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.

Chronic obstructive pulmonary disease (COPD)

  • Value proposition for a new metered dose inhaler to treat chronic obstructive pulmonary disease (COPD)
  • External expert assessment of a drug for COPD
  • Development of a global market access value pack to support regional/local access teams and HTA submissions in COPD
  • Value pack (objection handler and budget impact/cost minimisation model) in COPD
  • Conference abstract and poster development on COPD
  • Manuscript on the budget impact of a new treatment in COPD
  • Updates to critical handling error manuscript in chronic obstructive pulmonary disease (COPD)
  • Structured literature review and qualitative interviews with payers/HCPs on a device for COPD
  • Value messaging and HE training support in COPD
  • Protocol development support for a conjoint patient preference study in COPD
  • PRO strategy support for an inhaler treatment for COPD
  • Literature review, FDA briefing document and FDA meeting related to the development of an ePRO for well controlled days in COPD
  • Targeted literature review of PRO measures in frequently exacerbating COPD patients
  • Literature review and research around treatment experiences of patients with COPD
  • Exit interviews to explore patient disease burden, treatment satisfaction and clinical trial participation in muscle wasting associated with COPD
  • Development and delivery of a manuscript on the results from a trial in COPD
  • Translation and validation of the chronic obstructive pulmonary disease population screener (COPD-PS) in Japan
  • Poster presentation on the validation of the COPD-PS in Japan
  • Manuscript on the validation of the COPD-PS in Japan
  • Poster on the development of the Cough and Sputum Assessment Questionnaire (CASA-Q) in COPD
  • Development of a user manual for the cough and sputum assessment questionnaire
  • Validation of the CASA-Q trial
  • Cross-team review of a CASA-Q PRO dossier in COPD for submission to the FDA
  • FDA support for the CASA-Q in COPD
  • Support at investigator meetings for the CASA-Q
  • Psychometric validation of the Shortness of Breath Questionnaire in COPD
  • Validation of a questionnaire for assessing control status of patients with COPD
  • Development of a dyspnoea scale in COPD
  • Development and validation of a satisfaction questionnaire in COPD
  • Development of a symptom diary in COPD
  • Validation of a patient diary to assess symptoms of COPD
  • Development of a poster and validation of a questionnaire in COPD
  • Development and validation of an ePRO in COPD
  • Mixed treatment comparison between competing interventions for COPD
  • Association between exacerbations, a respiratory questionnaire and the use of rescue medication in COPD
  • Network meta-analysis of two treatments for COPD
  • Network meta-analysis of one drug versus fixed dose combinations in COPD
  • Network meta-analysis of competing interventions in the management of COPD
  • Conference presentation on a network meta-analysis of a treatment for COPD
  • Development of a preference-based instrument specific to COPD
  • Validation of a patient diary for evaluating acute exacerbation of chronic obstructive pulmonary disease (AECOPD)

Other ophthalmology experience

  • Slides to outline the intravitreal injection process in the UK
  • Value messages and objection handlers for anti-vascular endothelial growth factor therapy (anti-VEGF) treatment in diabetic retinopathy and retinopathy of prematurity
  • Exploratory analysis of phase II clinical trial data for acute optic neuritis
  • Manuscript on health-related quality of life trial results of a new lens
  • Analysis of focus group results in post-Lasik corneal sensitivity
  • Development and validation of a pterygium instrument
  • Development of a briefing document on a visual function questionnaire
  • PRO review of the subjective eyelid swelling scale for patients with eyelid swelling upon awakening in the morning
  • Analysis and reporting on completed interviews about eyelid swelling
  • Literature review of retinopathy of prematurity
  • Review of PRO measures in diabetic macular edema
  • Development of a PRO measure to assess impacts of full eye rejuvenation

