Gastrointestinal diseases

Other gastrointestinal experience

  • Development of a global value dossier and budget impact model for capsule endoscopy for colonoscopy
  • Global value dossier for a therapy device in refractory ascites
  • Biosimilar payer communications in gastroenterology
  • Health economics support package in gastroenterology
  • Value proposition on a treatment for heartburn and indigestion
  • Cognitive debriefing and content validation of the diarrhoea symptom assessment measure
  • Cognitive debriefing of the Gastrointestinal Symptom Rating Scale Diarrhoea Domain in patients with Fabry’s disease
  • Support with interviews in paediatric vomiting
  • Managing patients with stoma: Adaptation of a Quality of Life Index (QLI) questionnaire to current needs for colostomy patients
  • Consultation and conduction of a discussion panel at the European Council of Enterostomal Therapy conference
  • Development of a manuscript based on modification of an ostomy study
  • Language validation interview for an ascites impact questionnaire
  • General consulting agreement in gastrointestinal assessments
  • Training work on post-operative nausea and vomiting
  • Strategic consultancy in gastrointestinal symptoms of Fabry’s disease
  • HEOR consulting services including clinical outcomes and regulatory approach

Clostridium difficile

  • Pre-budget impact analysis and economic advice for personalized medicine: approaches to diagnose and control clostridium difficile infections

Short bowel syndrome

  • Initial market access evidence assessment for a new orphan drug for short bowel syndrome
  • UK patient disease journey in short bowel syndrome

Rotavirus

  • Payer material development for vaccines in rotavirus gastroenteritis (RVGE)
  • e-v@luate platform on a vaccine for rotavirus

Eosinophilic gastroenteritis

  • Evaluation of COA tools in eosinophilic gastroenteritis (EGE) and eosinophilic gastritis (EG) with additional longitudinal data collection

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

Constipation

  • Market access consultancy in the treatment of chronic idiopathic constipation
  • Cognitive debriefing interviews for a paediatric constipation symptom diary
  • Development of a PRO strategy for paediatric chronic constipation
  • Development of PRO instruments assessing symptoms and health-related quality of life for paediatric patients with chronic constipation
  • Development of a primary endpoint to assess quality of life in paediatric constipation
  • Providing support in the design and set up of a paediatric functional constipation dose ranging study, updating the eCOA and incorporation of the eCOA into the trial, and support in performing psychometric validation using the trial data
  • Face and content validation of an e-diary to assess opioid-induced constipation and other gastrointestinal side effects in chronic non-cancer pain
  • Planning and execution of an advisory board to obtain feedback on the PRO strategy and plans for the phase III program for a treatment for opioid-induced constipation
  • Patient interviews to assess content validity of an instrument for use in opioid-induced constipation
  • Cognitive debriefing of 7-day recall period for the Patient Assessment of Constipation, Quality of Life Questionnaire (PAC-QOL) and Patient Assessment of Constipation Symptoms (PAC-SYM) in opioid-induced constipation
  • PAC-SYM and analysis of a skin patch containing an opioid pain medication
  • Review of patient diaries and PRO questionnaires for evaluating constipation in opioid-treated non-cancer pain
  • In-depth interviews, instrument development and cognitive debriefing related to measurement of opioid-induced constipation
  • Validation of a patient e-diary to assess opioid-induced constipation
  • Consolidation of results on the development of a bowel function diary for opioid-induced constipation
  • Endpoint model, conceptual framework, cognitive debriefing interview, saturation point and report on opioid-induced constipation
  • Cognitive debriefing of a PRO measure of paediatric chronic constipation
  • Long term safety study and participation interviews in chronic constipation
  • Consultation on a project on chronic constipation
  • Manuscript based on a literature review in paediatric constipation
  • Literature review on chronic constipation
  • FDA meeting on chronic constipation
  • Interviews with clinicians to understand diagnoses of paediatric chronic constipation

Crohn’s disease

  • Early global value dossiers for a new monoclonal antibody in Crohn’s disease
  • Literature review and recommendations for Crohn’s disease
  • Payer objection/question responses in Crohn’s disease
  • White paper on PROs in Crohn’s disease
  • FDA briefing document on Crohn’s disease
  • Advisory board on a treatment for Crohn’s disease
  • Development and implementation of a plan to deliver economic and outcomes evidence to support commercialisation of a treatment for Crohn’s disease in key markets
  • US database analysis to support a pharmacoeconomic model in Crohn’s disease in the US
  • PRO review in Crohn’s disease
  • PRO gap analysis and initial PRO dossier development in Crohn’s disease
  • Support in development and analyses of a patient support programme in Crohn’s disease

Ulcerative colitis

  • Payer objection/question responses in ulcerative colitis
  • Manuscript reporting the literature review and qualitative research project with ulcerative colitis subjects
  • Workshop and FAQ development in immunology in ulcerative colitis
  • Development of a payer value deck in immunology in ulcerative colitis
  • PRO gap analysis and initial PRO dossier development in ulcerative colitis
  • Support in development and analyses of a patient support programme in ulcerative colitis

Post-operative ileus

  • Literature review of the management of post-operative ileus in Europe
  • Analysis of the burden of illness of post-operative ileus in 4 European countries
  • Analysis of post-operative ileus in a complicated population using country-specific databases

Eosinophilic esophagitis

  • Development and validation of a PRO measure in paediatric patients with eosinophilic esophagitis
  • Qualitative interviews to develop a symptom measure in adult patients with eosinophilic esophagitis
  • Re-analysis of qualitative data and cognitive debriefing interviews to create a symptom measure in esonophilic esophagitis
  • Analysis of a field trial on eosinophilic esophagitis
  • Cognitive debriefing and modification of the Eosinophilic Esophagitis Activity Index (EEsAI)
  • Modification of the Eosinophilic Esophagitis Activity Index (EEsAI)

Gastroparesis

  • Testing of the validity of gastroparesis symptom questions
  • Sub group analysis of gastroparesis patients interviewed in exploratory phase, Rasch analysis and PCA on a 5 item scale
  • Phase III statistical analysis plan and regulatory consulting on the gastroparesis symptom assessment (GSA) for submission
  • Review of a protocol amendment for a phase II gastroparesis study which includes the Care-giver Strain Index (CGSI) as a primary endpoint
  • Review of protocol on a phase II study of subjects with severe gastroparesis due to diabetes mellitus
  • Cognitive debriefing of a symptom measure of gastroparesis in diabetics and standalone validation study

Gastroesophageal reflux disease and gastric reflux

  • Literature review of COA endpoints in paediatric gastric reflux
  • Activities to confirm the cross-cultural validity of a conceptual model in paediatric gastro-oesophageal reflux disease (GERD)
  • Manuscript on the simultaneous development of the Paediatric GERD Caregiver Impact Questionnaire (in gastroesophageal reflux disease) in American English and American Spanish
  • Cognitive debriefings in patients with GERD
  • De-identification of transcripts in GERD
  • Content validity and pilot testing of the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-DD) in the UK and five European markets

Dyspepsia

  • Payer value proposition in dyspepsia
  • Interviews in dyspepsia
  • Development of a briefing packet for a FDA Type C meeting for a primary endpoint in functional dyspepsia
  • Linguistic validation of the Severity of Dyspepsia Assessment (SODA) and Pain Treatment Satisfaction Scale (PTSS) questionnaires into UK English
  • Development of a PRO to assess the symptoms of functional dyspepsia for the purposes of labelling
  • Quantitative research in functional dyspepsia