Differences Between the 2016 and 2022 Food and Drug Administration Guidance—Implications for Design and Interpretation of ClinicalTrials in Ulcerative Colitis

Keyphrases

• Ulcerative Colitis 100%
• Colonoscopy 100%
• Sigmoidoscopy 66%
• Adverse Events 33%
• Washout Period 33%
• Corticosteroids 33%
• Clinical Trials 33%
• Histologic 33%
• Clinical Trial Design 33%
• High Burden 33%
• Active Disease 33%
• Non-associated 33%
• Drug Development 33%
• Colon 33%
• Scar 33%
• Disease Activity 33%
• Trial Results 33%
• Welcome 33%
• Mucosa 33%
• Implications for Future 33%
• Trial Participants 33%
• Normal Appearance 33%
• Flexible Sigmoidoscopy 33%
• Bridging Therapy 33%
• Mayo Endoscopic Subscore 33%
• Mucosal Healing 33%
• Patient Exposure 33%
• Bowel Preparation 33%
• Pseudopolyps 33%
• Preparation Cost 33%
• Endoscopic Sign 33%

Medicine and Dentistry

• Ulcerative Colitis 100%
• Colonoscopy 100%
• Sigmoidoscopy 100%
• Diseases 66%
• Health Care Cost 33%
• Adverse Event 33%
• Clinical Trial 33%
• Disease Activity 33%
• Scar Formation 33%
• Colon 33%
• Clinical Trial Design 33%
• Mucosa 33%
• Intestine Preparation 33%
• Pseudopolyps 33%

Pharmacology, Toxicology and Pharmaceutical Science

• Ulcerative Colitis 100%
• Diseases 100%
• Adverse Event 50%
• Drug Development 50%
• Clinical Trial 50%
• Disease Activity 50%
• Scar Formation 50%
• Clinical Trial Design 50%