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.

Prostatic hyperplasia

  • Early economic model in benign prostatic hyperplasia
  • PRO literature review in benign prostatic hyperplasia

Pruritus

  • Strategic review and recommendations for paediatric endpoints to assess pruritis in colostatic liver disease
  • Translation and linguistic validation of the numerical rating scale (NRS) in pruritus and cognitive debriefing of an ePRO diary
  • COA consulting support for a numeric rating scale in pruritus

Psoriasis

  • Development of a payer value proposition and materials in psoriasis
  • NICE submissions for a new biologic for the treatment of moderate to severe psoriasis in the UK
  • Systematic literature review of quality of life in psoriasis
  • Manuscript on a literature review of quality of life in psoriasis
  • Literature review and stakeholder interviews on payer decision drivers in psoriasis
  • Update a to core value dossier in psoriasis
  • UK value story for a new treatment in psoriasis vulgaris
  • Competitor review deck and objection handler in psoriasis
  • Mini competitor review for a value proposition in psoriasis
  • Budget impact model for a new treatment in psoriasis vulgaris
  • Systematic literature review and network meta-analysis update in psoriasis
  • Indirect treatment comparison for a 2nd round response to PBAC for a psoriasis treatment
  • Supplementary analyses and reporting for the psoriasis network meta-analysis
  • Payer evidence dossier for a new psoriasis treatment
  • Payer dossier on psoriasis
  • Payer dossier for paediatric psoriasis
  • Mini value dossier on paediatric psoriasis
  • Repurposing a slide deck for a payer value proposition in paediatric psoriasis
  • Core value dossier/payer value deck updates and competitor value differentiation slide sets on psoriasis
  • Core value dossier, payer value proposition and objection handler in psoriasis
  • Update to a value proposition slide deck for a treatment in psoriasis
  • Core value dossier update in psoriasis
  • Systematic literature review and network analysis in psoriasis
  • Early global value dossiers for a new monoclonal antibody in psoriasis
  • Total Brand FAQ deck and Total Brand Workshop in psoriasis
  • Global value dossiers and budget impact models for biosimilars in psoriasis
  • Systematic literature review in psoriasis – update for Poland
  • Targeted literature review in psoriatic arthritis patients with concomitant moderate to severe psoriasis
  • Country adaptation of a European payer dossier in psoriasis to Latin America and Spain
  • Core value dossier, value deck, literature review and objection handler in psoriasis
  • Global value dossier update in paediatric psoriasis
  • Structured literature review and value dossier updates in a biosimilar for psoriasis and paediatric plaque psoriasis
  • Budget impact model on the costs of treating psoriasis
  • Payer value deck for a biosimilar in psoriasis and paediatric plaque psoriasis
  • Psychometric testing of self-assessment of a psoriasis symptoms questionnaire
  • Psychometric validation of a psoriasis tool
  • Analysis and Abstract Development on a cumulative life course impairment (CLCI) in psoriasis
  • CLCI marketing and clinical data analysis of a psoriasis tool
  • Development of a PRO to assess sexual dysfunction in psoriasis
  • Development of a poster to describe the development of a PRO to assess the impacts of psoriasis
  • Scientific communications on the development of a PRO to assess sexual dysfunction in psoriasis
  • Development of psoriasis symptoms and treatment satisfaction measures
  • Patient preference study in plaque psoriasis
  • Strategic PRO review in psoriasis
  • Interviews with patient focus groups in psoriasis
  • Database analysis and publications in psoriasis treatment
  • Review of PROs and preparation and writing of a PRO briefing document for the FDA on the treatment of psoriasis
  • Review of a briefing document prepared for submission to the FDA in support of labelling claims in psoriasis
  • Briefing book support and psychometric evaluation of the Self-Assessment for Psoriasis Symptoms (SAPS)
  • International economic evaluation of a treatment for moderate to severe chronic plaque psoriasis
  • Measurement strategy in chronic plaque psoriasis
  • Support in development and analyses of a patient support programme in plaque psoriasis
  • Manuscript on Self-Assessment for Psoriasis Symptoms (SAPS) psychometric publications

Qualitative interview methods

Addiction

  • Interviews and Rasch analysis in opioid addiction

Allergic conditions

  • Development of a COA strategy to measure treatment side effects for peanut allergy treatments

