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.

Erectile dysfunction

Development of a symptom and QoL questionnaire on erectile dysfunction
Manuscript on the development of a questionnaire on treatment satisfaction in erectile dysfunction
International psychometric validation of the total symptom score (TSS) questionnaire in erectile dysfunction
Linguistic validation of the Rosenberg Self-Esteem Scale (RSES) questionnaire for erectile dysfunction into UK English
Linguistic validation and cognitive debrief of a self-esteem and relationship questionnaire for erectile dysfunction
FDA dossier for PRO instruments measuring the impact and symptoms of erectile dysfunction
Patient interviews to support the development of an FDA dossier on an erection hardness score questionnaire
Review of excel tables and a regulatory document for a treatment for management of erectile dysfunction

Esophogeal cancer

Payer value deck in esophogeal cancer
Burden of disease deck in esophogeal cancer
Response to payer questions in esophogeal cancer
Clinical trial analyses to support HRQoL in oesophageal cancer
Reimbursement scenario analysis in oncology for 11 country adaptations and inclusion of esophageal cancers

Excess sebum (oily skin)

Development and validation of a questionnaire to assess patient’s satisfaction with treatment for oily skin (excess sebum)
Validation of the Excess Sebum Treatment Satisfaction Scale and the Patient Reported Excess Sebum Co-primary efficacy endpoint
Focus group sessions presentation on excess sebum
Cognitive debriefing interviews in excess sebum
Consultation on a methods study to validate primary and secondary endpoint measures in excess sebum
Initial psychometric validation of an oily skin questionnaire
Face and content validation of the oily skin PRO instruments in adolescents

Eyelash/eyebrow satisfaction

Development of a poster and manuscript for the validation of an eyelash satisfaction questionnaire in China
Development of an EMA PRO dossier for an eyelash satisfaction questionnaire
Validation of the EEM and ESS in eyelash hypotrichosis
Item-level validation for a questionnaire in eyelash health and satisfaction
Validation of the eyelash satisfaction questionnaire in Japan
Development of a PRO dossier for the 9-item eyelash satisfaction questionnaire for Japan
Translation and validation of an eyelash questionnaire in China
Gap analysis of PROs for the use of a drug to grow darker and longer eyebrows
Content testing and adaptation of the eyelash satisfaction questionnaire (ESQ-9) for eyebrows
Cognitive interviews on the eyebrow satisfaction questionnaire
User manual and single item validation in eyebrow satisfaction
Qualitative interviews to evaluate the psychological impact of the brow satisfaction questionnaire and to validate in a post-chemotherapy population

Fabry’s disease

Global value dossier in the treatment of Fabry’s disease
Strategic literature review in Fabry’s disease
Development of a PRO questionnaire to assess gastrointestinal symptoms of Fabry’s disease
Survey administration in an observational study to evaluate gastrointestinal symptoms of Fabry’s disease
Strategic consultancy on a protocol for Fabry’s disease
Consulting agreement and communication in Fabry’s disease
Strategic consultancy in gastrointestinal symptoms of Fabry’s disease
Cognitive debriefing of the Gastrointestinal Symptom Rating Scale Diarrhoea Domain in patients with Fabry disease

