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.

Down’s syndrome

  • Development of a COA strategy for Down’s syndrome in adults and children
  • Clinical meaningfulness of scores on the Vineland Adaptive Behaviour Scale (VABS-II), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Clinician Global Impression (CGI) in Down’s syndrome
  • Strategic literature review to identify COA instruments to assess the concept of independence in Down’s syndrome
  • Qualitative interviews and development of a COA strategy for Down’s syndrome in adults and children
  • Subgroup analysis by chronological age of individuals with Down’s syndrome

Dry eye

  • Healthcare resource costing study for dry eye disease in the UK
  • Development of a user manual on the Impact of Dry Eye in Everyday Life (IDEEL) using FDA guidelines
  • Revision of a manuscript on an IDEEL questionnaire for submission
  • Poster documenting development of the IDEEL
  • Consultation on composite endpoints for dry eye
  • Development of PRO for dry eye
  • Validation of a PRO for dry eye
  • Topline literature review to confirm information relating to three COAs for dry eye

Duchenne muscular dystrophy

  • Gap analysis of clinical outcome assessments and natural history of duchenne muscular dystrophy
  • Qualitative interviews with patients, caregivers and clinicians to define a clinician global impression of change item for duchenne muscular dystrophy

Duchenne muscular dystrophy

  • Gap analysis of clinical outcome assessments and natural history of duchenne muscular dystrophy
  • Qualitative interviews with patients, caregivers and clinicians to define a clinician global impression of change item for duchenne muscular dystrophy

Dyslipidaemia

  • Development of a manuscript from an existing report detailing an analysis already performed using an existing economic model in dyslipidemia

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

Ear infections and acute otitis media

  • Diary of a caregiver validation for ear infection using the standard methodology
  • Training and manuscripts on the acute otitis media caregiver diary
  • Quality of life impact of otitis media and associated productivity loss in Malaysia and South Korea

Economic models

We have extensive experience in modelling across a wide range of indications – our model experience includes budget impact models, cost effectiveness models, scenario models, cost calculator models, value-based pricing models, cost offset models, and cost utility models. Our experience is vast in this area and models have been developed for a large number of countries and with adaptations for different markets. We have developed models and model adaptations throughout Europe (including the EU5, eastern Europe and Scandinavia), on a Global scale, and for the US, Canada, Japan, Australia, Mexico and Brazil.

  • Acromegaly
  • Acute bacterial skin and skin structure infections (ABSSSI)
  • Allergies
  • Alzheimer’s disease
  • Anaemia
  • Anaesthesiology
  • Ankylosing spondylitis
  • Asthma
  • Benign prostatic hyperplasia
  • Bladder cancer
  • Breakthrough cancer pain
  • Breast cancer
  • Cardiometabolic risk
  • Chronic obstructive pulmonary disease (COPD)
  • Clostridium difficile infections
  • Colonoscopy
  • Colorectal cancer
  • Crohn’s disease
  • Diabetes (type 1 and 2)
  • Diabetic macular edema
  • Dyslipidaemia
  • Epilepsy
  • Esophogeal cancer
  • Gastric cancer
  • Head and neck cancer
  • Hepatitis C
  • HIV
  • Hormone replacement therapy
  • HPV
  • Human cord graft
  • Hypertension
  • Infection prevention
  • Infertility
  • Inflammatory bowel disease
  • Influenza
  • Leukaemia
  • Lung cancer (small cell and non-small cell)
  • Lymphomas
  • Melanoma
  • Mesothelioma
  • Multiple myeloma
  • Neuroendocrine tumours
  • Neuromuscular block
  • Osteoarthritis
  • Ovarian cancer
  • Pain
  • Parkinson’s disease
  • Phenylketonuria
  • Pneumococcal disease
  • Post-herpetic neuralgia
  • Psoriasis
  • Psoriatic arthritis
  • Renal cell carcinoma
  • Rheumatoid arthritis
  • Surgery and post-operative pain

Eczema

  • Literature review to identify the chronic hand eczema population in the US
  • Regulatory support in chronic hand eczema
  • Development of a manuscript to communicate the patient experience of chronic hand eczema
  • Two abstracts to communicate the development of a conceptual model in chronic hand eczema

Emphysema

  • General consultancy on economics, quality of life and reimbursement in lung volume reduction surgery in emphysema

