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.

Alzheimer’s disease

  • Advisory panel on Alzheimer’s disease
  • Critical analysis and report to support the widespread use of a combination therapy in Alzheimer’s disease
  • Analysis and report generation of widespread use of combination therapy in Europe for the treatment of Alzheimer’s disease
  • Summary report on EMA marketing organisation for a treatment in Alzheimer’s disease
  • Budget impact model in Alzheimer’s disease
  • Disutility study in Alzheimer’s disease
  • Disutility of caregiver burden associated with Alzheimer’s disease in Japan
  • Health state development for mild cognitive impairment in Alzheimer’s disease
  • Early payer value deck for Alzheimer’s disease
  • Development of additional caregiver burden items for the Resource Utilization in Dementia Questionnaire for Alzheimer’s disease
  • Literature research and analysis on the Alzheimer’s disease landscape in Japan
  • Conceptual framework for the Alzheimer’s Disease Caregiver Preference Questionnaire (ADCPQ)
  • Linguistic validation of the ADCPQ into Chinese
  • Validation of the Alzheimer’s disease caregiver preference questionnaire
  • Evaluation of quality of life in cognitively impaired Alzheimer’s disease patients
  • Review of the Alzheimer’s Disease Activity Scale-cognitive subscale (ADAS-Cog)
  • Development of a COA strategy for mild-moderate symptomatic Alzheimer’s disease
  • Development of a trial-specific caregiver satisfaction and preference questionnaire for a treatment for Alzheimer’s disease
  • PRO instrument development, qualification quantitative component of content validity stage and in-trial psychometric analysis stage in mild cognitive impairment
  • Review of the University of California San Diego Performance-based Skills Assessment (UPSA) in Alzheimer’s disease
  • Cognitive debriefing of the Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL) questionnaire
  • Analysis of an open label extension study in Alzheimer’s disease

Anaemia

  • NICE consultancy for a treatment for chemotherapy-induced anaemia
  • Statistical pharmacoeconomic analysis of patient level data for a treatment for anaemia following chemotherapy
  • Linking a cost utility assessment model with a budget impact model for treatment for anaemia in cancer
  • Phase II cognitive interviews and regulatory support in inflammatory anaemia in cancer
  • Evaluation of the PRO landscape using a systematic literature review on chemo-induced anaemia in oncology
  • Patient consultations on anaemia
  • General consulting agreement for iron treatment in anaemia

Anaesthesiology

  • Economic analysis and trial design in hip replacement
  • Health economic endpoints for a locally-acting treatment to provide pain relief after surgery
  • Powerpoint storyboard to support and demonstrate an economic modelling tool in anaesthesiology
  • Preparation of a data collection questionnaire in anaesthesiology for local markets
  • Pricing and reimbursement guidelines on anaesthesia and analgesia for Europe, Canada and Australia
  • Evaluation of the cost of operating time in Japan in relation to anaesthesiology
  • Stakeholder needs analysis in anaesthesiology
  • Recommendation for the use of a PRO in a phase IIIb trial in anaesthesia and face/content validity testing
  • Feasibility of developing a composite endpoint to assess patients’ quality of recovery after surgery requiring anaesthesia and the use of a reversal agent
  • Advisory board on anaesthesia and analgesia
  • Productivity workshop on anaesthesia and analgesia
  • Consultation on PRO assessments and analysis on anaesthesia and analgesia
  • Strategy for FDA translation validity checklist in anaesthesia and analgesia
  • Development of a conceptual framework and SAP for a treatment for neuromuscular block
  • Feasibility study for the surgeon satisfaction questionnaire with quality of surgery related to neuromuscular block
  • Translation of the Bridion Operating Room Study into Japanese
  • Treatment effect analyses based on a Quality of Recovery questionnaire (QoR-40) and Reversal Agent Satisfaction Questionnaire (RASQ) in neuromuscular block
  • Development of a surgeon satisfaction questionnaire for anaesthetic block
  • Endpoint review and gap analysis in bone healing

Angina

  • Gap analysis of PRO measures to substantiate labelling claims in angina trials of a drug-eluting stent (DES)
  • Cognitive debriefing interviews and item finalization for a PRO for microvascular angina (MVA)

Angioedema

  • Telephone consultation on angioedema
  • Strategic PRO and ObsRO consulting of an angiotensin converting enzyme (ACE) inhibitor induced angioedema clinical trial database
  • Cognitive debriefing interviews in ACE inhibitor induced angioedema
  • Investigator training for the ACE inhibitor induced angioedema investigator rating scale
  • Translation and linguistic validation of clinician assessments in ACEI-Angioedema
  • Communications on clinician assessments in ACEI-Angioedema

