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.

Herpes zoster (shingles)

  • Payer communications on herpes zoster
  • Payer communications on a herpes zoster vaccine
  • A review of HTA guidance in nine countries to determine requirements for indirect costs in herpes zoster
  • Review of cost-effectiveness studies in post-herpetic neuralgia (PHN)
  • PRO literature review, instrumentation, gap analysis and recommendations in herpes zoster and post-herpetic neuralgia (PHN)
  • Development of a conference abstract and poster on herpes zoster and post-herpetic neuralgia
  • Development of two manuscripts on a herpes zoster study
  • Literature review investigating the burden of disease of herpes zoster and post-herpetic neuralgia in Europe
  • Systematic literature review on the caregiver burden in herpes zoster (shingles) and post-herpetic neuralgia
  • Searches to update a critical review of evidence documenting the humanistic, economic and societal burden of herpes zoster in Europe
  • Research study on the impact on quality of life in herpes zoster
  • Systematic literature review report on herpes zoster
  • Validation of the Numerical Rating Scale (NRS) in post-herpetic neuralgia
  • Payer material development for vaccines in shingles
  • e-v@luate platform on vaccines for shingles

Severe aplastic anaemia

  • Caregiver interviews to support content validity of an ObsRO in a paediatric population with severe aplastic anemia
  • Palatability and acceptability of a treatment in paediatric populations with severe aplastic anemia
  • Development of a scoring algorithm for an acceptability and palatability questionnaire in severe aplastic anemia

Von Willebrand disease

  • Development and validation of a PRO measure in von Willebrand disease and haematology
  • Pre-validation work to inform a clinical trial in von Willebrand disease
  • In-trial validation of a PRO instrument in von Willebrand disease

Sickle cell disease

  • Development of a PRO questionnaire in sickle cell disease
  • Exit interviews in sickle cell disease

Short stature

  • Gap analysis of the Quality of Life in Short Stature Youth (QOLISSY) questionnaire in small for gestational age patients

Immune thrombocytopenic purpura

  • Analysis and reporting on immune thrombocytopenic purpura
  • Caregiver interviews to support content validity of an ObsRO in a paediatric population with chronic immune thrombocytopenic purpura
  • Palatability and acceptability of a treatment in paediatric populations with chronic immune thrombocytopenic purpura
  • Development of a scoring algorithm for an acceptability and palatability questionnaire in chronic immune thrombocytopenic purpura
  • Literature review and qualitative research to support the content validation of the immune thrombocytopenia quality of life index

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

Thalassemia

  • Conference poster on the utility of oral versus subcutaneous iron chelation therapy for beta thalassaemia
  • In-trial analyses of two treatments in thalassemia (TASTE-PRO)
  • Manuscript support in thalassemia (TASTE-PRO)
  • Modification of a satisfaction questionnaire for patients with thalassaemia receiving phlebotomy or oral therapy
  • Clinical Trial analysis of PRO questionnaires in thalassaemia patients

Short bowel syndrome

  • Initial market access evidence assessment for a new orphan drug for short bowel syndrome
  • UK patient disease journey in short bowel syndrome

Rotavirus

  • Payer material development for vaccines in rotavirus gastroenteritis (RVGE)
  • e-v@luate platform on a vaccine for rotavirus

Eosinophilic gastroenteritis

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

Irritable bowel syndrome

  • Literature review of PROs and endpoints of pain in irritable bowel syndrome (IBS)
  • Literature review and manuscript on IBS
  • Patient interviews and qualitative work on IBS
  • Analysis of focus group data in IBS
  • Productivity workshop in IBS
  • Focus groups in IBS
  • Consulting for PROs for a treatment used in IBS
  • Prospective outcomes study in IBS
  • PRO strategy in generalized anxiety disorder with functional digestive disorders / IBS
  • Mixed methods analysis of cognitive debriefing data in irritable bowel syndrome with constipation or chronic constipation (IBS-C/CC)
  • PRO dossier in IBS-C
  • Independent analysis, evidence saturation and report on 30 interviews in IBS-C
  • Development of a PRO strategy for paediatric IBS-C
  • Literature review in IBS-C
  • Manuscript based on the findings of the exit interview study of patients taking a treatment for IBS-C within a long term safety study
  • Exploratory analysis of PRO data to support the interpretation of change on IBS-C abdominal symptom endpoints
  • Development of PRO instruments assessing symptoms and health related quality of life for paediatric patients with IBS-C
  • Testing and cognitive debriefing interviews for a diary in paediatric symptoms of IBS-C/CC
  • Network meta-analysis of treatments for IBC-C/CC
  • Conference poster and debriefing of paediatric IBS-C
  • Cognitive debriefing of a PRO measure of IBS-C symptoms
  • Long term safety study and participation interviews in IBS-C
  • Consultation on a project on IBS-C
  • FDA meeting on IBS-C
  • Interviews with clinicians to understand diagnoses of paediatric IBS-C
  • Development and validation of a primary endpoint to support an indication in irritable bowel syndrome with diarrhoea (IBS-D)
  • Psychometric validation of a newly developed PRO for IBS-D
  • Analysis of qualitative data on IBS-D from focus groups
  • Psychometric validation for a newly developed PRO in IBS-D
  • Development of a PRO measurement dossier on IBS-D for submission to the FDA
  • Development of a PRO instrument assessing symptoms in paediatric patients with IBS-D
  • Assistance with preparations for an FDA type C meeting on IBS-D
  • Development and validation of a primary endpoint for an FDA submission in IBS-D
  • Selection of PROs for IBS-D, regulatory strategy and support
  • Phase II data analysis: Interim and final psychometric testing in IBS-D
  • Manuscript on IBS-C and IBS-D

