Experience

Adelphi Values has an experienced global team of qualitative researchers, health economists, statisticians, creative scientists, clinicians and strategists with industry experience, who truly understand the need to develop evidence and communicate value throughout the product lifecycle.

Below is a selection of our projects, presented according to therapeutic or strategic/methodological area. It is not exhaustive, and we would be happy to provide further information on request.

College voor zorgverzekeringen (CVZ – Netherlands)

  • Cost-effectiveness assessment for drug to be listed on the hospital ‘expensive drug list’
  • Cost-effectiveness assessment for an orphan drug
  • Diabetes (type 1)
  • Diaper dermatitis complicated by candidiasis in infants
  • Heart failure
  • Herpes zoster vaccine
  • HPV vaccine
  • Metabolic syndrome
  • Metastatic soft-tissue sarcoma

Colorectal cancer

  • Project management of a mixed treatment analysis on colorectal cancer
  • Update to a payer value slide deck in metastatic colorectal cancer
  • Value-based model in colorectal cancer
  • Payer communications strategy and tools in colorectal cancer
  • Reimbursement dossiers in subgroups of colorectal cancer
  • Mini literature review in metastatic colorectal cancer
  • Literature review and payer communication tools in metastatic colorectal cancer
  • Translation to support development of a value dossier and budget impact model in capsule endoscopy for colonoscopy
  • Global model update and country adaptations for a multi-indication value-based pricing (VBP) model on colorectal cancer
  • PRO assessment on the neurotoxicity of a treatment for advanced colorectal cancer
  • Clinical trial analyses to support HRQoL in recurrent and metastatic microsatellite instability high colorectal cancer
  • White Paper on continuous infusion in colorectal cancer
  • Development of cost arguments and brochure development in colorectal cancer
  • Network meta-analysis on the efficacy of treatment for metastatic colorectal cancer
  • Recommendations on the economic impact of a treatment for metastatic colorectal cancer
  • Network meta-analysis of a treatment versus other biologics for metastatic colorectal cancer in 1st line, 2nd line and multiple line settings
  • Web-based survey to understand patient-preference and satisfaction in advanced colorectal cancer

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

Contraception

  • PRO endpoint review in contraceptives
  • Manuscript publication on a monthly contraceptive device
  • Development of a PRO strategy in oral contraceptives and gynaecological therapies
  • Modification, development and validation of an existing tool in order to explore satisfaction and tolerability for an intrauterine device (IUD) versus oral contraceptives
  • Modification of the EVAPIL-R in order to explore tolerability for an intrauterine system (IUS) versus an implantable contraceptive
  • Linguistic validation of the EVAPIL-R questionnaire on tolerability of oral contraceptives
  • Expert panel meeting on an oral contraceptive

Cough and cold

  • Literature review on cough and cold over-the-counter medications
  • Strategy meeting on colds and coughs with the Consumer Healthcare Products Association
  • Communication support to develop a PRO instrument to measure multiple cold symptoms in children
  • Research to support the development of a PRO strategy for use in paediatric cough and cold
  • Development and validation of an ePRO instrument to assess symptoms associated with paediatric cold
  • Validation of a 3 item composite measure to assess the symptoms of chronic rhinisitus
  • Consulting for an FDA meeting and requirements regarding the Total Sinus Symptom Score (TSSS) as a primary endpoint in chronic rhinisitus
  • Cognitive debrief of cold symptom PRO questions in paediatric patients
  • Development and content validity testing of PRO questions developed to measure additional paediatric cold symptoms
  • Pilot testing and validation of a PRO instrument to measure multiple cold symptoms in children

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

Cushing’s disease

  • Input into PRO analyses for Cushing’s disease
  • Consultancy support for a clinical trial statistical analysis plan (SAP) in Cushing’s disease
  • Publication support and consultancy associated with patient-reported outcomes data for a trial in patients with Cushing’s disease
  • Consultancy and support associated with proposed analysis, communication and regulatory submission of patient-reported outcomes data for a trial in patients with Cushing’s disease

Cystic fibrosis

  • FDA PRO consulting for cystic fibrosis
  • Gap analysis and strategic recommendations for the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
  • Model of cystic fibrosis disease progression

Dementia

  • Linguistic validation of the Neuropsychiatric Inventory (NPI) in dementia
  • Structured literature review in lewy body dementia
  • Clinical trial synopsis consulting for a phase III clinical program in dementia

Dengue disease

  • Finalization and validation of a PRO instrument for measurement of burden in Dengue disease