Animal health

Canines

  • Qualitative activities to support validity and feasibility of the canine quality of life and treatment satisfaction measure administered via a cell phone application
  • Development of a user manual for canine dermatitis quality of life and treatment satisfaction
  • Psychometric evaluation of a revised canine dermatitis quality of life questionnaire
  • Clinical trial analysis and ad-hoc consultancy for a canine quality of life questionnaire
  • Exploration of canine-owner burden in various conditions and provision of recommendations for measurement
  • Psychometric evaluation and analysis of a revised canine dermatitis quality of life questionnaire

Felines

  • Building of a feline QoL tool for cats with GI lymphoma
  • Development and validation of an instrument to measure quality of life in cats
  • Development of a user manual for a feline quality of life tool

Anxiety

  • Validation of the SIS in anxiety
  • Manuscripts on the development and validation of the Sleep Impact Scale (SIS) in generalised anxiety disorder
  • PRO strategy in generalized anxiety disorder with functional digestive disorders / irritable bowel syndrome (IBS)

Artery diseases and high cholesterol

  • Literature review of burden of illness and cardiovascular risk group identification of symptomatic peripheral artery disease
  • Literature review and payer appraisals in peripheral artery disease
  • Budget impact and economic evaluation of a statin
  • Advisory board on arterial occlusive disease
  • Workshop communicating health economic data of an anticoagulant medication for deep vein thrombosis (DVT)
  • Development of a treatment satisfaction measure for an injectable low-density lipoprotein (LDL) cholesterol lowering medication
  • Costs for psychometric validation of the Injection-Treatment Acceptance Questionnaire (I-TAQ) in an independent observational study in hypercholesterolemia
  • Statistical consultancy to support use of the I-TAQ for a cholesterol-lowering medication
  • Production of a revised heart model for hypercholesterolaemia incorporating additional comments from country affiliates
  • Worldwide database analysis of statins and cholesterol levels
  • Probabilistic analysis of a statin model and advice on a pharmacoeconomic manuscript
  • Endpoint review for FDA-approved flushing claims in atherosclerosis

Arthritis

  • Manuscript and analysis on an anti-inflammatory treatment for arthritis
  • PRO literature review for two different anti-inflammatory drugs for the treatment of arthritis

Ankylosing spondylitis

  • Interactive cost-effectiveness model for a selective inhibitor treatment used for ankylosing spondylitis
  • Manuscript cost-effectiveness analysis of a treatment for ankylosing spondylitis in Norway
  • Workshop and FAQ development in immunology in ankylosing spondylitis
  • Development of a payer value deck in immunology in ankylosing spondylitis
  • Competitor review deck in ankylosing spondylitis
  • Total Brand FAQ deck and Total Brand Workshop in ankylosing spondylitis
  • Global value dossier and budget impact model for a biosimilar in ankylosing spondylitis
  • Competitor value story slide deck in ankylosing spondylitis
  • Payer slide kit in non-radiographic axial spondyloarthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on ankylosing spondylitis

Juvenile idiopathic arthritis

  • Workshop and FAQ development in immunology in juvenile idiopathic arthritis
  • Development of a payer value deck in immunology in juvenile idiopathic arthritis
  • Frequently asked questions deck in juvenile idiopathic arthritis

Osteoarthritis

  • Global value dossier and budget impact model for a biosimilar in osteoarthritis
  • Literature review of PROs and endpoints of pain in osteoarthritis
  • Literature review to support the use of COA measures in osteoarthritis
  • Competitive assessment and burden of illness study in osteoarthritis
  • Review of endpoints for clinical trials in osteoarthritis
  • Instrument review and assessment strategy in osteoarthritis
  • Mixed treatment comparison of two treatments for osteoarthritis of the knee
  • Mode of administration validation study for an electronic diary in back pain for osteoarthritis patients
  • Development and cognitive debriefing on a patient global response to a treatment measure in osteoarthritis pain
  • Translation and validation of the revised Hopkins Verbal Learning Test for osteoarthritis
  • Translation and validation of an osteoarthritis diary
  • Development of a measure of disease flare in osteoarthritis patients
  • Patient interviews to capture disease burden and unmet treatment needs in hand osteoarthritis
  • Mode of administration equivalency and usability testing of COA instruments in osteoarthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on osteoarthritis
  • Consulting on PRO analysis and study design of trials in osteoarthritis
  • Top up literature review of PROs in osteoarthritis
  • Gap analysis and review of PRO measures in osteoarthritis
  • Qualitative exit interviews to assess the patient experience of treatment and clinical trial participation among patients with osteoarthritis

