Challenges and Opportunities in IBD Clinical Trial Design

TY - JOUR

T1 - Challenges and Opportunities in IBD Clinical Trial Design

AU - International Organization for the Study of Inflammatory Bowel Diseases (IOIBD)

AU - Dubinsky, Marla C.

AU - Collins, Rory

AU - Abreu, Maria T.

AU - Jairath, Vipul

AU - Lewis, James D.

AU - Lindsay, James

AU - Merad, Miriam

AU - Ng, Siew

AU - Panaccione, Remo

AU - Panes, Julian

AU - Sands, Bruce

AU - Siegal, Corey A.

AU - Singh, Siddarth

AU - Vermeire, Severine

AU - Ahuja, Vineet

AU - Allez, Matthieu

AU - Ananthakrishnan, Ashwin

AU - Bemelman, Willem

AU - Braun, Jonathan

AU - Colombel, Jean Frederic

AU - Danese, Silvio

AU - D'Haens, Geert

AU - D'Hoore, André

AU - Dignass, Axel

AU - Dotan, Iris

AU - Gassul, Miguel Angel

AU - Griffiths, Anne

AU - Halfvarson, Jonas

AU - Hanauer, Stephen

AU - Kotze, Paulo

AU - Koutroubakis, Ioannis

AU - Loftus, Edward

AU - Louis, Edouard

AU - Magro, Fernando

AU - Mantzaris, Gerassimos

AU - Mary, Jean Yves

AU - McGovern, Dermot

AU - Munkholm, Pia

AU - O'Morain, Colm

AU - Panis, Yves

AU - Peyrin-Biroulet, Laurent

AU - Prantera, Cosimo

AU - Ran, Zhihua

AU - Siegmund, Britta

AU - Silverberg, Mark

AU - Stange, Eduard

AU - Targan, Stephan

AU - Tysk, Curt

AU - Travis, Simon

AU - Vatn, Morton

N1 - Funding Information: Funding This study was funded by the International Organization for the Study of Inflammatory Bowel Disease (IOIBD). IOIBD is supported by physician membership dues and corporate membership dues. IOIBD corporate members include AbbVie Inc, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Dr. Falk Pharma, EA Pharma, Eli Lilly, Ferring, Galapagos, Gilead, Gossamer Bio, Janssen Pharmaceutical, Nestlé Health Science, Pfizer, Roche, Takeda Pharmaceutical, and Tillotts Pharma. Funding Information: The IOIBD Challenges and Opportunities in IBD Clinical Trial Design Group represents expert speakers and panelists who participated in the meeting and who also served as authors in the development of the Meeting Summary. The speaker banner is as follows:, Maria T. Abreu, University of Miami;, Rory Collins, British Heart Foundation, University of Oxford (UK);, Marla C. Dubinsky, Icahn School of Medicine, New York;, Vipul Jairath, Western University Ontario;, James D. Lewis, Perelman School of Medicine, University of Pennsylvania;, James Lindsay, Barts Health NHS Trust, Royal London Hospital;, Miriam Merad, Icahn School of Medicine, New York;, Siew Ng, Chinese University of Hong Kong, Prince Wales Hospital;, Remo Panaccione, Cumming School of Medicine, University of Calgary;, Julian Panes, Clinic Barcelona, Hospital University;, Bruce Sands, Icahn School of Medicine, New York;, Corey A. Siegal, Dartmouth-Hitchcock Medical Center;, Siddarth Singh, UC San Diego Health; and, Severine Vermeire, KU Leuven. The physician members are as follows:, Vineet Ahuja, All India Institute of Medical Sciences;, Matthieu Allez, H?pital Saint-Louis?Paris;, Ashwin Ananthakrishnan, Harvard Medical School/Harvard School of Dental Medicine;, Willem Bemelman, Amsterdam UMC;, Jonathan Braun, IRIBI, Cedars Sinai Medical Center;, Jean-Frederic Colombel, Icahn School of Medicine at Mount Sinai NY;, Silvio Danese, Humanitas Research Hospital?Milano;, Geert D'Haens, Amsterdam UMC;, Andr? D'Hoore, UZ Leuven;, Axel Dignass, Agaplesion Markus Hospital;, Iris Dotan, Rabin Medical Center & the Sackler Faculty of Medicine?Tel Aviv;, Miguel Angel Gassul, IGTP Germans Trias i Pujol Foundation?Spain;, Anne Griffiths, SickKids Hospital Toronto;, Jonas Halfvarson, ?rebro University Hospital?Sweden;, Stephen Hanauer, Northwestern