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.

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

Myocardial infarction

  • Literature review of the unmet need in patients with a history of myocardial infarction and high risk of developing atherothrombotic events
  • Literature review of coronary artery bypass grafting (CABG) treatment in acute myocardial infarction (AMI)
  • Validation of clinician and patient questionnaires for myocardial infarction imaging
  • Development and validation of patient and clinician tools for myocardial infarction imaging
  • Analysis and reporting of myocardial infarction imaging validation study data
  • Clinician and patient satisfaction in an observational study in myocardial infarction SPECT imaging

Hyponatremia

  • Qualitative study to support the content validity of the trail making test and MOS-Cognition in patients with hyponatremia
  • Psychometric validation study of the TMT-B and MOS-Cognition tests in patients with hyponatremia
  • Regulatory support for cognition endpoints of a treatment for hyponatremia
  • FDA advisory committee meeting support for HRQoL endpoints in hyponatraemia

Dyslipidaemia

  • Development of a manuscript from an existing report detailing an analysis already performed using an existing economic model in dyslipidemia

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)

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

Smoking

  • Psychometric validation of a cohort study on adherence to lifestyle changes in weight loss and smoking cessation
  • Development and validation of a questionnaire to assess well-being changes in people who would like to lose weight and quit smoking
  • Focus groups assessing patient experience with smoking
  • Development of a readiness to quit smoking tool for use in clinical practice
  • Gap analysis of the Questionnaire of Smoking Urges (QSU) to support labelling claims in smoking cessation
  • Literature review of PROs in smoking cessation
  • Regulatory consulting for smoking cessation
  • Briefing document in smoking cessation
  • Confirmatory psychometric analyses of the Leicester Cough Questionnaire (LCQ) in smokers
  • Linguistic validation of the Brief Questionnaire of Smoking Urges (BQSU), Minnesota Nicotine Withdrawal Scale (MNWS) and Smoking Effects Inventory (SEI) into UK English

Opioid addiction

  • Development of a screening tool for opioid dependence
  • Endpoint review and qualitative research in opioid addiction
  • Interviews and Rasch analysis in opioid addiction
  • Psychometric validation of the clinical opiate withdrawal scale (COWS), subjective opiate withdrawal scale (SOWS) and craving visual analog scale (VAS) in opioid withdrawal symptoms

Haemophilia

  • Literature review and report on haemophilia B
  • Literature review in haemophilia A
  • Value messages and payer testing for treatment of haemophilia A
  • Budget impact model for haemophilia in Japan
  • Consultancy support for a PRO strategy in haemophilia
  • Critical review of PROs to inform a PRO Strategy for anti–tissue factor pathway inhibitor (Anti-TFPI) in haemophilia A
  • Exit interviews to assess the impact of infusion frequency in haemophilia A
  • Consulting work in haemophilia
  • Systematic review of haemophilia treatments
  • IRB submission for haemophilia patient interviews
  • Development of a compliance questionnaire in haemophilia
  • Development of a novel tool to evaluate patient preference for a reconstitution device for haemophilia A in a real-world setting
  • Testing of a web-based tool to evaluate patient preference for a reconstitution device for haemophilia A in a real-world setting
  • Development of a content-valid life interference questionnaire for haemophilia
  • Patient expert advice meetings – mode of action (MOA) equivalency for hemophilia bleed and infusion diary
  • Patient expert advice meetings – usability for hemophilia bleed and infusion diary

Duchenne muscular dystrophy

  • Gap analysis of clinical outcome assessments and natural history of duchenne muscular dystrophy
  • Qualitative interviews with patients, caregivers and clinicians to define a clinician global impression of change item for duchenne muscular dystrophy

Down’s syndrome

  • Development of a COA strategy for Down’s syndrome in adults and children
  • Clinical meaningfulness of scores on the Vineland Adaptive Behaviour Scale (VABS-II), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Clinician Global Impression (CGI) in Down’s syndrome
  • Strategic literature review to identify COA instruments to assess the concept of independence in Down’s syndrome
  • Qualitative interviews and development of a COA strategy for Down’s syndrome in adults and children
  • Subgroup analysis by chronological age of individuals with Down’s syndrome