Psoriatic arthritis

  • Systematic literature review and network analysis in psoriasis and psoriatic arthritis
  • Targeted literature review in psoriatic arthritis patients with concomitant moderate to severe psoriasis
  • Workshop and FAQ development in immunology in psoriatic arthritis
  • Development of a payer value deck in immunology in psoriatic arthritis
  • Competitor review decks in psoriatic arthritis
  • Competitor value story slide deck in psoriatic arthritis
  • Data checks and DEF amendments in psoriatic arthritis
  • HTA support regarding psoriatic arthritis submissions in Canada, Spain and the UK
  • Regulatory support on SMC questions on psoriatic arthritis work
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of psoriatic arthritis

Rheumatoid arthritis

  • Literature search, data extraction and report on rheumatoid arthritis
  • Cost-consequences manuscript on rheumatoid arthritis
  • Generating evidence to support the unmet need in rheumatoid arthritis
  • Measuring indirect and societal costs of morning stiffness in patients with rheumatoid arthritis
  • Manuscript on a treatment in rheumatoid arthritis
  • Review of an economic model to assess utility requirements for a treatment in rheumatoid arthritis
  • Utility study and economic model in rheumatoid arthritis
  • Review of European HTA requirements for treatment in rheumatoid arthritis
  • Adaptation of an economic model on treatment of rheumatoid arthritis for the USA
  • Value message testing for a biosimilar in rheumatoid arthritis
  • Objection handler in rheumatoid arthritis
  • Economic model on a treatment for rheumatoid arthritis
  • Budget impact model for a biosimilar in rheumatoid arthritis
  • Competitor review in rheumatoid arthritis
  • Competitor review of two JAK inhibitors in rheumatoid arthritis
  • Payer focused value communication on rheumatoid arthritis
  • Payer value proposition update in rheumatoid arthritis
  • Frequently asked questions on an immunology biosimilar for rheumatoid arthritis
  • Literature review of unmet need in rheumatoid arthritis
  • Literature review and recommendations for rheumatoid arthritis
  • Utility study in rheumatoid arthritis
  • Competitor value story in rheumatoid arthritis
  • Competitor value stories for two treatments of rheumatoid arthritis
  • Manuscript on a budget impact model for a cross-indication biosimilar in conditions including rheumatoid arthritis
  • Core value dossier, value deck and objection handler in rheumatoid arthritis
  • Update to an AMCP dossier for a rheumatoid arthritis biosimilar
  • Global value dossier and budget impact model for a biosimilar in rheumatoid arthritis
  • Workshop and FAQ development in immunology in rheumatoid arthritis
  • Development of a payer value deck in immunology in rheumatoid arthritis
  • Total Brand FAQ deck and Total Brand Workshop in rheumatoid arthritis
  • Review of PROs and preparation and writing of a PRO briefing document for the FDA on the treatment of rheumatoid arthritis
  • Generation of evidence to support the unmet need in rheumatoid arthritis
  • Modified Delphi Panel to gain consensus in rheumatology (rheumatoid arthritis)
  • Development of a PRO strategy in rheumatoid arthritis
  • Qualitative research in rheumatoid arthritis
  • Poster and manuscript on an indirect comparison of biologic treatments for TNF-IR rheumatoid arthritis patients
  • Systematic review to explore minimal important differences in PROs for rheumatoid arthritis
  • Meta-analysis of joint structural deterioration over time in minimally treated rheumatoid arthritis patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR)
  • Mixed treatment comparison of efficacy and safety of an immunosuppressant drug versus a TNF inhibitor drug in rheumatoid arthritis patients with DMARD-IR
  • Mixed treatment comparison of an oral drug used in the treatment of rheumatoid arthritis
  • Characterising and predicting treatment response to rheumatoid arthritis biologic therapy
  • Literature review of unmet need in rheumatoid arthritis
  • Mixed treatment comparison of a treatment for rheumatoid arthritis populations – DMARD-IR and MTX-naive patients
  • Q&A and mixed treatment comparison on a treatment for rheumatoid arthritis
  • Indirect comparison of a monotherapy treatment for rheumatoid arthritis patients with DMARD-IR
  • Face and content validity testing of a tiredness item in a sample of rheumatoid arthritis patients
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis
  • Psychometric evaluation of a PRO in rheumatoid arthritis
  • Evaluation of fatigue in rheumatoid arthritis using a PRO instrument
  • Patient interviews on rheumatoid arthritis
  • Patient interviews to capture disease burden and unmet treatment needs in rheumatoid arthritis
  • Support in development and analyses of a patient support programme in indications including rheumatoid arthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on rheumatoid arthritis
  • Top up literature review of PROs in rheumatoid arthritis
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis

Asthma

  • Systematic literature review on treatment patterns and burden of illness in asthma
  • Literature review, analysis and communications for asthma costs
  • Literature review of critical handling errors in asthma
  • Real-world evidence literature review in asthma
  • Landscape analysis in asthma and model assessment to support positioning paper
  • Structured literature reviews for paediatric wheeze detection
  • Rapid structured literature review of nebulisation inhalation efficiency in paediatric asthma and other respiratory conditions
  • Competitor literature review for real world evidence in asthma
  • Advisory board meeting on a literature review in asthma
  • Simple cost-utility model and targeted literature review for the treatment of asthma
  • Budget impact model and manuscript on asthma
  • Consultancy on exploratory economic modelling in severe asthma
  • Update to the pilot inference model for an inhaler used in the treatment of asthma
  • Health economic model in asthma
  • Economic model of asthma therapies for NICE
  • Economic model of combination asthma therapies for NICE
  • Resource use costing in asthma and communicating product value to a local payer audience
  • Global value dossier update on paediatric asthma
  • Global value dossier update and e-v@luate upload for an asthma device
  • Development of a mini global value dossier for an asthma device
  • e-v@luate platform development for paediatric asthma
  • Updates to critical handling error manuscript in asthma
  • Development of a manuscript in mild persistent asthma in specific geographies
  • Update to a critical handling errors manuscript in asthma
  • Preparation of a submission dossier for NICE on paediatric inhaled corticosteroid (ICS) drug use in asthma
  • Several conference posters on asthma, an asthma model, and economic analysis for the treatment of asthma
  • Advisory panel in asthma
  • Regulatory strategy consultancy in asthma
  • Consultancy on obtaining FDA approval of a treatment satisfaction claim for a new asthma treatment
  • Confirmation of an endpoint model for patients with asthma currently receiving treatment
  • PRO consulting on an asthma program for labelling
  • Cognitive debriefing to confirm the face and content validity of secondary endpoint questions in asthma
  • Database analysis and manuscript assessing death rate and hospitalisation rate in asthmatics
  • Development of a conceptual model and conceptual framework for the measurement of asthma control
  • Testing of a conceptual model of asthma in adolescents
  • Development of a symptom-based PRO instrument for adults and adolescents with asthma
  • Exit interviews to provide additional evidence of content validity for a quantitative study in asthma
  • Exit interviews on a connected inhaler system for asthma
  • Cognitive debriefing interviews in asthma
  • Validation of the Asthma Control Questionnaire (ACQ) using trial data
  • Manuscript on the psychometric validation of the ACQ report
  • Analyses of the ACQ
  • Conference poster reporting a ROC analysis performed to define cutpoints for the ACQ
  • Development of a questionnaire to assess control in children with paediatric asthma
  • Longitudinal validation of the Childhood Asthma Control Test (C-ACT)
  • Analysis and abstract on the longitudinal validation of the C-ACT
  • Validity assessment of the C-ACT in Japanese children
  • Validity assessment of the C-ACT in Hong Kong Chinese children
  • Complementary analyses on the C-ACT
  • Minimal clinically important differences for the C-ACT and symptom-free days/rescue medication–free days in paediatric asthma populations
  • Consulting on the linguistic validation of the C-ACT
  • Translation of the C-ACT
  • Equivalency testing of the modified Childhood Asthma Control Test (C-ACT) in children with mild to severe asthma
  • Cognitive debriefing of the Asthma Symptom and Control Diary (ASCD)
  • Linguistic validation of the Inhaled Corticosteroid Questionnaire (ICQ) into US English
  • Exit interviews and evaluation of the psychometric properties of the Asthma Daily Symptom Diary (ADSD) in severe asthma
  • Quantitative study to confirm the content validity of the ADSD
  • Development of a preference-based instrument specific to asthma