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.

Lymphomas

B-cell lymphoma

  • Payer evidence dossiers in B-Cell lymphoma
  • Development of a budget impact model for primary mediastinal B-cell lymphoma (PMBCL)
  • Literature review and preparation of a PRO strategy in large B-cell lymphoma
  • Burden of diffuse large B-cell lymphoma on patients and caregivers
  • e-v@luate platform in diffuse large B-cell lymphoma

Hodgkin’s lymphoma

  • Payer evidence dossiers in non-Hodgkin’s lymphoma
  • Early payer engagement deck in classical Hodgkin’s lymphoma
  • Analyses of endpoints in oncology: Statistical analyses in Hodgkin’s lymphoma
  • Clinical trial analyses to support health-related quality of life in Hodgkin’s lymphoma

Non-Hodgkin’s lymphoma

  • Update of a payer evidence dossier in non-Hodgkin’s lymphoma
  • Literature review and conceptual mapping in non-Hodgkin’s lymphoma
  • Strategic PRO endpoint support, gap analysis and patient interviews in a biological therapy treatment for non-Hodgkin’s lymphoma
  • Validation of a patient satisfaction questionnaire in non-Hodgkin’s lymphoma
  • Conference poster and slide deck on non-Hodgkin’s lymphoma
  • Manuscript on a budget impact model for a cross-indication biosimilar in diffuse large B-Cell lymphoma, follicular lymphoma, follicular non-Hodgkin’s lymphoma

Lymphomas (other)

  • Core value dossier and value proposition in cutaneous T-cell lymphoma
  • Development of a budget impact tool for a treatment for chronic lymphatic lymphoma for Spain
  • Support programme for reimbursement submissions in cutaneous T-cell lymphoma
  • Strategic consulting for a lymphoma trial
  • Clinical trial analysis of health-related quality of life data in patients with previously untreated follicular lymphoma
  • Manuscript on a budget impact model for a cross-indication biosimilar in diffuse large B-Cell lymphoma, follicular lymphoma, and follicular non-Hodgkin’s lymphoma

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
  • Burden of blindness study on inherited retinal degenerations
  • Survey protocol for a burden of blindness study
  • 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

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

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

Medical Devices

Allergic conditions

  • Focus groups assessing patient experience with nasal spray in allergic rhinitis, analysis of results and development of a report on concept elicitation and cognitive debriefing
  • Validation of the preference module of the Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q)
  • Manuscript on the development of the EARNS-Q
  • Regulatory support for the EARNS-Q
  • Preference questionnaire on allergic rhinitis spray devices

Cardiovascular disease

  • Demonstrating the value of a transcatheter heart valve in aortic stenosis
  • Payer research on a device for symptomatic peripheral arterial disease
  • Gap analysis of PRO measures to substantiate labelling claims in angina trials of a drug-eluting stent (DES)
  • Development and validation of patient and clinician tools for myocardial infarction imaging
  • Analysis and reporting of myocardial infarction imaging validation study data
  • Clinician and patient satisfaction in an observational study in myocardial infarction SPECT imaging
  • Validation of clinician and patient questionnaires for myocardial infarction imaging
  • Demonstrating the value of a transcatheter heart valve in aortic stenosis
  • General consulting on a new stent device
  • Report on the cost of diagnosing vascular diseases with an MRA as the primary imaging modality

Central nervous system/neurology

  • Advisory board for a clinical screening tool for overactive bladder in multiple sclerosis (MS)
  • Development and validation of a clinical screening tool for overactive bladder in MS
  • Validation of a brief series of questions with a subgroup of MS patients

Dermatology

  • Testing PRO measures in electronic devices for rosacea

Endocrinology and metabolic diseases

  • Development of a manuscript on patient perceptions of prefilled insulin delivery devices
  • Consultation on a market research study on patient perceptions of pre-filled insulin pens
  • Injection Pen Assessment Questionnaire (IPAQ) field study in growth hormone deficiency
  • Establishing support of content validity for the modified Injection Pen Assessment Questionnaire (IPAQ) in growth hormone deficiency
  • Development of an instrument to assess subject perception of two gastric bands in obesity

