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.

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

Hepatitis

Hepatitis A

  • Update to payer value deck in Hepatitis A
  • Payer material development for vaccines in hepatitis A
  • e-v@luate platform on vaccines for hepatitis A
  • Burden of disease literature review on hepatitis A in the UK and Ireland

Hepatitis B

  • Systematic literature review of a treatment for chronic hepatitis B
  • Preparation of a NICE submission for a hepatitis B drug
  • SMC submission for a treatment for chronic hepatitis B
  • Database analysis to calculate the economic burden of hepatitis B in the UK

Hepatitis C

  • Therapeutic area strategy analysis and reporting in chronic hepatitis C virus
  • Biomarkers in the treatment of hepatitis C virus infected patients – personalised medicine
  • Maximizing the use of a treatment for hepatitis C-infected patients through personalised medicine – extending the tool to additional treatments
  • Treatment algorithm for hepatitis C treatment
  • One-pager value communication tool for Hepatitis C
  • Comprehensive literature research in chronic hepatitis C in Asian countries
  • Database development and analysis in hepatitis C
  • Concept elicitation and cognitive debriefing interviews with hepatitis C patients in multiple countries
  • Development of an EMA summary document for several instruments used in hepatitis C trials
  • Development of a PRO outcomes summary document and communications support in hepatitis C trials
  • Description, interpretation and analysis of pooled data related to the use of several questionnaires, scales and screening tests in three hepatitis C clinical trials
  • Conceptual model for patients with hepatitis C
  • Psychometric validation of a hepatitis C symptom checklist using phase III trial data
  • Treatment patterns, healthcare utilization and costs associated with the hepatitis C virus in Japan
  • Selection of PRO measures for hepatitis C trials

Typhoid

  • Burden of disease literature review on typhoid in the UK and Ireland

Yellow fever

  • Burden of disease literature review on yellow fever in the UK and Ireland

Rabies

  • Burden of disease literature review on rabies in the UK and Ireland

Tetanus

  • Burden of disease literature review on tetanus in the UK and Ireland

Pertussis

  • Data review on the burden of pertussis and other infections
  • Burden of disease literature review on pertussis in the UK and Ireland

Surgical infections

  • Development of an interactive model for skin and nasal antiseptic for infection prevention, allowing users to tailor settings to stakeholders’ specific circumstances at a regional or local level or within hospital departments
  • Scientific communication of a budget impact model for prevention of surgical skin infections

Surgery

  • Identification of data inputs for a Canadian budget impact model in surgery
  • Research into resource utilisation for post-operative pain for HE modelling
  • Development of an economic model for treatment in post-liver transplant in paediatric patients
  • Value dossier on a treatment for post liver transplant in paediatric patients
  • AMCP dossiers for several surgical products
  • Value slide deck for bariatric surgery
  • Training in a manual compression device for surgery
  • Strategic review of European market access potential for a surgical device
  • General consultancy on economics, quality of life and reimbursement in lung volume reduction surgery in emphysema
  • Development of a PRO questionnaire in abdominoplasty (tummy tuck)
  • Consulting on PRO claims and an FDA dossier on abdominoplasty (tummy tuck)
  • Publications on the tummy tuck development and validation project
  • Phase III analysis of a tummy tuck clinical trial
  • Pre- and post-surgery research study in hidradenitis suppurativa
  • Protocol review, case report form and analysis plan for a treatment to prevent complications of vascular surgery
  • Matched cohort pulmonary embolism evaluation in orthopaedic surgery in Japan
  • Manuscript on the incidence of venous thromboembolism following major abdominal surgery
  • Abdominal surgery cohort study to evaluate the risk of venous thromboembolism
  • Non-parametric statistics PRO endpoints on cosmetic surgery on the chin
  • Development of a photonumeric guide and PRO measure of surgical scarring
  • Support for a value dossier submission for a treatment for moderate surgical bleeding in Asia-Pacific
  • Training work on post-operative nausea and vomiting
  • Delphi panel to estimate nursing time in post-operative pain management

Systemic mastocytosis

  • Statistical analysis of a clinical trial PRO and ClinRO data in advanced systemic mastocytosis
  • Conference abstract and poster for a PRO analysis in advanced systemic mastocytosis
  • PRO questionnaire development for symptoms of aggressive and indolent systemic mastocytosis
  • Development of a PRO questionnaire in indolent systemic mastocytosis – Longitudinal data collection
  • Psychometric evaluation and regulatory dossier on indolent systemic mastocytosis (ISM-SAF)
  • Observational study to inform the use of the ISM-SAF as a clinical trial screening tool in indolent systemic mastocytosis
  • Longitudinal data analyses and development of a PRO questionnaire in indolent systemic mastocytosis

Spinal muscular atrophy

  • Qualitative research to support development of a conceptual model and COA strategy in spinal muscular atrophy

Systemic sclerosis / Scleroderma

  • Review of PROs in systemic sclerosis/scleroderma
  • Brief literature review to inform endpoint strategy recommendations for interstitial lung disease in systemic sclerosis (SSc-ILD)

Neurogenic orthostatic hypotension

  • Defence of the use of the Orthostatic Hypotension Questionnaire (OHQ) to demonstrate treatment benefit and labelling claim in neurogenic orthostatic hypotension
  • Validation of the OHQ in neurogenic orthostatic hypotension using clinical trial data
  • Key opinion leader interviews on neurogenic orthostatic hypotension
  • Evaluation of the current measurement strategy in neurogenic orthostatic hypotension

Masseter muscle

  • Development and validation of a PRO for masseter muscle hypertrophy
  • In-trial validation of a PRO for masseter muscle prominence in Canada and Taiwan
  • Development and psychometric evaluation of severity measures in masseter prominence
  • Conceptual equivalency and psychometric evaluation of PRO and ClinRo measures of masseter muscle prominence
  • Interim psychometric evaluation of the lower facial shape questionnaire in masseter muscle hypertrophy

Long-chain fatty acid oxidation disorders

  • Qualitative research to explore and support the assessment of the patient experience and impact on functioning of long-chain fatty acid oxidation disorders
  • Qualitative interviews on long-chain fatty acid oxidation disorders

Growth hormone deficiency

  • Strategic literature review to select PRO for a paediatric growth hormone deficiency trial
  • Establishing support of content validity for the modified Injection Pen Assessment Questionnaire (IPAQ) in growth hormone deficiency
  • Injection Pen Assessment Questionnaire (IPAQ) field study in growth hormone deficiency

GNE myopathy

  • Review and support for the development of a FDA dossier in patients with GNE Myopathy
  • Development of a manuscript describing the GNE Myopathy Functional Activity Scale (GNEM-FAS) validation
  • Development of a user manual for the GNEM-FAS validation
  • Analysis of the GNEM-FAS validation
  • Support for translations of the GNEM-FAS
  • Post-hoc analyses to aid interpretation of change in GNE Myopathy endpoints including the primary endpoint of the strength composite score