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.

Other women’s health experience

  • Visual aid and flyer for a drug in pelvic organ prolapse
  • Value demonstration and communication of UK burden of nausea and vomiting during pregnancy
  • Report on the humanistic burden and psychometric validation of the breast pain and vaginal bleeding e-diaries, the breast sensations and vaginal bleeding impact questionnaires and the treatment satisfaction questionnaire
  • FDA meeting on a functioning claim for cyclical mastalgia
  • Psychometric analysis of quality of life questionnaires in women’s health
  • Data entry and analysis of SMILE data received from a clinical trial in women’s health
  • Generation of utility measures in women’s health and rescoring of the Women’s Health Questionnaire (WHQ)
  • Patient preference and utility study for an injectable hormone treatment
  • EVAPIL-R communications and strategic advice regarding the modification of existing PRO measures in women’s health
  • Development of a PRO best practices document – interactions with international regulatory and HTA agencies in women’s health

Ovarian cancer

  • Payer value slide kit in ovarian cancer
  • FAQ guide in ovarian cancer
  • Market access tools implementation guide in ovarian cancer
  • Standalone budget impact models in ovarian cancer
  • Evaluation of patient perspectives on oral versus intravenously-administered treatments for ovarian cancer
  • Survey development for treatment preference in ovarian cancer
  • Provision of consulting services to support PRO labelling and publication strategy for a clinical development program in ovarian cancer
  • Cognitive debriefing interviews to assess usability of an ePRO device for use in forthcoming clinical trials in ovarian cancer
  • Literature and PRO review in ovarian cancer and pain consultancy
  • Literature review and consultancy on ovarian cancer
  • Strategic consultation on oncology endpoints and analysis in ovarian cancer
  • Psychometric evaluation and score interpretation of the national comprehensive cancer network-functional assessment of cancer therapy ovarian symptom Index-18 administered with patients who have advanced ovarian cancer

Overactive bladder and urinary incontinence

  • Value dossier for a treatment in stress urinary incontinence
  • HTA review and analysis for urinary incontinence
  • Abstracts, posters and a manuscript on the content validity of a patient bladder diary and the incontinence quality of life questionnaire
  • Further qualitative development of the incontinence quality of life questionnaire
  • Development of a PRO report on quality of life in urinary incontinence
  • Development of a regulatory dossier and claims assistance in idiopathic overactive bladder (OAB) with urinary urge incontinence
  • Recommendations for obtaining EMEA claims on the Incontinence Quality of Life Questionnaire (I-QOL) and the King’s Health Questionnaire (KHQ)
  • Content validation and psychometric validation of the Kings Health Questionnaire in incontinent OAB patients
  • Development of a PRO dossier for the FDA to support the King’s Health Questionnaire on OAB
  • Content validation and psychometric validation of an incontinence questionnaire for patients
  • Content validation of the patient bladder diary for OAB with urinary urge incontinence
  • Health outcomes appendices for phase III neurogenic OAB studies
  • Development and validation of a clinical screening tool for OAB in multiple sclerosis
  • Advisory board for a clinical screening tool for OAB in multiple sclerosis
  • Publications from the tool development and validation projects of OAB in multiple sclerosis
  • Development of health outcomes appendices in idiopathic OAB
  • Preference evaluation to compare treatments for OAB
  • Mode of administration study in an OAB population
  • Economic dossier on an antispasmodic, anticholinergic agent for OAB
  • Review of screening tools in OAB
  • Item pooling for OAB
  • Development of a screener for OAB based on a pragmatic approach and item pooling
  • SAP, analysis, report and manuscript on the OAB-S questionnaire
  • Standalone validation study in treatment-naive OAB patients
  • Development of a tool for ranking the importance of OAB symptoms and the achievement of treatment goals
  • Review of data and promotional claim strategy in OAB
  • Cognitive debriefing of an OAB questionnaire
  • Linguistic validation of a natural remedy for OAB
  • Phase I disease progression study of OAB in Sweden
  • Development of a patient satisfaction questionnaire in OAB
  • Validation of the Overactive Bladder Satisfaction (OAB-S) Questionnaire
  • Support activity on the OAB-S questionnaire
  • Development of a briefing package in relation to the concept of urinary urgency
  • FDA meeting attendance on the development of a briefing package in relation to the concept of urinary urgency
  • Cognitive debriefing of a new PRO assessment for urinary urgency
  • Worldwide advisory board on a treatment for OAB