Facial wrinkling

Development and validation of a PRO measure in facial lines
Validation plan and FDA regulatory support for the Facial Wrinkling Scale
Poster production for two PRO measures of facial wrinkling to be presented at a dermatological conference
Development of a manuscript to report the results of a PRO measure in facial wrinkling
Validation of a PRO measure of facial line satisfaction
Qualitative interviews to support the concept of psychological impact on the facial line outcomes questionnaire
Cognitive interviews in facial line satisfaction
Validation of the subject facial wrinkle scale in China
Psychometric evaluation of a PRO in facial lines
Support in securing advice on marketing claims not currently in the FDA-approved product label for a cosmetic treatment for facial lines
FDA dossier on a cosmetic treatment for facial lines
EMA dossier on a cosmetic treatment for facial lines
Content validation of the subject-rated facial wrinkle scale for forehead lines
Cognitive debriefing of a ClinRO in facial lines
Cognitive debriefing of a PRO in facial lines
Validation of a skin / wrinkling module
Validation of questionnaires for facial lines in Japan
Validation of questionnaires for facial lines in China
Consulting for ClinROs and PROs in facial lines and hyperhidrosis
Content validation of the facial wrinkle scale
Review of PRO endpoints for use of a topical botulinum toxin in trials for the treatment of crow’s feet
Development of a PRO briefing document to support the facial wrinkling scale in crow’s feet
Qualitative analysis of patient interviews to identify how subjects describe the severity of crow’s feet
Cognitive debriefing of a PRO in glabellar lines
Preparation of a payer briefing document for a treatment for glabellar facial lines
Abstract and poster development for a glabellar line clinical program
Support in the linguistic validation of glabellar facial line PROs
Publication strategy of PROs in glabellar lines
Psychometric evaluation and regulatory strategy of PROs in glabellar lines
Consulting agreement for trial preparation and PRO endpoints in canthal lines
Evaluation of psychological impact using the facial lines outcome-11 questionnaire in forehead lines, glabellar lines and upper facial lines
Prescription Drug Marketing Act (PMDA) PRO dossier for a cosmetic program

Female sexuality and sexual desire

Focus study on the Female Sexual Desire Profile (FSDP) and Female Sexual Encounter Profile (FSEP)
Patient interviews and analysis/report on the FSDP and FSEP
Measurement of the impact of quality of life on female sexuality
Critical review of PROs in female sexual disorder
PRO endpoint review for a treatment for hypoactive sexual desire disorder (HSDD)
Validation of the Decreased Sexual Desire Screener (DSDS) in HSDD in Japan

Fibromyalgia

Literature review of PROs and endpoints of pain in fibromyalgia
Competitive assessment and burden of illness in fibromyalgia
Assessment of the feasibility of achieving claims for cognitive functioning in fibromyalgia
Gap analysis and endpoint review in fibromyalgia
Validation of the fatigue Visual Analogue Scale (VAS) and Jenkins Sleep Scale for fibromyalgia
Development of a manuscript on fatigue and sleep triangulation results in fibromyalgia
Development of a manuscript on the use of the Jenkins Sleep Scale on patients with fibromyalgia
Focus groups to determine the best questionnaire to assess fibromyalgia and recommendations for clinical trials
Assessment of PROs in fibromyalgia
Development of a manuscript in fibromyalgia (reporting results from focus groups and Delphi panel phases)
Endpoint review of fatigue and functioning in fibromyalgia
Development of a conceptual framework for the measurement of fatigue in patients with fibromyalgia
Pilot testing interviews on fibromyalgia fatigue
Consultancy relating to the psychometric validation of the daily diary of fatigue symptoms in fibromyalgia (DFS-Fibro)
Manuscript reporting the results from the validation of the DFS-Fibro
PRO assessment in fibromyalgia and diabetic peripheral neuropathy
Development of a dossier on the Daily Diary of Fatigue Symptoms – Fibromyalgia (DFS-Fibro) and regulatory consultancy for fibromyalgia
Consultancy for fibromyalgia fatigue study
Post-hoc Rasch analysis of existing data from the DFS-Fibro
Validation study of the modified version of the Brief Pain Inventory – Short Form (mBPI-SF), MOS-S and 3 single item questions in fibromyalgia and diabetic peripheral neuropathy
Report of sleep problems in fibromyalgia
Burden, economics, epidemiology and treatment patterns in fibromyalgia

Fragile X syndrome

Consultancy support for clinical trials in Fragile X syndrome
Literature review to develop a conceptual model for individuals with Fragile X syndrome (aged 5-12 years old)

Fungal infections

Strategic review of the key clinical and health outcomes evidence available/planned for an antifungal medication in order to perform a message audit for each key economic value message (including identification of evidence gaps)
Global value dossier and value story for a product in fungal infections
Simultaneous development and regulatory documentation of two PRO questionnaires to assess the signs and symptoms of interdigital tinea pedis and rosacea
Cost-effectiveness analysis of an antifungal drug in Sweden
Adaptation of a model on an antifungal medication for the USA and UK
Simultaneous development and regulatory documentation of two PRO questionnaires to assess the signs and symptoms of interdigital tinea pedis and rosacea