Constipation

  • Market access consultancy in the treatment of chronic idiopathic constipation
  • Cognitive debriefing interviews for a paediatric constipation symptom diary
  • Development of a PRO strategy for paediatric chronic constipation
  • Development of PRO instruments assessing symptoms and health-related quality of life for paediatric patients with chronic constipation
  • Development of a primary endpoint to assess quality of life in paediatric constipation
  • Providing support in the design and set up of a paediatric functional constipation dose ranging study, updating the eCOA and incorporation of the eCOA into the trial, and support in performing psychometric validation using the trial data
  • Face and content validation of an e-diary to assess opioid-induced constipation and other gastrointestinal side effects in chronic non-cancer pain
  • Planning and execution of an advisory board to obtain feedback on the PRO strategy and plans for the phase III program for a treatment for opioid-induced constipation
  • Patient interviews to assess content validity of an instrument for use in opioid-induced constipation
  • Cognitive debriefing of 7-day recall period for the Patient Assessment of Constipation, Quality of Life Questionnaire (PAC-QOL) and Patient Assessment of Constipation Symptoms (PAC-SYM) in opioid-induced constipation
  • PAC-SYM and analysis of a skin patch containing an opioid pain medication
  • Review of patient diaries and PRO questionnaires for evaluating constipation in opioid-treated non-cancer pain
  • In-depth interviews, instrument development and cognitive debriefing related to measurement of opioid-induced constipation
  • Validation of a patient e-diary to assess opioid-induced constipation
  • Consolidation of results on the development of a bowel function diary for opioid-induced constipation
  • Endpoint model, conceptual framework, cognitive debriefing interview, saturation point and report on opioid-induced constipation
  • Cognitive debriefing of a PRO measure of paediatric chronic constipation
  • Long term safety study and participation interviews in chronic constipation
  • Consultation on a project on chronic constipation
  • Manuscript based on a literature review in paediatric constipation
  • Literature review on chronic constipation
  • FDA meeting on chronic constipation
  • Interviews with clinicians to understand diagnoses of paediatric chronic constipation

Crohn’s disease

  • Early global value dossiers for a new monoclonal antibody in Crohn’s disease
  • Literature review and recommendations for Crohn’s disease
  • Payer objection/question responses in Crohn’s disease
  • White paper on PROs in Crohn’s disease
  • FDA briefing document on Crohn’s disease
  • Advisory board on a treatment for Crohn’s disease
  • Development and implementation of a plan to deliver economic and outcomes evidence to support commercialisation of a treatment for Crohn’s disease in key markets
  • US database analysis to support a pharmacoeconomic model in Crohn’s disease in the US
  • PRO review in Crohn’s disease
  • PRO gap analysis and initial PRO dossier development in Crohn’s disease
  • Support in development and analyses of a patient support programme in Crohn’s disease

Ulcerative colitis

  • Payer objection/question responses in ulcerative colitis
  • Manuscript reporting the literature review and qualitative research project with ulcerative colitis subjects
  • Workshop and FAQ development in immunology in ulcerative colitis
  • Development of a payer value deck in immunology in ulcerative colitis
  • PRO gap analysis and initial PRO dossier development in ulcerative colitis
  • Support in development and analyses of a patient support programme in ulcerative colitis

Subcutaneous fat

  • Development of PRO instruments for anterior and posterior peri-axillary fat
  • Content validity testing of the lower facial shape questionnaire and regulatory support
  • End of phase II regulatory support for PRO endpoints in submental fat
  • Analytic and strategic support in cosmetic/submental fat
  • Non-parametric statistics PRO endpoints on cosmetic surgery on the chin
  • Revisions of a photonumeric scale in centralized abdominal bulging
  • Content validity of PROs in submental subcutaneous fat

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