Irritable bowel syndrome

  • Literature review of PROs and endpoints of pain in irritable bowel syndrome (IBS)
  • Literature review and manuscript on IBS
  • Patient interviews and qualitative work on IBS
  • Analysis of focus group data in IBS
  • Productivity workshop in IBS
  • Focus groups in IBS
  • Consulting for PROs for a treatment used in IBS
  • Prospective outcomes study in IBS
  • PRO strategy in generalized anxiety disorder with functional digestive disorders / IBS
  • Mixed methods analysis of cognitive debriefing data in irritable bowel syndrome with constipation or chronic constipation (IBS-C/CC)
  • PRO dossier in IBS-C
  • Independent analysis, evidence saturation and report on 30 interviews in IBS-C
  • Development of a PRO strategy for paediatric IBS-C
  • Literature review in IBS-C
  • Manuscript based on the findings of the exit interview study of patients taking a treatment for IBS-C within a long term safety study
  • Exploratory analysis of PRO data to support the interpretation of change on IBS-C abdominal symptom endpoints
  • Development of PRO instruments assessing symptoms and health related quality of life for paediatric patients with IBS-C
  • Testing and cognitive debriefing interviews for a diary in paediatric symptoms of IBS-C/CC
  • Network meta-analysis of treatments for IBC-C/CC
  • Conference poster and debriefing of paediatric IBS-C
  • Cognitive debriefing of a PRO measure of IBS-C symptoms
  • Long term safety study and participation interviews in IBS-C
  • Consultation on a project on IBS-C
  • FDA meeting on IBS-C
  • Interviews with clinicians to understand diagnoses of paediatric IBS-C
  • Development and validation of a primary endpoint to support an indication in irritable bowel syndrome with diarrhoea (IBS-D)
  • Psychometric validation of a newly developed PRO for IBS-D
  • Analysis of qualitative data on IBS-D from focus groups
  • Psychometric validation for a newly developed PRO in IBS-D
  • Development of a PRO measurement dossier on IBS-D for submission to the FDA
  • Development of a PRO instrument assessing symptoms in paediatric patients with IBS-D
  • Assistance with preparations for an FDA type C meeting on IBS-D
  • Development and validation of a primary endpoint for an FDA submission in IBS-D
  • Selection of PROs for IBS-D, regulatory strategy and support
  • Phase II data analysis: Interim and final psychometric testing in IBS-D
  • Manuscript on IBS-C and IBS-D