Autoimmune diseases

  • Assessing utility for flares in systemic lupus erythematosus in the UK, France, Spain, Australia and Canada, including training and managing local interviewing agencies and providing support to local teams
  • Key opinion leader contracting and additional interviews for assessing utility in various severities of flares in systemic lupus erythematosus

Cardiovascular disease

  • PRO claims for pulmonary arterial hypertension – endpoint review, regulatory support for the FDA and EMEA and qualitative patient interviews
  • Key opinion leader interviews on neurogenic orthostatic hypotension

Central nervous system/neurology

  • 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
  • Interview study to understand the experience of walking pain among patients with diabetic peripheral neuropathy
  • Interviews on the development of a composite trial endpoint for Dravet’s syndrome
  • Development of a conceptual framework and endpoint model in insomnia, plus qualitative patient interviews to confirm the validity of the conceptual framework and the psychometric validation of the final conceptual framework
  • Qualitative interviews in chronic migraine headaches
  • Regulatory consulting to support development of a structured diagnostic interview and severity scale in paediatric RLS, along with development of two manuscripts to document the development and validation process
  • Development and validation of a diagnostic interview and severity scale for paediatric RLS
  • Endpoint review and strategic recommendations on the application of the Zarit Burden Interview (ZBI) to assess caregiver burden in schizophrenia

Dermatology

  • Concept elicitation interviews in acne vulgaris to reach saturation
  • Analysis, reporting and patient interviews PRO in acne vulgaris
  • Patient interviews for the development of alopecia-related PRO measures
  • Qualitative interviews to evaluate the psychological impact of the brow satisfaction questionnaire and to validate in a post-chemotherapy population
  • Qualitative interviews to support the concept of psychological impact on the facial line outcomes questionnaire
  • Qualitative analysis of patient interviews to identify how subjects describe the severity of crow’s feet
  • Interviews with patient focus groups in psoriasis
  • Patient interviews and reporting on a photoguide in rosacea
  • Consulting on patient qualitative insight blogs with follow-up interviews to explore wound scar healing
  • Development of PRO and ClinRO instruments for alopecia totalis and alopecia universalis

Endocrinology and metabolic diseases

  • Patient interviews in type 2 diabetes for development of a new PRO measure
  • Interviews with patients with diabetes-induced edema in the USA
  • Interview study to understand the experience of walking pain among patients with diabetic peripheral neuropathy
  • Outcomes interviews in phenylketonuria, resource use and impact on patients
  • Development and validation of a patient-reported outcome measure for non-alcoholic steatohepatitis

Gastrointestinal diseases

  • In-depth interviews, instrument development and cognitive debriefing related to measurement of opioid-induced constipation
  • Patient interviews to assess content validity of an instrument for use in opioid-induced constipation
  • Qualitative interviews to develop a symptom measure in adult patients with eosinophilic esophagitis
  • Sub-group analysis of gastroparesis patients interviewed in exploratory phase, Rasch analysis and PCA on a 5 item scale
  • Patient interviews and qualitative work on IBS
  • Independent analysis, evidence saturation and report on 30 interviews in IBS-C
  • Long term safety study and participation interviews in chronic constipation and IBS-C
  • Manuscript based on the findings of the exit interview study of patients taking a treatment for IBS-C within a long term safety study
  • Interviews with clinicians to understand diagnoses of paediatric IBS-C and CC
  • Language validation interview for an ascites impact questionnaire
  • Support with interviews in paediatric vomiting

Genetic disorders

  • Qualitative interviews and development of a COA strategy for Down’s syndrome in adults and children
  • Patient interviews to support a PRO submission package in hereditary angioedema
  • Patient interviews for the face and content validation of the Patient Global Impression in hereditary angioedema
  • Endpoint review and caregiver interviews in Sanfilippo syndrome
  • Concept elicitation interviews in Barth Syndrome patients
  • Qualitative concept elicitation and case studies documenting the disease progression of Barth Syndrome

Haematology

  • Exit interviews to assess the impact of infusion frequency in haemophilia A
  • IRB submission for haemophilia patient interviews
  • Clinician and patient interviews for a PRO in iron overload
  • Caregiver interviews to support content validity of an ObsRO in a paediatric population with severe aplastic anaemia (SAA) and chronic immune thrombocytopenic purpura (CITP)
  • Qualitative interviews with patients with myelodysplastic syndrome

