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.

Cervical cancer

  • Budget impact model in 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
  • 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

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
  • 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
  • Clinical trial synopsis consulting for a phase III clinical program in dementia

Dengue disease

  • 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
  • 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
  • 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
  • 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 anaylsis on GLP1 receptor agonists in type 2 diabetes
  • e-v@luate EVIDENCE platform development for 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

Diabetes-related conditions/complications

Diabetic neuropathy

  • Linguistic validation of the Norfolk Quality of Life (QoL) questionnaire in diabetic neuropathy
  • Competitive analysis and burden of illness in diabetic peripheral neuropathy
  • Literature review of PROs and endpoints of pain in peripheral diabetic neuropathy
  • PRO assessment in diabetic peripheral neuropathy
  • Validation study of the modified version of the Brief Pain Inventory – Short Form (mBPI-SF), MOS-S and 3 single item questions in diabetic peripheral neuropathy
  • Gap analysis and strategic recommendation for PRO and market access studies in diabetic peripheral neuropathy
  • Consultancy on the validity of the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale for use in painful diabetic neuropathy patients
  • Interview study to understand the experience of walking pain among patients with diabetic peripheral neuropathy
  • Analysis of diabetic neuropathy

Retinopathy

  • Value messages and objection handlers for anti-vascular endothelial growth factor therapy (anti-VEGF) treatment in diabetic retinopathy and retinopathy of prematurity

Hypoglycaemia

  • Scientific communication on the prevalence and cost of severe hypoglycaemic events in Denmark
  • Slide deck on hypoglycaemia in diabetes
  • Study poster on Hypoglycaemia in Insulin Treated (HIT) patients
  • Manuscripts reporting the findings of the HIT Study on hypoglycaemia in diabetes
  • Manuscript reporting hypoglycaemia data for the HIT survey in the Netherlands
  • Three manuscripts for treatment of hypoglycaemia
  • Interactive slide deck presentation of hypoglycaemia study results
  • Abstract and manuscript reporting analyses from a hypoglycaemia study in the UK
  • Two manuscripts reporting specific country analyses from a hypoglycaemia study (Austrian and Finnish)
  • Manuscript reporting specific country analyses from a hypoglycaemia study (Denmark)
  • Scientific communication and presentation of data from the cross EU HIT study in hypoglycaemia

Diabetic macular edema

  • Rapid payer research to inform investment decisions in diabetic macular edema
  • Cost-effectiveness model to inform investment decisions in diabetic macular edema
  • Content validation of a visual function questionnaire in diabetic macular edema and retinal vein occlusion
  • FDA claim strategy and endpoint review for a visual function questionnaire in diabetic macular edema (DME) and retinal vein occlusion (RVO)
  • Review of PRO measures in diabetic macular edema
  • Interviews with patients with diabetes-induced edema in the USA

Diabetic foot infections

  • Diabetic foot ulcer support for FDA meetings
  • Psychometric validation of the Diabetic Foot Ulcer Scale (and Short Form) and the Short Form Health Survey (SF-36)
  • Cost effectiveness analysis model for Portugal on a treatment for bacterial diabetic foot infections
  • PRO strategy of a HRQoL claim for diabetic foot ulcers in vascular endothelial growth factor (VEGF)

Gastroparesis

  • Review of protocol on a phase II study of subjects with severe gastroparesis due to diabetes mellitus
  • Cognitive debriefing of a symptom measure of gastroparesis in diabetics and standalone validation study

Diabetic neuropathy

  • Linguistic validation of the Norfolk Quality of Life (QoL) questionnaire in diabetic neuropathy
  • Competitive analysis and burden of illness in diabetic peripheral neuropathy
  • Literature review of PROs and endpoints of pain in peripheral diabetic neuropathy
  • PRO assessment in diabetic peripheral neuropathy
  • Validation study of the modified version of the Brief Pain Inventory – Short Form (mBPI-SF), MOS-S and 3 single item questions in diabetic peripheral neuropathy
  • Gap analysis and strategic recommendation for PRO and market access studies in diabetic peripheral neuropathy
  • Consultancy on the validity of the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) pain scale for use in painful diabetic neuropathy patients
  • Interview study to understand the experience of walking pain among patients with diabetic peripheral neuropathy
  • Analysis of diabetic neuropathy

Diptheria

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