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.

Interstitial lung disease

  • Consulting to help inform a PRO strategy for pulmonary hypertension in interstitial lung disease (PH-ILD)
  • Brief literature review to inform endpoint strategy recommendations for interstitial lung disease in systemic sclerosis (SSc-ILD)

Nasal polyps

  • Quantitative validation of symptom scores in nasal polyposis
  • Characterisation of symptoms and impacts of severe nasal polyps

Emphysema

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

Respiratory syncytial virus

  • Core value dossier for a treatment for respiratory syncytial virus
  • Core value dossier update in respiratory syncytial virus prophylaxis to support the roll-out of a new liquid formation
  • Value dossier update on respiratory syncytial virus
  • Payer objection handlers to support treatment in secondary hyperparathyroidism (SHPT) and respiratory syncytial virus
  • Economic evaluation of a treatment for respiratory syncytial virus
  • Observational study and claims analysis of respiratory distress in infants with respiratory syncytial virus
  • Development of an evidence package for a COA strategy for paediatric respiratory syncytial virus
  • Content validation of a COA strategy for paediatric respiratory syncytial virus
  • Exit interviews with caregivers and clinicians in a prospective study to assess the Paediatric Respiratory Syncytial Virus Electronic Severity and Outcome Rating System (PRESORS)
  • Content validation of a COA strategy for respiratory synctial virus in the elderly or in those with respiratory compromise

Bronchitis

  • Development of a cough and sputum questionnaire in chronic bronchitis in 7 languages
  • Validation of a cough and sputum questionnaire in chronic bronchitis
  • Development and validation of a patient diary for evaluating acute exacerbation of chronic bronchitis
  • Conducting European focus group sessions for acute exacerbation of chronic bronchitis
  • Validation of a patient diary for evaluating acute exacerbation of chronic bronchitis (AECB)

Macular degeneration

  • Rapid payer research to inform investment decisions in diabetic macular edema
  • Cost-effectiveness model to inform investment decisions in diabetic macular edema
  • Mixed treatment comparison for treatment of patients with wet age-related macular degeneration
  • Development and validation of a screener and QoL module in macular degeneration
  • Burden of illness in wet age-related macular degeneration in Japan
  • Literature review of visual function literature to support the National Eye Institute Visual Function Questionnaire (NEI-VFQ) in age-related macular degeneration
  • Cross-sectional burden of illness study for age-related macular degeneration
  • FDA claim strategy and endpoint review of a visual function questionnaire in age-related macular degeneration and diabetic macular edema
  • Content validation of a visual function questionnaire in diabetic macular edema

Ovarian cancer

  • Payer value slide kit in ovarian cancer
  • FAQ guide in ovarian cancer
  • Market access tools implementation guide in ovarian cancer
  • Standalone budget impact models in ovarian cancer
  • Evaluation of patient perspectives on oral versus intravenously-administered treatments for ovarian cancer
  • Survey development for treatment preference in ovarian cancer
  • Provision of consulting services to support PRO labelling and publication strategy for a clinical development program in ovarian cancer
  • Cognitive debriefing interviews to assess usability of an ePRO device for use in forthcoming clinical trials in ovarian cancer
  • Literature and PRO review in ovarian cancer and pain consultancy
  • Literature review and consultancy on ovarian cancer
  • Strategic consultation on oncology endpoints and analysis in ovarian cancer
  • Psychometric evaluation and score interpretation of the national comprehensive cancer network-functional assessment of cancer therapy ovarian symptom Index-18 administered with patients who have advanced ovarian cancer

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

Myelofibrosis

  • Global value dossier and e-v@luate platform for a treatment in myelofibrosis
  • Quality of life analysis, value proposition and value messages for a treatment in myelofibrosis
  • Modification of a web-based patient survey to assess QoL, economic impact and work productivity for patients with myeloproliferative neoplasms
  • Development and documentation of a PRO questionnaire for use among patients with myelofibrosis in second line treatment
  • Score interpretation guidance on the use of the Myelofibrosis Symptom Assessment Form (MF-SAF) diary in treatment resistant patients
  • Post-hoc analysis of PRO outcomes in a phase II clinical trial in myeloid metaplasia

Mesothelioma

  • Local market adaption of economic models for 2nd line mesothelioma treatment
  • Consultancy and training on a shortness of breath claim in mesothelioma

Multiple myeloma

  • Development of a manuscript on the burden of relapse in multiple myeloma
  • Value dossier for treatment in multiple myeloma
  • Development of a conference poster on multiple myeloma
  • Research strategy and publication plan to support the burden of relapse in multiple myeloma
  • Communication of the findings from patient and physician interviews on the burden of relapse in multiple myeloma
  • Conference poster on the burden of relapse in multiple myeloma
  • Meta-analysis, mixed treatment comparison and multiparameter evidence synthesis of the efficacy of a treatment for multiple myeloma
  • Quality of life analysis of clinical trial data in multiple myeloma
  • Burden of disease deck, payer value dossier deck and frequently asked questions deck in multiple myeloma
  • European survey quantifying the impact of novel treatments on quality of life in multiple myeloma
  • Mixed treatment comparison of a treatment for multiple myeloma
  • Standalone budget impact models in multiple myeloma
  • Analysis of a treatment in multiple myeloma
  • Analysis of PROs in randomised controlled clinical trial in multiple myeloma
  • Statistical analysis of the minimally important differences and responder thresholds in myeloma
  • Sensitivity analysis in myeloma
  • PRO analysis in multiple myeloma
  • PRO analysis of clinical trials on a treatment for multiple myeloma
  • Patient interviews in multiple myeloma
  • Manuscript and publication support on the use of minimal residual disease testing by US physicians who treat patients with multiple myeloma
  • Manuscript on multiple myeloma quality of life trial results
  • Conference presentation of PRO study results in multiple myeloma
  • Poster reporting results from multiple myeloma patient interviews
  • FDA regulatory review on a treatment for multiple myeloma
  • Clinical trial analyses to support HRQoL in multiple melanoma
  • Value dossier and e-v@luate platform for a drug used in the treatment of relapsed/refractory multiple myeloma (RRMM)
  • Global value dossier and e-v@luate platform for a treatment in RRMM
  • Quality of life analysis for treatment of RRMM
  • Quality of life analysis, SAP and reporting for a treatment in RRMM
  • Full analysis and QoL endpoints in RRMM
  • German PRO analysis to support submission of a study on a biological therapy drug used in RRMM

