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.

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
  • 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
  • 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
  • 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

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

Down’s syndrome

  • Development of a COA strategy for Down’s syndrome in adults and children
  • Clinical meaningfulness of scores on the Vineland Adaptive Behaviour Scale (VABS-II), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Clinician Global Impression (CGI) in Down’s syndrome
  • Strategic literature review to identify COA instruments to assess the concept of independence in Down’s syndrome
  • Qualitative interviews and development of a COA strategy for Down’s syndrome in adults and children
  • Subgroup analysis by chronological age of individuals with Down’s syndrome

Dry eye

  • Healthcare resource costing study for dry eye disease in the UK
  • Development of a user manual on the Impact of Dry Eye in Everyday Life (IDEEL) using FDA guidelines
  • Revision of a manuscript on an IDEEL questionnaire for submission
  • Poster documenting development of the IDEEL
  • Consultation on composite endpoints for dry eye
  • Development of PRO for dry eye
  • Validation of a PRO for dry eye
  • Topline literature review to confirm information relating to three COAs for dry eye

Duchenne muscular dystrophy

  • Gap analysis of clinical outcome assessments and natural history of duchenne muscular dystrophy
  • Qualitative interviews with patients, caregivers and clinicians to define a clinician global impression of change item for duchenne muscular dystrophy

Duchenne muscular dystrophy

  • Gap analysis of clinical outcome assessments and natural history of duchenne muscular dystrophy
  • Qualitative interviews with patients, caregivers and clinicians to define a clinician global impression of change item for duchenne muscular dystrophy