Other oncology experience

  • Scenario model and value messages for oncology in Australia, France, Austria, Switzerland, Belgium, Germany, Italy, Slovenia and the Netherlands
  • Scenario model and policy messages in oncology (Health Impact Projection) for Korea, Norway and Germany
  • Development of a slide deck on the Health Impact Projection in oncology for presentation at a conference
  • Development of a Health Impact Projection model in oncology for Korea, Turkey, and other countries in Europe and Globally
  • Development of an evidence evaluation framework in cancer
  • Creative values demonstration in oncology
  • Budget impact model and clinical data update for the Health Impact Projection in oncology
  • Health Impact Projection oncology model adaptation for Japan
  • Training on a UK budget impact model for a chemotherapy drug
  • External communications for a multi-indication VBP model in oncology
  • Value based pricing model manuscript in oncology
  • Adaptation of a value-based pricing (VBP) multi-indication global model in oncology to Belgium and the US
  • Cost utility model and pilot version of the Safety Profile Model for oncology
  • Economic model for an erythropoietin treatment in cancer
  • Extension and creation of economic evidence on an erythropoietin treatment in cancer
  • Burden of disease deck on biomarkers in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) advanced (stage IV) cancerous tumours
  • Payer value deck on biomarkers in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) advanced (stage IV) cancerous tumours
  • Response to payer questions on biomarkers in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) advanced (stage IV) cancerous tumours
  • Response to payer questions update on biomarker response in various cancer indications
  • Support for the commercialisation of treatment for an immune-response modifier in oncology
  • Competitor intelligence tracking in oncology
  • Implementation guide in all indications of oncology
  • Frequently asked questions deck in oncology biomarkers and companion diagnostics
  • EU market access training in oncology
  • Steering committee meeting in oncology
  • Face-to-face meeting with external experts for review and validation of scenario policy model in oncology
  • Country-level advisory board for a health impact model in oncology
  • Country specific advisory board for the Health Impact Projection model for the Netherlands
  • One-day workshop on Health Impact Projection in oncology
  • Slovenia-focused advisory board on the Health Impact Projection tool in oncology
  • Literature and reimbursement review of IV versus SC oncology therapies, and development of a conference poster
  • Systematic literature review on oncology drugs that have made the switch from IV to SC formulation
  • Literature review and consultancy on oncology
  • PRO consulting for regulatory affairs and investigator training slides in malignant ascites
  • PRO endpoint consulting in oncology
  • Clinical investigator PROs for chemotherapy trials
  • Comprehensive PRO strategy in oncology
  • Support in the development of a PRO strategy for four compounds in 6-8 oncology indications
  • PRO booklet review and edits adaptation on cancer
  • Selection and implementation of PROs such as health-related quality of life and symptoms assessment in the clinical development of new compounds in the field of oncology
  • Consultancy in administration of PROs in a clinical oncology trial
  • Statistical review of PRO aspects of an oncology protocol
  • EMEA training on PROs in haematology and oncology
  • Identification of PRO measures suitable for implementation in phase III oncology and immunotherapy trials
  • Strategic consulting on PRO endpoints for FDA approvable claims
  • Development of a PRO best practices document – interactions with international regulatory and HTA agencies in oncology
  • PRO oncology workshop
  • Development of a PRO dossier for the Cancer Therapy Satisfaction Questionnaire (CTSQ) for the FDA
  • Carcinoid protocol review and outcomes strategy in oncology
  • Develop a reimbursement submission checklist in oncology
  • Consulting and participation in an EU/USA payer advisory board meeting on oncology
  • HEOR strategic consulting in oncology
  • Consulting and exploratory analysis of clinical trials of an intravenous drug treatment for cancer
  • Training session on health economics and outcomes research (HEOR) in oncology
  • Advisory board meeting on oncology
  • Strategic consultancy on recommendations of efficacy analyses in oncology using PRO data
  • Symposium oral presentation on clinical trial analyses to support health-related quality of life in oncology
  • Support MRI and qualitative analyses to document conceptual equivalence of an additional linguistic version of the Ascites Impact Measure (AIM) questionnaire
  • Development and validation of a measure of symptomatic malignant ascites leading to paracentesis for relief of abdominal discomfort
  • Assessment of the disease & TX-related symptoms and concepts for 7 oncology indications, and comparison to available measurement tools
  • Development and validation of a generic chemotherapy instrument
  • Psychometric validation of the Cancer Chemotherapy Satisfaction Questionnaire
  • Oncology post trial questionnaire, strategic review and content validation
  • Strategic review and content validation of a measure to evaluate the experience of participating in a clinical trial in oncology
  • Manuscript on the validation of the Cancer Therapy Satisfaction Questionnaire (CTSQ)
  • Literature review on autonomy for an intravenous drug treatment for cancer
  • Preferences and experiences of cancer patients and their families
  • Cognitive debriefing interviews for the development of a generic chemotherapy instrument
  • Team presentation on how to develop a PRO measure and interact with the FDA in oncology
  • Comparison of a generic EQ-5D-3L utility measure to new cancer-specific utility measure (QLU-C10D) and the EQ-5D-3L/5L cross-walks
  • Decision-making survey on granulocyte colony stimulating factor (G-CSF) in oncology
  • Review and confirmation of content validity of an existing cancer quality of life tool
  • Validation and implementation of a cancer tool to asses doctor and patient communication
  • Cognitive debriefing interviews to confirm the face and content validity of the modified cancer care plan communication tools
  • Development of an evidence evaluation framework in cancer
  • Statistical analyses of endpoints in oncology
  • Translations project in oncology

