Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease.
Jurij HanželVipul JairathPeter De CruzLeonardo GuizzettiLisa M ShackeltonPeter BossuytMarjolijn DuijvesteinParambir S DulaiJohannes GrossmannRobert P HirtenReena KhannaJulian PanesLaurent Peyrin-BirouletMiguel RegueiroDavid T RubinSiddharth SinghRyan W StidhamWilliam J SandbornBrian G FeaganGeert R D'HaensChristopher MaPublished in: Inflammatory bowel diseases (2021)
A framework for regulatory trial design for the prevention of postoperative CD recurrence and endoscopic assessment of disease activity has been developed. Research to empirically validate end points for these trials is needed.
Keyphrases
- disease activity
- clinical trial
- rheumatoid arthritis
- systemic lupus erythematosus
- ultrasound guided
- patients undergoing
- rheumatoid arthritis patients
- study protocol
- ankylosing spondylitis
- phase ii
- phase iii
- juvenile idiopathic arthritis
- transcription factor
- open label
- clinical practice
- double blind
- endoscopic submucosal dissection
- clinical evaluation