Liver cancer

  • Development of a HEOR strategy for treatment of hepatocellular cancer
  • Clinical trial analyses to support health-related quality of life in advanced hepatocellular carcinoma
  • Landscape analysis for ablation in liver cancer

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

Bladder cancer

  • Burden of disease deck in bladder cancer
  • Payer value deck in bladder cancer
  • Frequently asked questions in bladder cancer
  • Payer implementation guide in bladder cancer
  • Burden of disease deck, payer value dossier deck and frequently asked questions deck in 2nd line bladder cancer
  • Burden of disease deck in non-muscle invasive bladder cancer
  • Payer value deck update in 2nd line bladder cancer
  • Standardization of economic models in bladder cancer
  • Qualitative research in bladder cancer
  • Clinical trial analyses to support health-related quality of life in bladder cancer
  • ‘Fit for purpose’ tools review in bladder cancer
  • Development of a new PRO measure in bladder cancer
  • AMNOG analyses to support health-related quality of life in bladder cancer

Musculoskeletal pain

  • Conference abstract and poster for early decision modelling in acute pain
  • Strategic literature review of chronic pain
  • Competitive assessment and burden of illness in chronic low back pain
  • Content confirmation and testing of the Roland Morris Disability Questionnaire (RMDQ) and Pain NRS Personal Digital Assistant in chronic low back pain
  • Development of a responder index in low back pain
  • Manuscript on the chronic low back pain responder index
  • Development of a PRO measure of stiffness in acute low back pain
  • Focus group interviews with patients with chronic low back pain
  • Gap analysis and strategic recommendation for PRO and market access studies in chronic low back pain and diabetic peripheral neuropathy
  • Mode of Administration (MOA) equivalency study in lower back pain
  • Consulting on PRO analysis and study design of trials in chronic low back pain
  • Burden, economics, epidemiology and treatment patterns in chronic low back pain
  • Qualitative exit interviews to assess the patient experience of treatment and clinical trial participation among patients with chronic low back pain
  • Gap analysis and review of PRO measures in low back pain and neck pain
  • Development of a briefing document on the modified Brief Pain Inventory – Short Form (mBPI-SF) in acute musculoskeletal pain
  • Critical review of PRO instruments in fatigue and pain in rheumatic disease
  • PRO literature review in pelvic pain
  • Patient perspective literature review for chronic pelvic pain in both men and women

Muscle wasting

  • COA review and development for muscle wasting associated with chronic illness
  • Exit interviews to explore patient disease burden, treatment satisfaction and clinical trial participation in muscle wasting associated with chronic obstructive pulmonary disease (COPD)
  • Qualitative research to support the identification of key impacts on physical functioning and activities of daily living in patients with muscle wasting

Fibromyalgia

  • Literature review of PROs and endpoints of pain in fibromyalgia
  • Competitive assessment and burden of illness in fibromyalgia
  • Assessment of the feasibility of achieving claims for cognitive functioning in fibromyalgia
  • Gap analysis and endpoint review in fibromyalgia
  • Validation of the fatigue Visual Analogue Scale (VAS) and Jenkins Sleep Scale for fibromyalgia
  • Development of a manuscript on fatigue and sleep triangulation results in fibromyalgia
  • Development of a manuscript on the use of the Jenkins Sleep Scale on patients with fibromyalgia
  • Focus groups to determine the best questionnaire to assess fibromyalgia and recommendations for clinical trials
  • Assessment of PROs in fibromyalgia
  • Development of a manuscript in fibromyalgia (reporting results from focus groups and Delphi panel phases)
  • Endpoint review of fatigue and functioning in fibromyalgia
  • Development of a conceptual framework for the measurement of fatigue in patients with fibromyalgia
  • Pilot testing interviews on fibromyalgia fatigue
  • Consultancy relating to the psychometric validation of the daily diary of fatigue symptoms in fibromyalgia (DFS-Fibro)
  • Manuscript reporting the results from the validation of the DFS-Fibro
  • PRO assessment in fibromyalgia and diabetic peripheral neuropathy
  • Development of a dossier on the Daily Diary of Fatigue Symptoms – Fibromyalgia (DFS-Fibro) and regulatory consultancy for fibromyalgia
  • Consultancy for fibromyalgia fatigue study
  • Post-hoc Rasch analysis of existing data from the DFS-Fibro
  • Validation study of the modified version of the Brief Pain Inventory – Short Form (mBPI-SF), MOS-S and 3 single item questions in fibromyalgia and diabetic peripheral neuropathy
  • Report of sleep problems in fibromyalgia
  • Burden, economics, epidemiology and treatment patterns in fibromyalgia

Dengue disease

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

Measles, mumps and rubella (MMR)

  • One-pager value communication tool for the measles, mumps and rubella (MMR) vaccine
  • Payer value deck for an MMR vaccine
  • e-v@luate platform on vaccines for MMR