Kidney cancer / Renal cell carcinoma

  • Landscape analysis for ablation in kidney cancer
  • Burden of disease deck in renal cell carcinoma
  • Market access payer value tool in renal cell carcinoma
  • Analyses of endpoints in oncology: Statistical analyses in renal cell carcinoma
  • Analyses of endpoints in oncology: Country-specific EQ-5D utilities in renal cell carcinoma
  • Clinical trial analyses to support health-related quality of life in renal cell carcinoma: Ad hoc analyses and Q&A document
  • Quick review of PRO measures for a phase II trial in renal cell carcinoma
  • General consultancy agreement to review two PRO measures in renal cell carcinoma to support labelling claims with the FDA and EMA
  • Utilities analyses to support economic modelling in renal cell carcinoma
  • Value tool for decision making in renal cell carcinoma
  • e-v@luate platforms in renal cell carcinoma
  • Summary presentation of a workstream in renal disease
  • Caregiver burden in renal cell carcinoma in the EU
  • Scientific communication of a systematic literature review on caregiver burden in renal cell carcinoma

Prostate cancer

  • Development of a global value dossier and value story slide set on chemotherapy naïve metastatic castration-resistant prostate cancer
  • Systematic literature review in prostate cancer
  • 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

Lymphomas

B-cell lymphoma

  • Payer evidence dossiers in B-Cell lymphoma
  • Development of a budget impact model for primary mediastinal B-cell lymphoma (PMBCL)
  • Literature review and preparation of a PRO strategy in large B-cell lymphoma
  • Burden of diffuse large B-cell lymphoma on patients and caregivers
  • e-v@luate platform in diffuse large B-cell lymphoma

Hodgkin’s lymphoma

  • Payer evidence dossiers in non-Hodgkin’s lymphoma
  • Early payer engagement deck in classical Hodgkin’s lymphoma
  • Analyses of endpoints in oncology: Statistical analyses in Hodgkin’s lymphoma
  • Clinical trial analyses to support health-related quality of life in Hodgkin’s lymphoma

Non-Hodgkin’s lymphoma

  • Update of a payer evidence dossier in non-Hodgkin’s lymphoma
  • Literature review and conceptual mapping in non-Hodgkin’s lymphoma
  • Strategic PRO endpoint support, gap analysis and patient interviews in a biological therapy treatment for non-Hodgkin’s lymphoma
  • Validation of a patient satisfaction questionnaire in non-Hodgkin’s lymphoma
  • Conference poster and slide deck on non-Hodgkin’s lymphoma
  • Manuscript on a budget impact model for a cross-indication biosimilar in diffuse large B-Cell lymphoma, follicular lymphoma, follicular non-Hodgkin’s lymphoma

Lymphomas (other)

  • Core value dossier and value proposition in cutaneous T-cell lymphoma
  • Development of a budget impact tool for a treatment for chronic lymphatic lymphoma for Spain
  • Support programme for reimbursement submissions in cutaneous T-cell lymphoma
  • Strategic consulting for a lymphoma trial
  • Clinical trial analysis of health-related quality of life data in patients with previously untreated follicular lymphoma
  • Manuscript on a budget impact model for a cross-indication biosimilar in diffuse large B-Cell lymphoma, follicular lymphoma, and follicular non-Hodgkin’s lymphoma

Leukaemia

  • Exploring physicians’ perceptions of adherence levels, reasons for non-adherence, and opinions of how to improve adherence in leukaemia patients receiving treatment
  • Patient satisfaction in chemotherapy for leukaemia

