Endpoints, reliability, and meaningful changes in clinical trials for children with irritable bowel syndrome. The Rome foundation pediatric subcommittee on clinical trials

M Saps¹, J V Lavigne², M A van Tilburg^{3

4}, A Miranda⁵, M A Benninga⁶, J A Taminiau⁷, C Di Lorenzo⁸

Affiliations

¹ Gastroenterology, University of Miami School of Medicine, Miami, USA.
² Child and Adolescent Psychiatry, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, USA.
³ Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, USA.
⁴ Department of Medicine, Campbell University College of Pharmacy and Health Sciences, School of Pharmacy & Health Sciences, University of Washington School of Public Health, School of Social Work, USA.
⁵ Medical College of Wisconsin, Peditarics, WI, USA.
⁶ Emma Children's Hospital/Academic Medical Centre, Pediatric Gastroenterology, Amsterdam, The Netherlands.
⁷ European Medical Agency, UK.
⁸ Division of Pediatric Gastroenterology Nationwide, Nationwide Children's Hospital, Columbus, USA.

Comment

M Saps et al. Neurogastroenterol Motil. 2018 May.

. 2018 May;30(5):e13308.

doi: 10.1111/nmo.13308.

M Saps¹, J V Lavigne², M A van Tilburg^{3

4}, A Miranda⁵, M A Benninga⁶, J A Taminiau⁷, C Di Lorenzo⁸

¹ Gastroenterology, University of Miami School of Medicine, Miami, USA.
² Child and Adolescent Psychiatry, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, USA.
³ Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, USA.
⁴ Department of Medicine, Campbell University College of Pharmacy and Health Sciences, School of Pharmacy & Health Sciences, University of Washington School of Public Health, School of Social Work, USA.
⁵ Medical College of Wisconsin, Peditarics, WI, USA.
⁶ Emma Children's Hospital/Academic Medical Centre, Pediatric Gastroenterology, Amsterdam, The Netherlands.
⁷ European Medical Agency, UK.
⁸ Division of Pediatric Gastroenterology Nationwide, Nationwide Children's Hospital, Columbus, USA.

No abstract available

Comment on

Statistical considerations about the design and endpoints of randomized clinical trials for children with irritable bowel syndrome.
Collignon O, Pétavy F. Collignon O, et al. Neurogastroenterol Motil. 2018 May;30(5):e13266. doi: 10.1111/nmo.13266. Neurogastroenterol Motil. 2018. PMID: 29700959 No abstract available.