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.

Fragile X syndrome

  • Consultancy support for clinical trials in Fragile X syndrome
  • Literature review to develop a conceptual model for individuals with Fragile X syndrome (aged 5-12 years old)

Fungal infections

  • Strategic review of the key clinical and health outcomes evidence available/planned for an antifungal medication in order to perform a message audit for each key economic value message (including identification of evidence gaps)
  • Global value dossier and value story for a product in fungal infections
  • Simultaneous development and regulatory documentation of two PRO questionnaires to assess the signs and symptoms of interdigital tinea pedis and rosacea
  • Cost-effectiveness analysis of an antifungal drug in Sweden
  • Adaptation of a model on an antifungal medication for the USA and UK
  • Simultaneous development and regulatory documentation of two PRO questionnaires to assess the signs and symptoms of interdigital tinea pedis and rosacea

Gastric cancer

  • Global value dossier for treatment in gastric cancer
  • Development of a cost-calculator for a biosimilar for gastric cancer
  • Review of a SMC submission for a chemotherapy drug for advanced gastric cancer
  • Burden of disease deck, payer value dossier deck and frequently asked questions deck in gastric cancer
  • Payer value deck in 1st line gastric cancer
  • Response to payer questions in 1st line gastric cancer
  • Literature and PRO strategy for gastric oesophageal cancer
  • Literature review and development of a PRO strategy for gastric cancer
  • Statistical analyses to support HRQoL in gastric cancer, and estimation of EQ-5D utilities for an Asian population in a trial based on existing data and non-Asian trial utility data
  • Advisory board attendance and presentation for utilities in gastric cancer and illustrative summary analyses
  • Utilities analyses to support economic modelling in gastric cancer

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

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

Gaucher’s disease

  • Payer research to understand evidence requirements for reimbursement in Gaucher’s disease
  • HTA recommendations analysis in Gaucher’s disease
  • Development and validation of a questionnaire in Gaucher’s disease

Glaucoma

  • Two mini value dossiers in glaucoma
  • Patient interviews on glaucoma treatment characteristics and outcomes: Unmet patient needs & value drivers
  • Development of a utility instrument in glaucoma

Glioblastoma

  • Development of a global value dossier in the treatment of glioblastoma
  • AMCP dossier in glioblastoma multiforme
  • Early global value dossier in newly diagnosed glioblastoma
  • Clinical trial analyses to support health-related quality of life (HRQoL) in glioblastoma
  • Review of instruments for a glioblastoma trial and recommendation of a strategy
  • PRO dossier on glioblastomas for the EMA
  • Literature review on overall survival and progression-free survival in glioblastomas
  • Poster on the association of HRQoL and NCF with progression-free survival (PFS) and PD in glioblastoma
  • Indirect comparison of two treatments in 2nd line glioblastoma
  • Training slide deck for COAs in glioblastoma

Glucose transporter type 1 deficiency syndrome

  • Qualitative research to explore and support the assessment of the patient experience and impact of functioning of movement disorders in glucose transporter type 1 deficiency syndrome, and literature review in absence seizures