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.

Cerebral palsy

Gap analysis in juvenile cerebral palsy

Cervical cancer

Budget impact model in cervical cancer
Manuscript on cervical cancer
Literature review on cervical cancer
Development of a PRO strategy in cervical cancer and HPV
Summary report, top-up literature review, meta-analysis, editorial board and manuscripts on HPV infection and cervical cancer

Cervical dystonia

Validation and reliability of the Pictorial Spasmodic Torticollis Rating Scale (P-STRS) in cervical dystonia
Development of a screening tool in cervical dystonia (Delphi panel) and validate using registry
Validation of a screening tool in cervical dystonia
Measurement strategy in cervical dystonia
Content validity of global questionnaires in cervical dystonia

Chronic obstructive pulmonary disease (COPD)

Value proposition for a new metered dose inhaler to treat chronic obstructive pulmonary disease (COPD)
External expert assessment of a drug for COPD
Development of a global market access value pack to support regional/local access teams and HTA submissions in COPD
Value pack (objection handler and budget impact/cost minimisation model) in COPD
Conference abstract and poster development on COPD
Manuscript on the budget impact of a new treatment in COPD
Updates to critical handling error manuscript in chronic obstructive pulmonary disease (COPD)
Structured literature review and qualitative interviews with payers/HCPs on a device for COPD
Value messaging and HE training support in COPD
Protocol development support for a conjoint patient preference study in COPD
PRO strategy support for an inhaler treatment for COPD
Literature review, FDA briefing document and FDA meeting related to the development of an ePRO for well controlled days in COPD
Targeted literature review of PRO measures in frequently exacerbating COPD patients
Literature review and research around treatment experiences of patients with COPD
Exit interviews to explore patient disease burden, treatment satisfaction and clinical trial participation in muscle wasting associated with COPD
Development and delivery of a manuscript on the results from a trial in COPD
Translation and validation of the chronic obstructive pulmonary disease population screener (COPD-PS) in Japan
Poster presentation on the validation of the COPD-PS in Japan
Manuscript on the validation of the COPD-PS in Japan
Poster on the development of the Cough and Sputum Assessment Questionnaire (CASA-Q) in COPD
Development of a user manual for the cough and sputum assessment questionnaire
Validation of the CASA-Q trial
Cross-team review of a CASA-Q PRO dossier in COPD for submission to the FDA
FDA support for the CASA-Q in COPD
Support at investigator meetings for the CASA-Q
Psychometric validation of the Shortness of Breath Questionnaire in COPD
Validation of a questionnaire for assessing control status of patients with COPD
Development of a dyspnoea scale in COPD
Development and validation of a satisfaction questionnaire in COPD
Development of a symptom diary in COPD
Validation of a patient diary to assess symptoms of COPD
Development of a poster and validation of a questionnaire in COPD
Development and validation of an ePRO in COPD
Mixed treatment comparison between competing interventions for COPD
Association between exacerbations, a respiratory questionnaire and the use of rescue medication in COPD
Network meta-analysis of two treatments for COPD
Network meta-analysis of one drug versus fixed dose combinations in COPD
Network meta-analysis of competing interventions in the management of COPD
Conference presentation on a network meta-analysis of a treatment for COPD
Development of a preference-based instrument specific to COPD
Validation of a patient diary for evaluating acute exacerbation of chronic obstructive pulmonary disease (AECOPD)

Clostridium difficile

Pre-budget impact analysis and economic advice for personalized medicine: approaches to diagnose and control clostridium difficile infections

College voor zorgverzekeringen (CVZ – Netherlands)

Cost-effectiveness assessment for drug to be listed on the hospital ‘expensive drug list’
Cost-effectiveness assessment for an orphan drug
Diabetes (type 1)
Diaper dermatitis complicated by candidiasis in infants
Heart failure
Herpes zoster vaccine
HPV vaccine
Metabolic syndrome
Metastatic soft-tissue sarcoma

Colorectal cancer

Adaptation of a multi-indication value-based pricing model in colorectal cancer in China
Project management of a mixed treatment analysis on colorectal cancer
Update to a payer value slide deck in metastatic colorectal cancer
Value-based model in colorectal cancer
Payer communications strategy and tools in colorectal cancer
Reimbursement dossiers in subgroups of colorectal cancer
Mini literature review in metastatic colorectal cancer
Literature review and payer communication tools in metastatic colorectal cancer
Translation to support development of a value dossier and budget impact model in capsule endoscopy for colonoscopy
Global model update and country adaptations for a multi-indication value-based pricing (VBP) model on colorectal cancer
Update to a Belgian value-based pricing model in colorectal cancer
Reimbursement scenario analysis in oncology for 11 country adaptations and inclusion of colorectal cancer
Structured literature review in metastatic colorectal cancer
Communication tool to support a budget impact model in metastatic colorectal cancer
Development of one-pager briefing documents on metastatic colorectal cancer
PRO assessment on the neurotoxicity of a treatment for advanced colorectal cancer
Clinical trial analyses to support HRQoL in recurrent and metastatic microsatellite instability high colorectal cancer
White Paper on continuous infusion in colorectal cancer
Development of cost arguments and brochure development in colorectal cancer
Network meta-analysis on the efficacy of treatment for metastatic colorectal cancer
Recommendations on the economic impact of a treatment for metastatic colorectal cancer
Network meta-analysis of a treatment versus other biologics for metastatic colorectal cancer in 1st line, 2nd line and multiple line settings
Web-based survey to understand patient-preference and satisfaction in advanced colorectal cancer