Pain (other)

  • Manuscript on Delphi panels in transdermal and intravenous patient-controlled analgesia (IV PCA) in pain patients
  • Literature research and value story update in pain
  • Global value dossier and e-v@luate platform development in pain
  • Competitor landscape review and model in pain
  • Review of documents for strategic recommendation on the validation of a questionnaire in opioids treatment for pain
  • Analysis of FDA and EMEA PRO claims in the areas of pain and inflammation
  • Literature review of functional scales in pain
  • Development and administration of a PRO to assess needle pain
  • Workshop for the development of a needle pain PRO questionnaire
  • Seminar on PROs in acute, chronic and acute recurring pain
  • Adaptation of a price elasticity cost-effectiveness model in pain

Acute pain

  • Development of early cost utility and budget impact models for acute pain

Chronic pain

  • Core value dossier update in chronic pain
  • Targeted literature review in chronic pain
  • Manuscript on phase III quality of life data in severe chronic pain
  • Usability testing of ePRO devices ahead of their use in forthcoming clinical trials in chronic pain
  • PRO review in chronic pain

Trauma pain

  • Understanding the payer landscape and funding flows for trauma pain therapy in the emergency setting
  • Literature review and publication on trauma pain therapy in the emergency setting
  • Global value dossier and e-v@luate platform for a product in trauma pain
  • Global value dossier summary poster in trauma pain
  • Manuscript and structured literature review on product value in trauma pain

Pancreatic cancer

  • Global value dossier and e-v@luate platform in a drug used to treat pancreatic cancer
  • PRO review and gap analysis in pain in advanced pancreatic cancer in support of a labelling claim

Parkinson’s disease

  • Global value dossier for a treatment in Parkinson’s disease
  • Cost effectiveness model on Parkinson’s disease in the USA
  • Pricing research for a new Parkinson’s disease treatment
  • Literature review, strategic consultancy, stakeholder interviews and outcomes assessment in Parkinson’s disease
  • Validation of the transfer of a patient diary for Parkinson’s disease from a paper version to an electronic diary
  • Psychometric validation of the IDQ in Parkinson’s disease
  • Consultation on linguistic validation of the IDQ in Parkinson’s disease
  • Naturalistic health outcomes trial in Parkinson’s disease
  • Development of a PRO strategy for a treatment in Parkinson’s disease
  • Development of an endpoint/measurement strategy for Parkinson’s disease
  • Literature review in Parkinson’s disease
  • Concept elicitation and cognitive debriefing interviews in GBA-Parkinson’s disease
  • Longitudinal quality of life and HE study in Parkinson’s disease patients with drug-induced dyskinesia
  • Abstract on a longitudinal quality of life and HE study in Parkinson’s disease patients with drug-induced dyskinesia
  • Conference poster on the results from a qualitative study of the impact of dyskinesia on Parkinson’s disease patients
  • Assessment of the impact of nocturnal syndrome on Parkinson’s disease patients

Peripheral arterial disease

  • Literature review of burden of illness and cardiovascular risk group identification of symptomatic peripheral artery disease
  • Payer research in symptomatic peripheral arterial disease

Pertussis

  • Data review on the burden of pertussis and other infections
  • Burden of disease literature review on pertussis in the UK and Ireland

Phenylketonuria

  • Value dossier update for a treatment in phenylketonuria (PKU)
  • Updating of a cost manuscript for PKU
  • Value strategy, landscape analysis, health economic model and value dossier development for PKU
  • Development of a poster on a Delphi Panel in PKU
  • Payer research, payer/KOL interviews and rapid assessment of an opportunity in PKU
  • Measurement strategy consulting for endpoint hierarchy development in PKU
  • FDA briefing document to support a client’s phase III study measurement strategy in PKU
  • Outcomes interviews in PKU, resource use and impact on patients

Pneumococcal disease

  • Manuscripts on the health economics of a pneumococcal vaccine
  • Manuscript on cost-effectiveness analysis in pneumococcal disease
  • Manuscripts on a vaccine for pneumococcal disease
  • Payer value deck for pneumococcal disease
  • Payer value deck for a pneumococcal disease vaccine
  • Payer communications on pneumococcal disease
  • Payer communications on a vaccine for pneumococcal disease
  • Payer material development for vaccines in pneumococcal disease
  • Responses to payer questions update on a pneumococcal disease vaccine
  • Update to a one-page value proposition on a pneumococcal disease vaccine
  • ev@luate platform for vaccine franchises in pneumococcal disease
  • Payer resources (payer value deck, FAQs and one-pager) for a pneumococcal vaccine
  • Payer value deck in adult pneumococcal disease (pneumococcal conjugate vaccination)