Gastrointestinal diseases

  • Development of a global value dossier and budget impact model for capsule endoscopy for colonoscopy
  • Global value dossier for a therapy device in refractory ascites
  • Translation to support development of a value dossier and budget impact model in capsule endoscopy for colonoscopy
  • Patient Assessment of Constipation Symptoms (PAC-SYM) and analysis of a skin patch containing an opioid pain medication
  • Managing patients with stoma: Adaptation of a Quality of Life Index (QLI) questionnaire to current needs for colostomy patients

Haematology

  • Development and testing of a novel web-based tool to evaluate patient preference for a reconstitution device for haemophilia A in a real-world setting

Immunology

  • Strategic consultancy on physician attitudes and preferences regarding adult vaccinations
  • Demonstrating the value of antibiotic resistance testing software
  • Measurement strategy to demonstrate efficacy of medical devices in patients with pigmented villonodular synovitis (PVNS) or tenosynovial giant cell tumour (dTGCT)

Infectious diseases

  • Systematic literature review on the indirect protection from the HPV vaccination
  • Value demonstration and implementation plan for a new HPV test
  • Value pack for a HPV vaccine
  • Training sales reps on an interactive model for a HPV vaccine
  • Update of a budget impact model for a HPV vaccine
  • Cost-effectiveness analysis of a HPV vaccine for Spain
  • HTA submission for a HPV vaccine
  • Manuscripts on the German and Spanish cost-effectiveness analysis of a HPV vaccine
  • Analysis and reporting on the budget impact of a HPV vaccine
  • Two manuscripts on an influenza vaccine for patients at risk and patients over 65 years old in France
  • Conference poster on the cost effectiveness of adjuvant influenza vaccination in France
  • Update of a value dossier on an influenza vaccine
  • Cost-effectiveness analysis of an influenza vaccine
  • Review of influenza vaccine uptake data
  • Updating an economic model of influenza vaccination (phase 1) – update of a model in patients aged over 65 years in France and the UK
  • Communications package for an influenza vaccine
  • Economic value dossiers for influenza vaccines in a) an unprimed paediatric population and b) a primed school age population (intranasal delivery) including literature review, gap analysis and recommendations
  • Economic evaluation of a workplace influenza vaccination in Russia
  • Communication of the economics of an influenza vaccine
  • Manuscripts on the health economics of a pneumococcal vaccine
  • Brief adaptation of a Markov model for a HPV vaccine
  • Adaptation of a Markov model on a HPV vaccine to Belgium
  • Development of a rationale for the need for a HPV vaccine
  • Communications package for an influenza vaccine
  • Adaptation of an influenza vaccine model to Belgium
  • Regulatory support for the validation of a questionnaire for influenza vaccination

Oncology

  • Cognitive debriefing interviews to assess usability of an ePRO device for use in forthcoming clinical trials in ovarian cancer

Ophthalmology

  • Formal recommendations on a regulatory briefing document for intraocular cataract lenses
  • Development of a PRO questionnaire to assess implantation of an intraocular lens in cataract patients
  • Cognitive interviews for the development of a PRO to assess intraocular lenses in cataract patients
  • Scientific dissemination of the patient-reported intraocular lens questionnaire
  • Etiology and meta-analysis of posterior cacular opacification comparing two lens types
  • Support on the intraocular cataract lenses (IOL) Expert Focus Group
  • Manuscript on HRQoL trial results of a new lens

Respiratory system

  • Global value dossier update and e-v@luate upload for an asthma device
  • Value proposition for a new metered dose inhaler to treat chronic obstructive pulmonary disease (COPD)
  • Structured literature review and qualitative interviews with payers/HCPs on a device for COPD
  • Development of a mini global value dossier for an asthma device
  • Structured literature reviews for paediatric wheeze detection
  • Rapid structured literature review of nebulisation inhalation efficiency in paediatric asthma and other respiratory conditions
  • Validation of the preference module of the Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q)
  • Manuscript on the development of the EARNS-Q
  • Focus groups assessing patient experience with nasal spray in allergic rhinitis, analysis of results and development of a report on concept elicitation and cognitive debriefing
  • Regulatory support for the EARNS-Q
  • Preference questionnaire on allergic rhinitis spray devices
  • Update to the pilot inference model for an inhaler used in the treatment of asthma
  • PRO strategy support for an inhaler treatment for COPD
  • Exit interviews on a connected inhaler system for asthma