Constipation

Market access consultancy in the treatment of chronic idiopathic constipation
Cognitive debriefing interviews for a paediatric constipation symptom diary
Development of a PRO strategy for paediatric chronic constipation
Development of PRO instruments assessing symptoms and health-related quality of life for paediatric patients with chronic constipation
Development of a primary endpoint to assess quality of life in paediatric constipation
Providing support in the design and set up of a paediatric functional constipation dose ranging study, updating the eCOA and incorporation of the eCOA into the trial, and support in performing psychometric validation using the trial data
Face and content validation of an e-diary to assess opioid-induced constipation and other gastrointestinal side effects in chronic non-cancer pain
Planning and execution of an advisory board to obtain feedback on the PRO strategy and plans for the phase III program for a treatment for opioid-induced constipation
Patient interviews to assess content validity of an instrument for use in opioid-induced constipation
Cognitive debriefing of 7-day recall period for the Patient Assessment of Constipation, Quality of Life Questionnaire (PAC-QOL) and Patient Assessment of Constipation Symptoms (PAC-SYM) in opioid-induced constipation
PAC-SYM and analysis of a skin patch containing an opioid pain medication
Review of patient diaries and PRO questionnaires for evaluating constipation in opioid-treated non-cancer pain
In-depth interviews, instrument development and cognitive debriefing related to measurement of opioid-induced constipation
Validation of a patient e-diary to assess opioid-induced constipation
Consolidation of results on the development of a bowel function diary for opioid-induced constipation
Endpoint model, conceptual framework, cognitive debriefing interview, saturation point and report on opioid-induced constipation
Cognitive debriefing of a PRO measure of paediatric chronic constipation
Long term safety study and participation interviews in chronic constipation
Consultation on a project on chronic constipation
Manuscript based on a literature review in paediatric constipation
Literature review on chronic constipation
FDA meeting on chronic constipation
Interviews with clinicians to understand diagnoses of paediatric chronic constipation

Contraception

PRO endpoint review in contraceptives
Manuscript publication on a monthly contraceptive device
Development of a PRO strategy in oral contraceptives and gynaecological therapies
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
Linguistic validation of the EVAPIL-R questionnaire on tolerability of oral contraceptives
Expert panel meeting on an oral contraceptive

Cough and cold

Literature review on cough and cold over-the-counter medications
Strategy meeting on colds and coughs with the Consumer Healthcare Products Association
Communication support to develop a PRO instrument to measure multiple cold symptoms in children
Research to support the development of a PRO strategy for use in paediatric cough and cold
Development and validation of an ePRO instrument to assess symptoms associated with paediatric cold
Validation of a 3 item composite measure to assess the symptoms of chronic rhinisitus
Consulting for an FDA meeting and requirements regarding the Total Sinus Symptom Score (TSSS) as a primary endpoint in chronic rhinisitus
Cognitive debrief of cold symptom PRO questions in paediatric patients
Development and content validity testing of PRO questions developed to measure additional paediatric cold symptoms
Pilot testing and validation of a PRO instrument to measure multiple cold symptoms in children

COVID-19

Estimation of return on investment from vaccinating the adult population against COVID-19
Anti-viral systematic literature reviews and dossiers on COVID-19

Critical limb ischaemia

Market access and HEOR launch support in critical limb ischaemia

Crohn’s disease

Early global value dossiers for a new monoclonal antibody in Crohn’s disease
Literature review and recommendations for Crohn’s disease
Payer objection/question responses in Crohn’s disease
Structured literature review and value dossier updates in a biosimilar for Crohn’s disease
Payer value deck for a biosimilar in Crohn’s disease and paediatric Crohn’s disease
White paper on PROs in Crohn’s disease
FDA briefing document on Crohn’s disease
Advisory board on a treatment for Crohn’s disease
Development and implementation of a plan to deliver economic and outcomes evidence to support commercialisation of a treatment for Crohn’s disease in key markets
US database analysis to support a pharmacoeconomic model in Crohn’s disease in the US
PRO review in Crohn’s disease
PRO gap analysis and initial PRO dossier development in Crohn’s disease
Support in development and analyses of a patient support programme in Crohn’s disease