Pneumococcal vaccines

  • Manuscripts on the health economics of a pneumococcal vaccine
  • Manuscripts on a vaccine for pneumococcal disease
  • Payer communications on a vaccine for pneumococcal disease
  • Responses to payer questions update on a pneumococcal disease vaccine
  • Payer value deck update for a pneumococcal disease vaccine
  • Payer material development on a pneumococcal disease vaccine
  • Update to a one-page value proposition on a pneumococcal disease vaccine
  • ev@luate platform for vaccine franchises in pneumococcal disease
  • Payer resources (payer value deck, FAQs and one-pager) for a pneumococcal vaccine
  • Payer value deck in adult pneumococcal disease (pneumococcal conjugate vaccination)

Pneumonia

  • Manuscript on a real-world evidence literature review in Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP)
  • Manuscript and e-v@luate platform in respiratory outcomes for HABP and VABP

Polio

  • Burden of disease literature review on polio in the UK and Ireland

Post-operative ileus

  • Literature review of the management of post-operative ileus in Europe
  • Analysis of the burden of illness of post-operative ileus in 4 European countries
  • Analysis of post-operative ileus in a complicated population using country-specific databases

Pre-menstrual dysphoric disorder and pre-menstrual syndrome

  • Analysis of a menstrual distress questionnaire in pre-menstrual syndrome (PMS) using trial data
  • Consultation on a response to the FDA regarding the validation of a primary endpoint in pre-menstrual dysphoric disorder (PMDD)
  • Support of an endpoint dossier for regulatory submission in PMDD
  • Review and research of articles on PMDD criteria
  • Cross-validation of the Premenstrual Symptoms Screening Tool (PSST) and the Daily Record of Severity of Problems (DRSP) for use in patients with PMDD and PMS
  • Conference poster documenting the symptoms and impact of PMDD during the luteal phase and the appropriateness of the Daily Record of Severity of Symptoms Tool
  • Productivity assessment in PMDD

Presbyopia

  • Development of a PRO instrument in presbyopia
  • Development of an abstract and manuscript to communicate the results of a Social Media Listening project in presbyopia

Prostate cancer

  • Development of a global value dossier and value story slide set on chemotherapy naïve metastatic castration-resistant prostate cancer
  • Systematic literature reviews, abstract and poster development in prostate cancer
  • Steering committee meetings and manuscript on prostate cancer
  • US budget impact model in metastatic castration-resistant prostate cancer (mCRPC) and 10 country adaptations
  • Literature review of patient experience and treatment satisfaction in prostate cancer
  • Literature review to support validity and adequacy of the Functional Assessment of Cancer Therapy – Prostate (FACT-P), Brief Pain Inventory (BPI) and brief fatigue inventory (BFI) in prostate cancer
  • Literature and instrument review in castration-resistant prostate cancer
  • Literature review and consultancy on prostate cancer
  • Evaluation of content validity of the Cancer Therapy Satisfaction Questionnaire in prostate cancer
  • Manuscript on the evaluation of content validity of the Cancer Therapy Satisfaction Questionnaire in prostate cancer
  • Consultancy on the experience of M1 hormone naïve prostate cancer (mHNPC) patients on a specified chemotherapy drug
  • Articles for an endpoint review in BPI and FACT-P
  • Statistical analysis plan and analyses of the BPI using phase II data on the treatment of hormone-refractory prostate cancer
  • Development of an abstract and poster documenting the psychometric validation of the BPI-SF in castration-resistant prostate cancer patients
  • Strategic consulting for a PRO strategy in castration-resistant prostate cancer – scenario development for data interpretation
  • Publication strategy to support an evidence dossier in pain due to hormone-refractory prostate cancer and bone metastases
  • Investigation of PRO results for a phase III clinical trial in castration-resistant prostate cancer
  • Measurement strategy in prostate cancer
  • Post-hoc analysis of a phase III clinical trial in castration-resistant prostate cancer
  • PRO claim recommendations in pain related to bone metastases in hormone refractory prostate cancer