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.

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

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

Growth hormone deficiency

  • Strategic literature review to select PRO for a paediatric growth hormone deficiency trial
  • Establishing support of content validity for the modified Injection Pen Assessment Questionnaire (IPAQ) in growth hormone deficiency
  • Injection Pen Assessment Questionnaire (IPAQ) field study in growth hormone deficiency

Haemochromatosis (Iron overload)

  • Consulting on a manuscript on a hereditary haemochromatosis and phlebotomy PRO and market research
  • FDA memo for the development and validation of a screening tool to identify patients with haemochromatosis
  • Utility study for treating for iron overload
  • Submission to the All Wales Medicines Strategy Group (AWMSG) for a treatment for chronic iron overload
  • Submission to SMC for a treatment for chronic iron overload
  • Manuscript on the utility of oral versus subcutaneous iron chelation therapy
  • High level consulting: PRO strategy for reimbursement packages in Europe for iron overload
  • Clinician and patient interviews for a PRO in iron overload
  • Abstacts, posters, analyses, report and manuscript on iron overload
  • High level consulting: PRO strategy for reimbursement packages in iron overload for Italy and France, using satisfaction and self-esteem data
  • PRO analyses and validation manuscript in iron overload
  • Development of a PRO augmentation and manuscript in iron overload
  • Analysis and communications of PRO data from a clinical trial in iron-overload patients receiving iron chelation therapy
  • Communication of PRO data from a clinical trial in iron-overload patients receiving iron chelation therapy

Haemophilia

  • Literature review and report on haemophilia B
  • Literature review in haemophilia A
  • Value messages and payer testing for treatment of haemophilia A
  • Budget impact model for haemophilia in Japan
  • Consultancy support for a PRO strategy in haemophilia
  • Critical review of PROs to inform a PRO Strategy for anti–tissue factor pathway inhibitor (Anti-TFPI) in haemophilia A
  • Exit interviews to assess the impact of infusion frequency in haemophilia A
  • Consulting work in haemophilia
  • Systematic review of haemophilia treatments
  • IRB submission for haemophilia patient interviews
  • Development of a compliance questionnaire in haemophilia
  • Development of a novel tool to evaluate patient preference for a reconstitution device for haemophilia A in a real-world setting
  • Testing of a web-based tool to evaluate patient preference for a reconstitution device for haemophilia A in a real-world setting
  • Development of a content-valid life interference questionnaire for haemophilia
  • Patient expert advice meetings – mode of action (MOA) equivalency for hemophilia bleed and infusion diary
  • Patient expert advice meetings – usability for hemophilia bleed and infusion diary