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

Adenomyosis

  • Development of disease-specific modules for adenomyosis

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

Allergic rhinitis

  • Structured review of medication adherence in allergic rhinitis compared with other treatments for chronic conditions
  • 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