Endometriosis

  • Validation of ePRO endpoints and a regulatory dossier to support claims in endometriosis
  • Qualitative research in Europe and validation of ePRO endpoints to support product labelling claims in endometriosis
  • Development and validation of ePRO endpoints for use in endometriosis
  • Psychometric validation and communications for newly developed PROs in endometriosis
  • PRO instrument development in endometriosis
  • Manuscript on PRO development and validation in endometriosis
  • Endpoint validation and finalisation in endometriosis
  • Review of a revision of a psychometric validation report on endometriosis and in-person attendance at FDA meeting
  • Endometriosis symptom diary and impact scale communications strategy
  • Exploration of instrument scoring (following EMA CHMP advice), psychometric evaluation using data from clinical studies and development of instrument user manuals in endometriosis
  • Consultancy services for linguistic validation of an endometriosis symptom diary and endometriosis impact scale
  • Endpoint review and regulatory support regarding the suitability of the Biberoglu & Behrman Scale (B&B) and Endometriosis Health Profile-30 (EHP-30) for supporting US product labelling claims in endometriosis
  • FDA PRO dossier updates and the development of Endometriosis Symptom Diary (ESD) and Endometriosis Impact Scale (EIS) user manuals
  • Review of a briefing book concerning a compound in development for the treatment of pain and other symptoms arising from endometriosis
  • Face and content validity of a new measure to assess symptoms associated with endometriosis
  • Development and face and content validation of a diary to assess symptoms associated with endometriosis
  • Development of disease-specific modules for endometriosis

Endpoint reviews with an FDA component

  • Diabetic foot ulcers
  • Diabetic macular oedema
  • Diarrhoea-predominant irritable bowel syndrome
  • Dysmenorrhea
  • Epilepsy
  • Epoietin alfa in chronic kidney disease
  • Functional digestive disorders (post-prandial distress syndrome)
  • Hereditary angioedema
  • Hypogonadism
  • Major depressive disorder
  • Pain
  • Pulmonary arterial hypertension
  • Retinal vein occlusion
  • Rheumatoid arthritis

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)

Eosinophilic gastroenteritis

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

Epilepsy

  • Mapping the health economic evidence landscape for anti-epileptic treatments
  • Systematic literature review and mixed treatment comparison for a treatment in epilepsy
  • Abstract review for the systematic literature review and mixed treatment comparison investigating treatments in epilepsy
  • Value dossier for an anticonvulsant medication for use in epilepsy
  • Evidence synthesis and modelling for an anticonvulsant medication in epilepsy
  • SMC submission for an anticonvulsant treatment for epilepsy
  • Brief literature review in epilepsy and search of FDA and EMA websites
  • Payer meeting and consultancy on an anti-epilepsy drug
  • Consultancy on an Italian model adaptation in epilepsy
  • Development of a US value dossier (meeting AMCP and WellPoint guidelines) and an expanded budget impact model on epilepsy
  • Cost-effectiveness analysis of two different anticonvulsant medications as adjunctive therapy for adults with partial refractory epilepsy in the US
  • Mixed treatment comparison summary for epilepsy

Dravet syndrome

  • Development of a composite trial endpoint for Dravet syndrome
  • Interviews on the development of a composite trial endpoint for Dravet syndrome
  • Manuscript on the development of a composite trial endpoint for Dravet syndrome
  • Publication support to disseminate findings from interviews with caregivers of children with Dravet syndrome, and independent qualitative analysis of findings

Lennox-Gastaut syndrome

  • Cost utility analysis model for Lennox-Gastaut Syndrome
  • Training with the client to discuss the Lennox-Gastaut Syndrome economic model/report and payer submission
  • Eliciting utilities in Lennox-Gastaut Syndrome
  • Assistance with responding to questions from the AWMSG and SMC on Lennox-Gastaut syndrome

Erectile dysfunction

  • Development of a symptom and QoL questionnaire on erectile dysfunction
  • Manuscript on the development of a questionnaire on treatment satisfaction in erectile dysfunction
  • International psychometric validation of the total symptom score (TSS) questionnaire in erectile dysfunction
  • Linguistic validation of the Rosenberg Self-Esteem Scale (RSES) questionnaire for erectile dysfunction into UK English
  • Linguistic validation and cognitive debrief of a self-esteem and relationship questionnaire for erectile dysfunction
  • FDA dossier for PRO instruments measuring the impact and symptoms of erectile dysfunction
  • Patient interviews to support the development of an FDA dossier on an erection hardness score questionnaire
  • Review of excel tables and a regulatory document for a treatment for management of erectile dysfunction

Esophogeal cancer

  • Payer value deck in esophogeal cancer
  • Burden of disease deck in esophogeal cancer
  • Response to payer questions in esophogeal cancer
  • Clinical trial analyses to support HRQoL in oesophageal cancer

Excess sebum (oily skin)

  • Development and validation of a questionnaire to assess patient’s satisfaction with treatment for oily skin (excess sebum)
  • Validation of the Excess Sebum Treatment Satisfaction Scale and the Patient Reported Excess Sebum Co-primary efficacy endpoint
  • Focus group sessions presentation on excess sebum
  • Cognitive debriefing interviews in excess sebum
  • Consultation on a methods study to validate primary and secondary endpoint measures in excess sebum
  • Initial psychometric validation of an oily skin questionnaire
  • Face and content validation of the oily skin PRO instruments in adolescents