University;, Paulo Kotze, Cajuru University Hospital of the Catholic University?Brazil;, Ioannis Koutroubakis, University Hospital Heraklion?Greece;, Edward Loftus, Mayo Clinic;, Edouard Louis, University Hospital CHU Liege;, Fernando Magro, Instituto de Farmacologia Porto;, Gerassimos Mantzaris, Evangilismos Hospital Athens;, Jean-Yves Mary, INSERM Hospital Saint-Louis;, Dermot McGovern, Cedars-Sinai Medical Center;, Pia Munkholm, Danish Center for eHealth & Epidemiology (DEEP);, Colm O'Morain, Beacon Consultants Clinic Dublin;, Yves Panis, Beaujon Hospital;, Laurent Peyrin-Biroulet, CHU de Nancy;, Cosimo Prantera, Ospedale San Camilo-Forlanini?Rome;, Zhihua Ran, Shanghai IBD Research Center;, Britta Siegmund, Charit? - Universit?tsmedizin Berlin;, Mark Silverberg, Mount Sinai Hospital Toronto;, Eduard Stange, Robert-Bosch Krankenhaus, Stuttgart;, Stephan Targan, Cedars-Sinai Medical Center;, Curt Tysk, ?rebro University Hospital?Sweden;, Simon Travis, Oxford University Hospital;, Morton Vatn, University of Oslo; and, Yesus Yamamoto-Furusho, National Institute of Medical Sciences and Nutrition?Mexico. Additional meeting participants are as follows:, Janske Aarts, Pfizer Inc.;, Brihad Abhyankar, Theravance Biopharma Ireland Ltd.;, Harris Ahmad, Bristol-Myers Squibb;, Richard Aranda, Gossamer BIO;, Vipin Arora, Eli Lilly & Company;, Jalil Benjacoub, Nestle Health Science;, Sofie Berg, AbbVie Inc.;, Robin Besuyen, Galapagos;, Daniela Bojic, F. Hoffmann-La Roche AG;, Valerio Carriero, AbbVie Inc.;, Fabio Cataldi, Arena Pharmaceuticals Inc.;, Laurence D'Agay, Celgene Int.;, Silvia Delgado-Aros, Boehringer-Ingelheim;, Paul Giannasca, Nestle Health Science;, Kavitha Goyal, Janssen Pharmaceuticals;, Roland Greinwald, Dr. Falk Pharma GmbH;, Savion Gropper, Boehringer-Ingelheim;, Shunsuke Kageyama, EA Pharma Co. Ltd.;, Rapha?l Laoun, Tillotts Pharma AG;, Barrett Levesque, Gossamer BIO;, Trevor Lissoos, Eli Lilly & Company;, Irene Modesto, Pfizer Inc.;, Ralf Mohrbacher, Dr. Falk Pharma GmbH;, Ralph Mueller, Dr. Falk Pharma GmbH;, April Naegeli, Eli Lilly & Company;, Snehal Naik, Arena Pharmaceuticals Inc.;, Deanne Nguyen, Theravance Biopharma Ireland Ltd.;, Wojciech Niezychowski, Pfizer Inc.;, Caitriona O'Brien, Gilead;, Irina Odnoletkova, Galapagos;, Alessandra Oortwijn, Galapagos;, Kun KT Park, F. Hoffmann-La Roche AG;, Waldemar Radziszewski, Amgen; Camilla Rowan, Janssen Pharmaceuticals;, Leonardo Salese, Pfizer Inc.; Johannes Spleiss, Tillotts Pharma AG;, Andrea Stancati, Takeda; Amanda Tatro, F. Hoffmann-La Roche AG;, Jennifer Thompson, Boehringer-Ingelheim; Robert Hofmann, Tillotts Pharma AG;, Javier Zambrano, AbbVie Inc.;, Wen Zhou, AbbVie Inc.; and, Ellen Zigmont, Gossamer BIO. Funding This study was funded by the International Organization for the Study of Inflammatory Bowel Disease (IOIBD). IOIBD is supported by physician membership dues and corporate membership dues. IOIBD corporate members include AbbVie Inc, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Dr. Falk Pharma, EA Pharma, Eli Lilly, Ferring, Galapagos, Gilead, Gossamer Bio, Janssen Pharmaceutical, Nestl? Health Science, Pfizer, Roche, Takeda Pharmaceutical, and Tillotts Pharma.

PY - 2021/8

Y1 - 2021/8

KW - Clinical Trials

KW - Crohn's Disease

KW - Inflammatory Bowel Disease

KW - Ulcerative Colitis

UR - http://www.scopus.com/inward/record.url?scp=85111072778&partnerID=8YFLogxK

U2 - 10.1053/j.gastro.2021.03.065

DO - 10.1053/j.gastro.2021.03.065

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C2 - 33864796

AN - SCOPUS:85111072778

SN - 0016-5085

VL - 161

SP - 400

EP - 404

JO - Gastroenterology

JF - Gastroenterology

IS - 2

ER -