Surgery and wound care

  • Training in a manual compression device for surgery
  • Strategic review of European market access potential for a surgical device
  • Value demonstration on a new wound care technology and the cost of pain management, allowing data to be tailored for local markets and local payers
  • AMCP dossiers for several surgical products
  • Identification of data inputs for a Canadian budget impact model in surgery

Urology and urogenital diseases

  • Systematic review of lithotripters for ureterolithiasis

Women’s health

  • Manuscript publication on a monthly contraceptive device
  • Modification, development and validation of an existing tool in order to explore satisfaction and tolerability for an intrauterine device (IUD) versus oral contraceptives
  • Modification of the EVAPIL-R in order to explore tolerability for an intrauterine system (IUS) versus an implantable contraceptive

Other

  • Value strategy training on access to medical devices
  • Panel and presentation on PRO research on medical devices

Meibomian gland dysfunction

  • Gap analysis and development in meibomian gland dysfunction
  • Publication support for PRO gap analysis and PRO measures in meibomian gland dysfunction

Melanoma

  • Adaptation of a multi-indication value-based pricing model in melanoma to China
  • Literature review in metastatic melanoma treatment patterns
  • Scientific communication of a systematic literature review on caregiver burden in advanced metastatic melanoma
  • Global value dossier for a treatment in melanoma
  • Development of global market access materials (disease burden slide deck, payer value story and FAQs) in metastatic melanoma to support local access teams
  • Payer slide decks and objection handler update in metastatic melanoma
  • Implementation guide in metastatic melanoma
  • Burden of disease deck update in ipi refractory and ipi naïve advanced melanoma
  • Payer value proposition deck update in ipi refractory advanced melanoma
  • Payer value proposition deck update in ipi naïve advanced melanoma
  • Updated implementation guide in melanoma
  • Frequently asked questions deck in ipi refractory and ipi naïve advanced melanoma
  • Updated burden of disease deck, payer value dossier decks and obstacle handler in a treatment for refractory & naïve melanoma
  • Development of a budget impact model for adjuvant melanoma
  • KOL interviews and primary research into treatment patterns in adjuvant melanoma
  • Payer value deck and response to payer questions in adjuvant melanoma
  • Payer value deck and response to payer questions update in advanced melanoma
  • Burden of disease deck in adjuvant melanoma
  • Burden of disease and payer value deck in adjuvant and advanced melanoma
  • Standardization of economic models in melanoma
  • Value-based model in melanoma
  • Multi-indication budget impact model in melanoma
  • Global model update and country adaptations for a multi-indication value-based pricing (VBP) model on melanoma
  • Adaptation of a value-based pricing multi-indication global model in oncology to Greece
  • Strategic communications planning in melanoma
  • Update to a Belgian value-based pricing model in melanoma
  • Updates to a Health Impact Projection (HIP) model in adjuvant melanoma and unresectable or metastatic melanoma
  • Preparation of a genomics methods paper in melanoma
  • Summary presentation of a workstream in melanoma
  • Caregiver burden in advanced melanoma
  • Caregiver burden in melanoma in the EU
  • Evidence synthesis on the comparative effectiveness of systemic therapies for unresectable stage IIIc and stage IV melanoma
  • Pilot patient interviews in melanoma
  • Exploratory analyses of endpoints in oncology: Statistical analyses in melanoma
  • Analyses of endpoints in oncology: Statistical analyses in first-line melanoma
  • Clinical trial analyses to support the relationship between adverse events and health-related quality of life, health status and work productivity in melanoma
  • Clinical trial analyses to support health-related quality of life in melanoma: AMNOG analyses for combination arm therapy
  • Network meta-analysis on the efficacy of first line treatment for unresectable stage IIIC/IV melanoma
  • AMNOG analyses to support health-related quality of life in melanoma

