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.

Acne

  • PRO gap analysis and competitor review in acne vulgaris
  • PRO development in acne vulgaris
  • Concept elicitation interviews in acne vulgaris to reach saturation
  • Observational psychometric validation study in acne vulgaris
  • Single item validation and user’s manual in acne vulgaris
  • Mixed method evaluation of an acne vulgaris measure – racial equivalence in non-Caucasion subjects using existing data
  • Medical writing for development and validation of a PRO in acne vulgaris
  • Clinical outcome assessments in acne scars
  • Literature research and content validation in acne scars
  • Analysis, reporting and patient interviews PRO in acne vulgaris
  • PRO instrument review in acne
  • Content validity testing of and regulatory support for use of the PRE-FACE in acne vulgaris
  • Linguistic validation and translation of the PRE-FACE

Acromegaly

  • Payer value proposition, payer value dossier and cost effectiveness model in acromegaly
  • Landscape analysis of acromegaly patient registries
  • Adequacy of the Acromegaly Quality of Life Questionnaire (AcroQoL) as an endpoint in acromegaly: endpoint review & strategic recommendations
  • Analysis of PRO data to support clinical trial dissemination activities in acromegaly
  • Consultancy to review acromegaly protocol
  • Exploratory analyses in acromegaly

Actinic keratosis

  • Literature review and stakeholder interviews on payer decision drivers in actinic keratosis
  • Statistical analysis and data interpretation from a multinational observational study in actinic keratosis
  • Manuscripts on a treatment for actinic keratosis
  • Patient diary study and analyses in actinic keratosis
  • Reporting on a patient diary study on adherence to topical treatment in actinic keratosis
  • Update of a dossier and development of a value story slide set to support affiliate teams in the value of an actinic keratosis product
  • Update to a core value dossier and value messages on actinic keratosis
  • Communication of PRO analysis from a phase III trial in actinic keratosis
  • Communication tool and materials on treatment in actinic keratosis
  • Publication summaries on treatment for actinic keratosis
  • Reimbursement dossier for a treatment in actinic keratosis
  • Use of PROs and ClinROs to build the best evidence and optimise market access for actinic keratosis

Alcohol dependence

  • Analysis and report generation on the medical environment for treatment of alcohol dependence
  • Supporting the development of a strategic ‘road map’ to support a publication on the alcohol dependent population
  • Definition of the alcohol dependent population in Europe
  • Literature review to understand the diagnosis, management and referral procedures for alcohol dependency in Japan
  • High level consultancy for a PRO endpoint strategy in alcohol dependence and obsessive compulsive disorder
  • Literature research and analysis on the economic and PRO burden of alcohol dependence

Adenomyosis

  • Development of disease-specific modules for adenomyosis

Other allergic conditions

  • Structured literature review for allergy immunotherapy, including medication adherence compared to other treatments
  • Systematic literature review in allergy immunotherapy products
  • Survey of the impact of allergy on sleep (including literature review and HCP interviews)
  • Portfolio value proposition and literature review on allergy immunotherapy
  • Abstracts and posters for allergy immunotherapy compliance in allergic rhinitis
  • Cost effectiveness analysis of allergy immunotherapy products
  • Internal value communication deck on real world studies in allergic reactions
  • Analysis of phase II symptom data in a study of lactose intolerance
  • Development of a COA strategy to measure treatment side effects for peanut allergy treatments

Allergic rhinitis

  • Structured review of medication adherence in allergic rhinitis compared with other treatments for chronic conditions
  • Communications and manuscript on a survey of the impact of allergic rhinitis on sleep
  • Review of PROs and development of a patient-reported screening tool in allergic rhinitis
  • Preference questionnaire on allergic rhinitis spray devices
  • Comparative preference trial with an experience questionnaire in allergic rhinitis
  • Focus groups assessing patient experience with nasal spray in allergic rhinitis, analysis of results and development of a report on concept elicitation and cognitive debriefing
  • Literature research and communications on the burden of nasal blockage in allergic rhinitis
  • Validation of the preference module of the Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q), with revisions to an FDA briefing document on the development and validation of the EARNS-Q experience and preference modules
  • Manuscript on the development of the EARNS-Q
  • Regulatory support for the EARNS-Q

Alopecia

  • Gap analysis of PROs for the use of a drug to grow darker and longer hair on the scalp
  • Conference poster on a gap analysis in alopecia
  • Development and validation of a photographic assessment and symptom measure in alopecia
  • Development of a symptom and impact PRO in alopecia
  • Development of a treatment satisfaction module for alopecia
  • Brief statistical analysis synthesis and interpretation (photo guide) in alopecia
  • Patient interviews for the development of alopecia-related PRO measures
  • Observational psychometric validation study in alopecia
  • Dossier on PRO measures in alopecia
  • PRO dossier for Subject Self-Assessment of Alopecia (SSAA)
  • Observational psychometric testing study in alopecia
  • Single item analysis in alopecia
  • Development of PRO and ClinRO instruments for alopecia totalis and alopecia universalis
  • Review and provide input into the development of a data analysis plan, validation study, drafts and final report of a randomized controlled trial on alopecia medicine
  • Conceptual equivalence testing of alopecia ePROs
  • Cognitive debriefing of the revised Subject Self-Assessment (SSA) and Hair Growth Questionnaire (HGQ) with patients with androgenic alopecia
  • Psychometric analyses and regulatory support in the development of PRO and ClinRO instruments for alopecia areata patchy, universalis and totalis