Immunology

  • Cognitive Debriefing of the Eosinophilic Esophagitis Activity Index (EEsAI)

Infectious diseases

  • Concept elicitation and cognitive debriefing interviews with hepatitis C patients in multiple countries
  • Consulting on the development of a PRO strategy for international HIV trials with interviews in the US and Puerto Rico

Men’s health

  • Patient interviews to support the development of an FDA dossier on an erection hardness score questionnaire

Musculoskeletal diseases

  • Patient interviews on rheumatoid arthritis
  • Pilot testing interviews on fibromyalgia fatigue
  • Patient interviews and manuscript on the development of a PRO strategy to support labelling claims in gout
  • Focus group interviews with patients with chronic low back pain
  • Qualitative exit interviews to assess the patient experience of treatment and clinical trial participation among patients with chronic low back pain and osteoarthritis

Nephrology

  • Qualitative interviews, conceptual model and strategic consulting on autosomal dominant polycystic kidney disease (ADPKD)

Oncology

  • Patient interviews to investigate side effects of breast cancer treatment
  • Qualitative interviews to assess equivalence of paper and electronically administered questionnaires in head and neck cancer
  • Qualitative interviews to understand the impact of non-small cell lung cancer (NSCLC) on quality of life
  • Qualitative interviews to understand the impact of NSCLC on caregivers and family members
  • Exploratory qualitative interviews in NSCLC patients to assess progression-free survival
  • Patient interviews in lung cancer
  • Strategic PRO endpoint support, gap analysis and patient interviews in a biological therapy treatment for non-Hodgkin’s lymphoma
  • Pilot patient interviews in melanoma
  • Pre-screen interviews for the relative resource utilization of intravenous and subcutaneous drug administration in metastatic bone disease
  • Patient interviews in multiple myeloma and development of a poster on the results
  • Burden of relapse in multiple myeloma: communicating the findings from patient and physician interviews in the EU5
  • Expert interviews and amendment project to heath economic model for a treatment for breakthrough cancer pain

Ophthalmology

  • Patient interviews on glaucoma treatment characteristics and outcomes: unmet patient needs & value drivers
  • Brief literature reviews and patient interviews to inform development of PRO strategies in retinitis pigmentosa – stages 1, 2 and 3
  • Exploratory interviews to confirm the benefits of an experimental treatment in retinitis pigmentosis
  • Analysis and reporting on completed interviews about eyelid swelling

Respiratory diseases

  • Exit interviews and evaluation of the psychometric properties of the Asthma Daily Symptom Diary (ADSD) in severe asthma
  • Exit interviews to provide additional evidence of content validity for a quantitative study in asthma
  • Clinical trial exit interviews to characterise patients’ experience and treatment benefit in patients with activated phosphoinositide 3-kinase delta syndrome (APDS)
  • Content validation of a COA strategy for respiratory syncytial virus (RSV) and influenza in the elderly or in those with respiratory compromise
  • Exit interviews with caregivers and clinicians in a prospective study to assess the Paediatric Respiratory Syncytial Virus (RSV) Electronic Severity and Outcome Rating System (PRESORS)
  • Exit interviews on a connected inhaler system for asthma

Women’s health

  • Patient interviews and analysis/report on the Female Sexual Desire Profile (FSDP) and Female Sexual Encounter Profile (FSEP)
  • Qualitative research to assess the content validity of the dysmenorrhea daily diary (DysDD) in patients with endometriosis

Rabies

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

Regulatory briefing documents and PRO dossiers

  • Allergic rhinitis
  • Chronic obstructive pulmonary disease
  • Chronic pain
  • Constipation predominant irritable bowel syndrome
  • Crohn’s disease
  • End stage renal disease patients on haemodialysis
  • Epilepsy
  • Epoietin alfa in chronic kidney disease
  • Erythematous rosacea
  • Eyelash satisfaction questionnaire
  • Facial wrinkling
  • Functional digestive disorders (post-prandial distress syndrome)
  • Glioblastoma
  • Heart failure
  • Hereditary angioedema
  • Hereditary hemochromatosis
  • Hunter’s syndrome
  • Hypogonadism
  • Major depressive disorder
  • Multiple sclerosis
  • Pre-menstrual dysphoric disorder
  • Psoriasis
  • Retinal vein occlusion
  • Rheumatoid arthritis
  • Spinal cord injury
  • Smoking cessation
  • Ulcerative colitis

