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 viral infections and anti-viral treatments

Cost-effectiveness model for cytomegalovirus (CMV) prophylaxis in kidney transplant recipients

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

Pancreatic exocrine insufficiency

Development of a PRO for inclusion in pancreatic exocrine insufficiency studies

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

Pompe’s disease

Defence of endpoints for Pompe’s disease

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