Alzheimer’s disease

  • Advisory panel on Alzheimer’s disease
  • Critical analysis and report to support the widespread use of a combination therapy in Alzheimer’s disease
  • Analysis and report generation of widespread use of combination therapy in Europe for the treatment of Alzheimer’s disease
  • Summary report on EMA marketing organisation for a treatment in Alzheimer’s disease
  • Budget impact model in Alzheimer’s disease
  • Disutility study in Alzheimer’s disease
  • Disutility of caregiver burden associated with Alzheimer’s disease in Japan
  • Health state development for mild cognitive impairment in Alzheimer’s disease
  • Early payer value deck for Alzheimer’s disease
  • Development of additional caregiver burden items for the Resource Utilization in Dementia Questionnaire for Alzheimer’s disease
  • Literature research and analysis on the Alzheimer’s disease landscape in Japan
  • Conceptual framework for the Alzheimer’s Disease Caregiver Preference Questionnaire (ADCPQ)
  • Linguistic validation of the ADCPQ into Chinese
  • Validation of the Alzheimer’s disease caregiver preference questionnaire
  • Evaluation of quality of life in cognitively impaired Alzheimer’s disease patients
  • Review of the Alzheimer’s Disease Activity Scale-cognitive subscale (ADAS-Cog)
  • Development of a COA strategy for mild-moderate symptomatic Alzheimer’s disease
  • Development of a trial-specific caregiver satisfaction and preference questionnaire for a treatment for Alzheimer’s disease
  • PRO instrument development, qualification quantitative component of content validity stage and in-trial psychometric analysis stage in mild cognitive impairment
  • Review of the University of California San Diego Performance-based Skills Assessment (UPSA) in Alzheimer’s disease
  • Cognitive debriefing of the Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL) questionnaire
  • Analysis of an open label extension study in Alzheimer’s disease

Anaemia

  • NICE consultancy for a treatment for chemotherapy-induced anaemia
  • Statistical pharmacoeconomic analysis of patient level data for a treatment for anaemia following chemotherapy
  • Linking a cost utility assessment model with a budget impact model for treatment for anaemia in cancer
  • Phase II cognitive interviews and regulatory support in inflammatory anaemia in cancer
  • Evaluation of the PRO landscape using a systematic literature review on chemo-induced anaemia in oncology
  • Patient consultations on anaemia
  • General consulting agreement for iron treatment in anaemia

Anaesthesiology

  • Economic analysis and trial design in hip replacement
  • Health economic endpoints for a locally-acting treatment to provide pain relief after surgery
  • Powerpoint storyboard to support and demonstrate an economic modelling tool in anaesthesiology
  • Preparation of a data collection questionnaire in anaesthesiology for local markets
  • Pricing and reimbursement guidelines on anaesthesia and analgesia for Europe, Canada and Australia
  • Evaluation of the cost of operating time in Japan in relation to anaesthesiology
  • Stakeholder needs analysis in anaesthesiology
  • Recommendation for the use of a PRO in a phase IIIb trial in anaesthesia and face/content validity testing
  • Feasibility of developing a composite endpoint to assess patients’ quality of recovery after surgery requiring anaesthesia and the use of a reversal agent
  • Advisory board on anaesthesia and analgesia
  • Productivity workshop on anaesthesia and analgesia
  • Consultation on PRO assessments and analysis on anaesthesia and analgesia
  • Strategy for FDA translation validity checklist in anaesthesia and analgesia
  • Development of a conceptual framework and SAP for a treatment for neuromuscular block
  • Feasibility study for the surgeon satisfaction questionnaire with quality of surgery related to neuromuscular block
  • Translation of the Bridion Operating Room Study into Japanese
  • Treatment effect analyses based on a Quality of Recovery questionnaire (QoR-40) and Reversal Agent Satisfaction Questionnaire (RASQ) in neuromuscular block
  • Development of a surgeon satisfaction questionnaire for anaesthetic block
  • Endpoint review and gap analysis in bone healing

Angina

  • Gap analysis of PRO measures to substantiate labelling claims in angina trials of a drug-eluting stent (DES)
  • Cognitive debriefing interviews and item finalization for a PRO for microvascular angina (MVA)

Angioedema

  • Telephone consultation on angioedema
  • Strategic PRO and ObsRO consulting of an angiotensin converting enzyme (ACE) inhibitor induced angioedema clinical trial database
  • Cognitive debriefing interviews in ACE inhibitor induced angioedema
  • Investigator training for the ACE inhibitor induced angioedema investigator rating scale
  • Translation and linguistic validation of clinician assessments in ACEI-Angioedema
  • Communications on clinician assessments in ACEI-Angioedema

Animal health

Canines

  • Qualitative activities to support validity and feasibility of the canine quality of life and treatment satisfaction measure administered via a cell phone application
  • Development of a user manual for canine dermatitis quality of life and treatment satisfaction
  • Psychometric evaluation of a revised canine dermatitis quality of life questionnaire
  • Clinical trial analysis and ad-hoc consultancy for a canine quality of life questionnaire
  • Exploration of canine-owner burden in various conditions and provision of recommendations for measurement
  • Psychometric evaluation and analysis of a revised canine dermatitis quality of life questionnaire

Felines

  • Building of a feline QoL tool for cats with GI lymphoma
  • Development and validation of an instrument to measure quality of life in cats
  • Development of a user manual for a feline quality of life tool

Anxiety

  • Validation of the SIS in anxiety
  • Manuscripts on the development and validation of the Sleep Impact Scale (SIS) in generalised anxiety disorder
  • PRO strategy in generalized anxiety disorder with functional digestive disorders / irritable bowel syndrome (IBS)