Menopause and hormone replacement therapy

  • Health economics on the menopause
  • Cost utility analysis of hormone replacement therapy (HRT)
  • Observational study of HRT
  • Cognitive debriefing of a women’s health screening tool
  • Consultancy on FDA documents on the menopause
  • Psychometric validation of the SAM/WSM using PNS validation study data
  • Literature review of HRT outcomes in the menopause
  • Development of a conceptual model for vasomotor symptoms in post-menopausal women
  • Trial of two drugs used to treat menopausal symptoms
  • Pilot testing of a paper hot flash diary and questionnaire on the menopause
  • Development of a PRO instrument for measuring mood swings and sleep problems resulting from vasomotor symptoms during the menopause
  • Development of a briefing document for measuring the impact of menopausal hot flushes
  • Development of a PRO for breast pain/pressure and vaginal bleeding/spotting for female patients on HRT
  • Manuscript reporting results of qualitative work to support development of a breast pain daily diary (BP-DD) and vaginal bleeding/spotting daily diary (VBS-DD)

Menstruation and dysmenorrhea

  • Provision of regulatory support for use of the Pictorial Blood Loss Assessment Chart (PBAC) in women’s health
  • Development of an ePRO for adult and adolescent dysmenorrhea
  • Regulatory consultation on dysmenorrhea assessments for an FDA type C meeting
  • Endpoint strategy in dysmenorrhea

Mesothelioma

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

Meta-analyses, indirect comparisons and mixed treatment comparisons

  • Breast cancer
  • Cataracts
  • Cervical cancer
  • Chronic obstructive pulmonary disease (COPD)
  • Colorectal cancer
  • Dementia
  • Epilepsy
  • Heart failure
  • HIV
  • HPV
  • Irritable bowel syndrome with constipation
  • Kidney disease
  • Leukaemia
  • Lung cancer (non-small cell)
  • Melanoma
  • Miscarriage
  • Multiple myeloma
  • Posterior cacular opacification
  • Psoriasis
  • Psoriatic arthritis
  • Pulmonary arterial hypertension
  • Rheumatoid arthritis
  • Stroke
  • Wet age-related macular degeneration

Metachromatic leukodystrophy

  • Understanding and documenting the disease burden of metachromatic leukodystrophy
  • Support of patient survey study development among patients with metachromatic leukodystrophy
  • Web-based survey implementation and analytic consulting support in metachromatic leukodystrophy
  • Clinical outcome assessment strategy development and validation in metachromatic leukodystrophy

Metastatic bone disease

  • Pre-screen interviews for the relative resource utilisation of intravenous and subcutaneous drug administration in metastatic bone disease
  • Research to validate and investigate the relative resource utilisation of intravenous and subcutaneous drug administration in metastatic bone disease

Migraine

  • Literature review of cardiovascular disease in migraine patients
  • Systematic literature review in migraine
  • Development of a PRO measure in chronic adolescent migraine
  • Statistical analysis plan for in-trial psychometric validation of the assessment of chronic migraine symptoms and impacts measures
  • Gap analysis and assessment of PROs in migraine
  • Development of a PRO measure in postdrome migraine
  • Development of an FDA briefing document and regulatory support in chronic migraine
  • Qualitative interviews in chronic migraine headaches
  • Gap analysis of PRO measures in paediatric migraine
  • Generation of evidence for the content validity of instruments assessing motor weakness in hemiplegic migraine
  • Review of concussion PROs relating to migraine

Miscarriage

  • Meta-analysis of a treatment for recurrent miscarriage

Mitochondrial disease

  • PRO questionnaire development in mitochondrial myopathy
  • Cognitive debriefing interviews for the Primary Mitochondrial Disease (PMD) Symptom Assessment Questionnaire

Mucopolysaccharidosis

  • Understanding the experience of the mucopolysaccharidosis I (MPS I) patient to improve outcome assessments: evidence from the literature and treatment experts
  • Cognitive debriefing interviews on the Mucopolysaccharidosis Health Assessment Questionnaire (MPS-HAQ)
  • Evaluating the MPS-HAQ for use in patient registries to support EMA regulatory commitments

Multinodal goiter

  • PRO endpoint review in multinodal goiter
  • Cognitive debriefing on quality of life in multinodal goiter
  • Qualitative data analysis and FDA support in multinodal goiter

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