期刊
GASTROENTEROLOGY
卷 143, 期 6, 页码 1461-1469出版社
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.gastro.2012.09.031
关键词
Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; Trial Design; Clinical Trials
资金
- Abbott Laboratories
- ActoGeniX
- Centocor
- Cosmo
- enGene
- Ferring Pharmaceuticals
- GlaxoSmithKline
- Janssen Biologics
- Millennium Pharmaceuticals
- MSD
- Novo Nordisk
- PDL BioPharma
- Pfizer
- SetPoint
- Shire
- Takeda
- Teva
- UCB
- Given Imaging
- Falk Pharma
- PhotoPill
- Tillotts Pharma AG
- Tramedico
- Norgine
- Vifor Pharma
- Synta Pharmaceuticals
- Merck
- Elan/Biogen
- Janssen-Ortho
- Protein Design Labs
- Isis Pharmaceuticals
- Teva Pharmaceuticals
- Santarus
- Schering-Plough
- Bristol-Myers Squibb
- Celgene
- CombinatoRx
- UCB Pharma
- Napo Pharma
- Procter Gamble
- Osiris
- Berlex
- AstraZeneca
- Gene Logic
- Cerimon Pharmaceuticals
- Tioga Pharmaceuticals
- Serono
- Genentech
- Unity Pharmaceuticals
- Albireo Pharma
- Salix Pharmaceuticals
- Ore Pharmaceuticals
- Prometheus Therapeutics and Diagnostics
- Athersys
- Alba Therapeutics
- Axcan
- Funxional Therapeutics
- Gilead Sciences
- Nektar
- Wyeth
- Zealand Pharma
- Otsuka
- Boehringer Ingelheim
- Novartis
- Schering Canada
- Lesaffre
- Giuliani SPA
- Danisco
- Ocera Therapeutics
- Danone
- Roquette Pharma
- Mapi-Naxis
- Disphar
- AGI Therapeutics
- Albireo
- Alfa Wasserman
- Amgen
- AM-Pharma BV
- Anaphore
- Astellas
- Atlantic Healthcare
- Aptalis
- BioBalance
- Celek Pharmaceuticals
- Cellerix SL
- ChemoCentryx
- CoMentis
- Cosmo Technologies
- Coronado Biosciences
- Cytokine PharmaSciences
- Eagle Pharmaceuticals
- Eli Lilly
- EnteroMedics
- Exagen Diagnostics
- Flexion Therapeutics
- Genzyme
- Human Genome Sciences
- Ironwood Pharmaceuticals
- KaloBios Pharmaceuticals
- Lexicon Pharmaceuticals
- Lycera
- Meda Pharmaceuticals
- Merck Research Laboratories
- Merck Serono
- Nisshin Kyorin Pharmaceuticals
- NPS Pharmaceuticals
- Optimer Pharmaceuticals
- Orexigen Therapeutics
- Prometheus Laboratories
- ProtAb
- PurGenesis Technologies
- Relypsa
- Roche
- Salient Pharmaceuticals
- Shire Pharmaceuticals
- Sigmoid Pharma
- Sirtris Pharmaceuticals
- SLA Pharma UK
- Targacept
- Therakos
- TxCell SA
- Viamet Pharmaceuticals
- Vascular Biogenics
- Warner Chilcott UK
- Janssen
- Millennium/Takeda
- Genentech/Hoffman-La Roche
- Neovacs
- Merck/Serono
- Robarts
- Vifor
- Merck Sharp Dohme
- Alba
- VSL
Treatment of inflammatory bowel disease has greatly improved with the development of targeted, monoclonal antibody-based therapies. Tumor necrosis factor antagonists are frequently used to treat patients with Crohn's disease or ulcerative colitis, but they have side effects and their efficacy often decreases with use. New, more effective drugs are therefore needed and in development. However, many agents that appeared to be promising in preclinical studies have failed to show efficacy in clinical trials. We discuss possible reasons for the failures of these reagents in trials, which include the high rate of response to placebo, an inadequate range of doses, inappropriate timing of end point measurements, the changing therapeutic environment, and the competitive trial system. We also review regulatory guidelines for end points and trial design and recommend ways to improve trials.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据