Respiratory syncytial virus

  • Core value dossier for a treatment for respiratory syncytial virus
  • Core value dossier update in respiratory syncytial virus prophylaxis to support the roll-out of a new liquid formation
  • Value dossier update on respiratory syncytial virus
  • Payer objection handlers to support treatment in secondary hyperparathyroidism (SHPT) and respiratory syncytial virus
  • Economic evaluation of a treatment for respiratory syncytial virus
  • Value communication support in acute otitis media associated with respiratory syncytial virus (RSV)
  • Observational study and claims analysis of respiratory distress in infants with respiratory syncytial virus
  • Development of an evidence package for a COA strategy for paediatric respiratory syncytial virus
  • Content validation of a COA strategy for paediatric respiratory syncytial virus
  • Exit interviews with caregivers and clinicians in a prospective study to assess the Paediatric Respiratory Syncytial Virus Electronic Severity and Outcome Rating System (PRESORS)
  • Content validation of a COA strategy for respiratory synctial virus in the elderly or in those with respiratory compromise

Restless leg syndrome

  • Development of a value slide set in restless leg syndrome (RLS)
  • Global value dossier and e-v@luate platform development in RLS
  • PRO and Health Economics (HE) consulting on global health outcomes in RLS
  • Development of a sleep measure for a labelling claim in RLS
  • Linguistic validation management of the Restless Leg Syndrome Next Day Impact (RLS-NDI)
  • Synopsis of conclusions for diagnosis of paediatric RLS
  • Regulatory consulting to support development of a structured diagnostic interview and severity scale in paediatric RLS, along with development of two manuscripts to document the development and validation process
  • Abstracts and presentations on the results from an independent study of RLS
  • Psychometric validation of a two-factor solution for RLS
  • Analysis of RLS sub-scales
  • Manuscript on RLS, sleep and cognition
  • Consultation on the development of questionnaires for RLS
  • Expert meeting on paediatric RLS
  • Development and validation of a diagnostic interview and severity scale for paediatric RLS
  • Validation of the Medical Outcomes Study (MOS) sleep questionnaire using pooled trial data from RLS trials
  • Validation of the Restless Leg Syndrome Rating Scale (RLS-RS) and Restless Leg Syndrome Quality of Life (RLS QoL) questionnaire

Retinal vein occlusion

  • Content validity of a visual function questionnaire with 10 retinal vein occlusion patients
  • FDA claim strategy and endpoint review for a visual function questionnaire in retinal vein occlusion

Retinitis pigmentosis

  • Utility study feasibility assessment in retinitis pigmentosis
  • Brief literature reviews and patient interviews to inform development of PRO strategies in retinitis pigmentosa – stages 1, 2 and 3
  • Exploratory interviews to confirm the benefits of an experimental treatment in retinitis pigmentosis
  • Development and validation of a PRO instrument in retinitis pigmentosa

Rhinoconjunctivitis and rhinitis

  • Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Work Productivity and Activity Impairment (WPAI) questionnaire trial in Japan
  • Psychometric validation of the RQLQ in Japanese
  • Manuscript on the validation of the RQLQ
  • Development of a paediatric rhinitis symptom assessment tool
  • Review of PROs and development of a patient-reported screening tool in allergic rhinitis/rhinoconjunctivitis

Rosacea

  • Development of a symptom, impact and satisfaction measure in rosacea
  • Testing PRO measures in electronic devices for rosacea
  • Development of a photonumeric guide for rosacea
  • Patient interviews and reporting on a photoguide in rosacea
  • Cognitive photoguide interviews in rosacea
  • SAP development for phase II psych testing in rosacea
  • Simultaneous development and regulatory documentation of two PRO questionnaires to assess the signs and symptoms of interdigital tinea pedis and rosacea
  • Development of a PRO dossier for the Subject Self-Assessment of Erythema Scale (SSA) for erythematous rosacea
  • Linguistic validation and translation of the PAPSS, PAPI, PGIS, PGI-C, PGI-TS and PGI-SE in rosacea

