoud, T O'Connor, P Krichmar, G Raad, J Pereles-Ortiz, C Sorli, A Cohen, K Pettis, B Cavanaugh, C Phillips, J Wahlen, D Radin, J Rider, E Kosinski, W Leimbach, A Odhav, J Hakas, A Tan, M Howell, D Wombolt, N Fishman, P Shah, P Wylie, C Arauz-Pacheco, A Cavale, A George, R Kroll, J Krantzler, N Tahirkheli, M Jabro, M Newell, P Mullen, N Gencheff, J Meli, K Vora, L Kotek, K Pyzdrowski, H Paez, J Moran, A Tannenbaum, K Deck, R Busch, L Levinson, M Azizad, J Whitaker, B Fox, C Huffman, M Ashraf, J Diogo, R Kushner, J Tallet, V Channamsetty, D Suh, M Atieh, J Navas, V Young, S Shaw, I Dor, B Duffy, P Rubin, D Lewis, W Kaye, R Benton, J Burbano, D Hotchkiss, A Magno, A Alberton, J Collins, O Alvarado, M Stich, S Mahal, J Liu, M Hong, J Dy, B Block, J Lamantia, J Pritchard, M Davis, S Srivastava, S Bilazarian, R Rosario, M McCartney, V Blumberg, R Rajan, E Martin, S Wright, C Brinson, J Johnston, M Graves, M Dominguez, W McKenzie, R Abadier, C Tran, R Castello, E Morawski, J White, F Morris, A Perez, P Trueba, M Sanchez, J Andersen, R Kastelic, J Khan, H Rodriguez, W Izquierdo, A Matias, L Essandoh, C Ince

Publikováno v: Lancet (London, England). 392(10161)

BACKGROUND: There is a direct relationship between bodyweight and risk of diabetes. Lorcaserin, a selective serotonin 2C receptor agonist that suppresses appetite, has been shown to facilitate sustained weight loss in obese or overweight patients. We

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a3a4e189e200fa6beb5d4585cfb676ca
https://pubmed.ncbi.nlm.nih.gov/30740430

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Effectiveness and Value of Integrating Behavioral Health Into Primary Care

Autor: Sarah J. Reed, Karen K. Shore, Jeffrey A. Tice

Publikováno v: JAMA internal medicine. 176(5)

Background Nearly 30%of adults with a physical health disorder also have one ormorebehavioralhealthconditions, suchasanxietydisorders,panic disorders, mood disorders, or substance use disorders.2 Despite theseconditionsbeing inextricably linked, clin

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8eddf783856fbe54e4ed9470dbbb8726
https://pubmed.ncbi.nlm.nih.gov/27064485