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.

Eosinophilic gastroenteritis

  • Evaluation of COA tools in eosinophilic gastroenteritis (EGE) and eosinophilic gastritis (EG) with additional longitudinal data collection

Epilepsy

  • Mapping the health economic evidence landscape for anti-epileptic treatments
  • Systematic literature review and mixed treatment comparison for a treatment in epilepsy
  • Abstract review for the systematic literature review and mixed treatment comparison investigating treatments in epilepsy
  • Value dossier for an anticonvulsant medication for use in epilepsy
  • Evidence synthesis and modelling for an anticonvulsant medication in epilepsy
  • SMC submission for an anticonvulsant treatment for epilepsy
  • Brief literature review in epilepsy and search of FDA and EMA websites
  • Payer meeting and consultancy on an anti-epilepsy drug
  • Consultancy on an Italian model adaptation in epilepsy
  • Development of a US value dossier (meeting AMCP and WellPoint guidelines) and an expanded budget impact model on epilepsy
  • Cost-effectiveness analysis of two different anticonvulsant medications as adjunctive therapy for adults with partial refractory epilepsy in the US
  • Mixed treatment comparison summary for epilepsy

Dravet syndrome

  • Development of a composite trial endpoint for Dravet syndrome
  • Interviews on the development of a composite trial endpoint for Dravet syndrome
  • Manuscript on the development of a composite trial endpoint for Dravet syndrome
  • Publication support to disseminate findings from interviews with caregivers of children with Dravet syndrome, and independent qualitative analysis of findings

Lennox-Gastaut syndrome

  • Cost utility analysis model for Lennox-Gastaut Syndrome
  • Training with the client to discuss the Lennox-Gastaut Syndrome economic model/report and payer submission
  • Eliciting utilities in Lennox-Gastaut Syndrome
  • Assistance with responding to questions from the AWMSG and SMC on Lennox-Gastaut syndrome

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

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