Cushing’s disease

Input into PRO analyses for Cushing’s disease
Consultancy support for a clinical trial statistical analysis plan (SAP) in Cushing’s disease
Publication support and consultancy associated with patient-reported outcomes data for a trial in patients with Cushing’s disease
Consultancy and support associated with proposed analysis, communication and regulatory submission of patient-reported outcomes data for a trial in patients with Cushing’s disease

Cystic fibrosis

FDA PRO consulting for cystic fibrosis
Gap analysis and strategic recommendations for the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Model of cystic fibrosis disease progression

Dementia

Linguistic validation of the Neuropsychiatric Inventory (NPI) in dementia
Structured literature review in lewy body dementia
Network meta-analysis in dementia with lewy bodies
Manuscript on dementia with lewy bodies
Manuscript on a network meta-analysis in lewy body dementia
Clinical trial synopsis consulting for a phase III clinical program in dementia

Dengue disease

Payer slide deck to support HE models in dengue fever
Systematic literature reviews and global value dossiers in dengue fever
Development of a global value dossier in dengue fever
Systematic literature review of dengue fever in Mexico
Global value dossier on dengue fever
Finalization and validation of a PRO instrument for measurement of burden in Dengue disease

Depression

Development of an online therapy tool for depression along with a landscape analysis, structured and grey literature review, local language literature review, gap analysis, local language payer interviews and clinician interviews
Literature review and advisor feedback on the burden of illness, clinical and economic outcomes in US patients receiving adjunctive treatment for major depressive disorder
Literature review of the burden of depression in haemodialysis patients (in chronic kidney disease)
Literature review and sourcing of UK unit costs in depression
KOL interviews and Delphi method to estimate the direct health care costs of treating patients with treatment-resistant depression
Delphi method to estimate healthcare resource utilisation in major depressive disorder (MDD) with suicidal ideation
Delphi study cost estimates for healthcare resource utilisation in treatment-resistant depression
Delphi panel to estimate costs associated with major depressive disorder with suicide ideation (MDSI)
Delphi panel in depression
Manuscript and content validity of a PRO measure in major depressive disorder
Validation of the Children’s Depressions Rating Scale – Revised (CDRS-R) in Japan
Translation of the CDRS-R manual
PRO dossier on major depressive disorder for EMA submission
Development of an EMA technical document for PROs in depression
Instrument review and development of an EMA technical document to support patient-reported health-related quality of life labelling claims in depression
Communications on PRO clinical trial data and a literature review on depression
Development of a manuscript and presentation based on clinical trial PRO data in depression, primarily focused on interpretation of treatment
Validation and treatment effect analysis of the Sleep Impact Scale (SIS) in major depressive disorder
Review of PRO and CRO measures in severe depression
Selection of a PRO for depression in multiple sclerosis (MS)
Linguistic validation of a quality of life questionnaire on depression into UK English
Manuscript on validation and efficacy results in depression

Dermatitis

Mini value dossier in atopic dermatitis
Payer value materials in atopic dermatitis
Product value insight evaluation and strategy in atopic dermatitis
Core value dossier in atopic dermatitis
Analysis of the impact of chronic hand dermatitis on work productivity among healthcare workers in the UK
COA consulting support for a numeric rating scale in pruritus
Preparation of qualitative data in atopic dermatitis for FDA submission
Translation and linguistic validation of the numerical rating scale (NRS) in pruritus and cognitive debriefing of an ePRO diary
Development of a symptom-based PRO instrument in atopic dermatitis
Development of a PRO in adult atopic dermatitis
Psychometric evaluation of PROs in adult atopic dermatitis
COA development and content validity in atopic dermatitis
Development of a manuscript to communicate the patient experience of atopic dermatitis
Regulatory support in adolescent atopic dermatitis
Development and cognitive debriefing of a symptom diary for use in adults and adolescents with atopic dermatitis
Two abstracts to communicate the development of the atopic dermatitis adult and adolescent conceptual models
Usability testing of electronic handheld numeric rating scale (NRS) items in atopic dermatitis
Linguistic validation and translation of the PRE-FACE
Relationship between clinical outcome assessment (COAs) and objective measures in atopic dermatitis and sleep