Galactosialidosis

Development of a COA strategy in galactosialidosis

Gastric cancer

Global value dossier for treatment in gastric cancer
Development of a cost-calculator for a biosimilar for gastric cancer
Review of a SMC submission for a chemotherapy drug for advanced gastric cancer
Burden of disease deck, payer value dossier deck and frequently asked questions deck in gastric cancer
Payer value deck in 1st line gastric cancer
Response to payer questions in 1st line gastric cancer
Literature and PRO strategy for gastric oesophageal cancer
Literature review and development of a PRO strategy for gastric cancer
Statistical analyses to support HRQoL in gastric cancer, and estimation of EQ-5D utilities for an Asian population in a trial based on existing data and non-Asian trial utility data
Advisory board attendance and presentation for utilities in gastric cancer and illustrative summary analyses
Utilities analyses to support economic modelling in gastric cancer
Updates to a Health Impact Projection (HIP) model in gastric cancer

Gastroesophageal reflux disease and gastric reflux

Literature review of COA endpoints in paediatric gastric reflux
Activities to confirm the cross-cultural validity of a conceptual model in paediatric gastro-oesophageal reflux disease (GERD)
Manuscript on the simultaneous development of the Paediatric GERD Caregiver Impact Questionnaire (in gastroesophageal reflux disease) in American English and American Spanish
Cognitive debriefings in patients with GERD
De-identification of transcripts in GERD
Content validity and pilot testing of the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-DD) in the UK and five European markets

Gastroparesis

Testing of the validity of gastroparesis symptom questions
Sub group analysis of gastroparesis patients interviewed in exploratory phase, Rasch analysis and PCA on a 5 item scale
Phase III statistical analysis plan and regulatory consulting on the gastroparesis symptom assessment (GSA) for submission
Review of a protocol amendment for a phase II gastroparesis study which includes the Care-giver Strain Index (CGSI) as a primary endpoint
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

Gaucher’s disease

Payer research to understand evidence requirements for reimbursement in Gaucher’s disease
HTA recommendations analysis in Gaucher’s disease
Development and validation of a questionnaire in Gaucher’s disease

Glaucoma

Two mini value dossiers in glaucoma
Patient interviews on glaucoma treatment characteristics and outcomes: Unmet patient needs & value drivers
Development of a utility instrument in glaucoma

Glioblastoma

Development of a global value dossier in the treatment of glioblastoma
AMCP dossier in glioblastoma multiforme
Early global value dossier in newly diagnosed glioblastoma
Clinical trial analyses to support health-related quality of life (HRQoL) in glioblastoma
Review of instruments for a glioblastoma trial and recommendation of a strategy
PRO dossier on glioblastomas for the EMA
Literature review on overall survival and progression-free survival in glioblastomas
Poster on the association of HRQoL and NCF with progression-free survival (PFS) and PD in glioblastoma
Indirect comparison of two treatments in 2nd line glioblastoma
Training slide deck for COAs in glioblastoma

Glucose transporter type 1 deficiency syndrome

Qualitative research to explore and support the assessment of the patient experience and impact of functioning of movement disorders in glucose transporter type 1 deficiency syndrome, and literature review in absence seizures

GNE myopathy

Review and support for the development of a FDA dossier in patients with GNE Myopathy
Development of a manuscript describing the GNE Myopathy Functional Activity Scale (GNEM-FAS) validation
Development of a user manual for the GNEM-FAS validation
Analysis of the GNEM-FAS validation
Support for translations of the GNEM-FAS
Post-hoc analyses to aid interpretation of change in GNE Myopathy endpoints including the primary endpoint of the strength composite score

Gout

Patient interviews to inform the development of a PRO strategy to support labelling claims in gout
Manuscript on patient interviews to inform the development of a PRO strategy to support labelling claims in gout