Rotavirus

  • Payer value deck in adult rotavirus gastroenteritis
  • Payer material development for vaccines in rotavirus gastroenteritis
  • Payer value deck in adult rotavirus gastroenteritis (pneumococcal conjugate vaccination)
  • Payer value deck on the humanistic burden of rotavirus
  • e-v@luate platform on a vaccine for rotavirus
  • Manuscript, economic model and literature review on the burden of rotavirus and the impact of vaccination on health care utilization in Europe

Salivary cancer

  • Budget impact models in salivary cancer
  • Cost calculator to reflect change in patient estimation approach in salival cancer

Sanfilippo syndrome

  • Payer research into a new treatment for mucopolysaccharidosis III (San Filippo syndrome)
  • Preliminary consulting on endpoints in San Filippo syndrome
  • Endpoint review and caregiver interviews in San Filippo syndrome
  • Participation in a meeting to provide consultation on a paediatric PRO in San Filippo syndrome
  • Strategic PRO and ObsRO analysis of a San Filippo natural history study database

Sarcoma

  • Payer value slide deck on sarcoma
  • Payer frequently asked questions on sarcoma
  • Affiliate market access tools implementation guide in sarcoma

Scarring

  • Psychometric validation and field study on the Patient-Reported Scar Evaluation Questionnaire (PR-SEQ)
  • Regulatory consulting and attendance at an FDA meeting for the PR-SEQ
  • Translation and linguistic validation of the PR-SEQ
  • Consulting on patient qualitative insight blogs with follow-up interviews to explore wound scar healing
  • Development of a photonumeric guide and PRO measure of surgical scarring
  • Sub-group analysis of scar data

Schizophrenia

  • Core value dossier for treatment of schizophrenia to support local payer discussions
  • Update of a value dossier in schizophrenia
  • Identification and determination of the evidence base for a drug used to treat schizophrenia and the value drivers to support continued (and increased) patient access
  • Literature review on the burden of negative symptoms in schizophrenia
  • Content validation of the Readiness for Work questionnaire in schizophrenia
  • Literature review of ClinROs used to measure negative symptoms of schizophrenia
  • Database analysis for adherence and re-hospitalizations in schizophrenia patients
  • Literature research and review of the emotional components of schizophrenia
  • Review of the cognitive components of schizophrenia
  • Comprehensive literature review on cognitive impairment in schizophrenia
  • Development of a manuscript on the humanistic burden of cognitive impairment associated with schizophrenia
  • Translation and validation of the schizophrenia cognitive functioning scale into Japanese
  • Endpoint review and strategic recommendations on the application of the Zarit Burden Interview (ZBI) to assess caregiver burden in schizophrenia
  • Preparation of a conference abstract and poster on schizophrenia
  • Cognitive debriefing and usability testing of ePRO measures to be used in a schizophrenia registry study
  • Workshop moderator for roundtable discussions regarding the clinical relevance of negative symptoms in schizophrenia
  • Development and validation of a clinical decision-making tool in schizophrenia
  • Development of an endpoint model, training and recommendations for endpoint support in schizophrenia
  • Composition of a PASS report on schizophrenia, including a review of local physician monitoring guidelines
  • Validation of the Caregiver Strain Questionnaire in schizophrenia

Scottish Medicines Consortium (SMC – UK)

  • Anthracycline extravasation
  • Breakthrough cancer pain
  • Breast cancer
  • Diabetes (type 2)
  • Epilepsy
  • Gastric cancer
  • Head and neck cancer
  • Hepatitis B
  • HIV
  • Homocystinuria
  • Infertility
  • Iron overload
  • Kidney failure
  • Lung cancer (non-small cell)
  • Parkinson’s disease
  • Psoriatic arthritis
  • Secondary hyperparathyroidism in end stage renal disease
  • Ulcerative colitis

Severe aplastic anaemia

  • Caregiver interviews to support content validity of an ObsRO in a paediatric population with severe aplastic anemia
  • Palatability and acceptability of a treatment in paediatric populations with severe aplastic anemia
  • Development of a scoring algorithm for an acceptability and palatability questionnaire in severe aplastic anemia