Diabetes

Critical review of economic models, development of initial economic model structure in excel, development of budget impact model and publication in type 2 diabetes
Budget impact models for a biosimilar in type 1 and type 2 diabetes mellitus
Budget impact model for payer discussions in diabetes
Innovative budget impact model in type 2 diabetes
Communication on a formulary pack for medication in type 2 diabetes
NICE submission and SMC submission for an injectable drug for treatment of type 2 diabetes
SMC submission dossier for a treatment for type 2 diabetes
Payer strategy analysis of literature search results in type 2 diabetes
Payer value proposition and communication for a new remote patient monitoring platform in diabetes
Payer value deck in diabetes
Payer value slide deck for a biosimilar in diabetes
Payer communications in diabetes using data from the short form health survey (SF36)
Costing of pre-diabetes care in the US
Development of abstracts, posters and a manuscript on the critical review of economic models in diabetes
Global value dossier, AMCP and accompanying slide sets for an insulin biosimilar
Global value dossier updates, AMCP dossier updates and literature review in diabetes
Targeted literature review of the burden of type 2 diabetes mellitus
Systematic literature analysis on GLP1 receptor agonists in type 2 diabetes
Systematic literature analysis abstracts and white paper development on GLP1 receptor agonists in type 2 diabetes
Willingness to pay research in the UK, France and Germany in type 2 diabetes mellitus
e-v@luate EVIDENCE platform development for diabetes
e-v@luate platform for a payer value deck in type 2 diabetes
Manuscript on the barriers to intensification of insulin treatment in patients with type 2 diabetes in the Netherlands
Review of an Iranian manuscript on the cost of diabetes
Burden of disease in diabetes: Developing journal and conference publications based on market research data
Scientific communication for a time trade off (TTO) study in diabetes
Scientific communication of a Swedish cost-effectiveness analysis in diabetes
Manuscript on patient preference and willingness to pay in diabetes for South Africa
Scientific communications for a diabetes patient preference study in the UK
Scientific communications on a bolus insulin dosing study
Data collection for the use of long-acting insulin in the UK
Analysis and summary of outputs of client research with key opinion leaders to support reimbursement submissions and internal communications in diabetes mellitus (type 1 and 2)
Key opinion leader testimonials report and German data update in diabetes mellitus (type 1 and 2)
Key opinion leader testimonials poster in diabetes
Willingness to pay utility study in diabetes
Scientific communications for a willingness to pay study in diabetes
Frequently asked questions in diabetes
Posters regarding long acting insulin usage
Attendance at and strategic input into a diabetes workshop
Content validation of the paediatric quality of life questionnaire (PEDSQL) for type 1 diabetes mellitus
PRO selection, implementation, analysis and reporting on a low carbohydrate (CHO) trial in type 2 diabetes
Exploratory analyses and slide deck for a CHO trial in type 2 diabetes
PRO selection, implementation, analysis and reporting in type 2 diabetes mellitus
Gap analysis, endpoint model and FDA recommendations in type 2 diabetes
Recruitment and cognitive debriefing of three patients with type 2 diabetes
Indirect comparison of a treatment in type 2 diabetes
Systematic review of two treatments for type 2 diabetes
Validation of a hypoglycaemia questionnaire in type 2 diabetes
Development and validation of a PRO measure of hypoglycaemia, weight gain, tolerability and compliance in type 2 diabetes
Blind data review of a clinical trial in type 2 diabetes
Clinical trial analysis of a dose ranging study in type 2 diabetes mellitus
Analysis of PROs in two clinical trials in type 2 diabetes mellitus
Analysis of changes in HbA1C and health-related quality of life (HRQoL) in type 2 diabetes
Analysis of hypos versus no hypos in type 2 diabetes mellitus
Post-hoc analysis of clinical trial data: Linking clinical outcomes to PRO outcomes in type 2 diabetes mellitus
Biostats training and SAS program development for EQ-5D training in type 2 diabetes mellitus
Development of a dossier on the novel hypo instruments in type 2 diabetes mellitus
HEOR strategy support and study development in type 2 diabetes mellitus
Patient interviews in type 2 diabetes for development of a new PRO measure
Strategic literature review in type 2 diabetes
Literature review and development in type 2 diabetes
Consultation on a market research study on patient perceptions of pre-filled insulin pens
PRO analysis of a diabetes pre-post meal study
Gap analysis to identify the most responsive diabetes PRO measure for clinical trials
Validation of a revised symptom checklist in diabetes
Validation of the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) for diabetes in Japan
Cognitive debriefing on the perceptions about medications diabetes questionnaire (PAM-D)
Development of a manuscript on patient perceptions of prefilled insulin delivery devices
Database evaluation of costs and outcomes of diabetes treatment
Linguistic validation of the Diabetes Symptom Checklist-Revised (DSC-R) into UK English
Burden/cost of illness analysis of patient preference for once-weekly treatment in diabetes
Literature review examining the benefits of memory function on treatment adherence in diabetes
Development of a PRO strategy in diabetes
Evaluation of the potential for a satisfaction claim in an insulin product
Psychometric validation of a paediatric satisfaction instrument in diabetes
Analysis of a prevention clinical trial in diabetes
Strategic consulting and training in diabetes to support a client
Analysis of a patient qualitative assessment of a diabetic treatment after Ramadan
Analysis of clinical trial PRO data to assess patient-perceived and individualised benefit/risk of diabetic treatment