Acute lymphoblastic leukaemia

  • Support in IRB submissions and scientific dissemination in acute lymphoblastic leukaemia
  • Burden of refractory acute lymphoblastic leukaemia on patients and caregivers

Acute myeloid leukaemia (AML)

  • Global value dossier and e-v@luate platform for a treatment in AML
  • Global value dossier, conference poster and medical writing support in AML
  • Quality of life analysis in the treatment of AML
  • Payer evidence council value communication materials (booklet, slides and Q&A) to inform phase III trial design in AML
  • Cost-effectiveness analysis and budget impact analysis for a prognostic and minimal residual genetic tests for AML
  • Systematic literature review of healthcare resource utilisation in AML
  • Literature review of resource utilisation in AML
  • Strategic consulting on AML
  • Health-related quality of life in elderly patients with AML: Position paper on an AML treatment for inclusion in a value dossier
  • Qualitative research to understand the value of extended overall survival to AML patients

Chronic lymphocytic leukaemia (CLL)

  • Utility study in advanced CLL
  • Abstract and manuscript on utility study results in CLL
  • Payer evidence dossiers for treatments of CLL
  • Mixed treatment comparison and training meeting on a global value dossier for a treatment for CLL
  • Health state preference study mapping the change over the course of the CLL disease process
  • Conference poster on the health state preference study mapping the change over the course of the CLL disease process
  • Global value dossier for a treatment in CLL
  • Statistical analysis plans and provision of PRO support to the client for their trials of a biological therapy cancer treatment for CLL
  • General consultancy agreement to review PRO measures in CLL
  • Analysis of PRO data from the CLL registry
  • Manuscript on a budget impact model for a cross-indication biosimilar in CLL

Chronic myeloid leukaemia (CML)

  • Value dossier support in CML linking myelosuppression with quality of life impact
  • Value dossier support in CML linking response to utilities and additional analysis
  • Critical review of PRO instruments in CML
  • Adverse event to PRO linking in CML
  • Manuscript on AE-PRO linking in CML
  • Targeted literature review and manuscript on factors associated with adherence in CML
  • Development of a link between side effects and PROs in CML – a univariate approach

Cervical cancer

  • Budget impact model in cervical cancer
  • Development of a PRO strategy in cervical cancer and HPV
  • Summary report, top-up literature review, meta-analysis, editorial board and manuscripts on HPV infection and cervical cancer

Breast cancer

  • Global value dossier for treatment in breast cancer
  • Data collection of costs associated with breast cancer care
  • Manuscript on the German model for a hormonal drug used in the treatment of breast cancer
  • Development of two budget impact models in breast cancer with population data by city
  • Two budget impact models for Italy for an injectable chemotherapy drug for breast cancer
  • Budget impact model in breast cancer for France
  • Development of a cost-calculator for a biosimilar for breast cancer
  • Payer value deck in breast cancer
  • Payer value deck update for a breast cancer biosimilar
  • Burden of disease deck in breast cancer
  • Response to payer questions in breast cancer
  • Response to payer questions update for a breast cancer biosimilar
  • Burden of disease deck and frequently asked questions deck in breast cancer biosimilars
  • One-pager communication in a breast cancer biosimilar
  • Productivity and QoL study in breast cancer
  • Literature review and consultancy on breast cancer
  • e-v@luate platforms in breast cancer

HER2 positive breast cancer

  • Literature review of productivity data in HER2 positive breast cancer
  • Budget impact model for a biosimilar in HER2 breast cancer

Advanced breast cancer

  • Development of a perceived tolerability questionnaire in first line treatment of advanced breast cancer
  • Strategy for an injectable chemotherapy drug for advanced breast cancer and submission to NICE/SMC
  • Budget impact model and analysis for an injectable chemotherapy drug for advanced breast cancer in 5 EU countries
  • Economic evaluation of a therapy for postmenopausal women with advanced breast cancer (with the perspective of 3rd party national and local payers in the UK)
  • Development and population of an economic model in advanced breast cancer
  • Conference poster on a cost utility analysis of two treatments for advanced breast cancer
  • Conference poster on the economic evaluation of a therapy for postmenopausal women with advanced breast cancer
  • Phase IV non-interventional prospective observational study comparing patient reported outcomes in advanced breast cancer
  • PRO label review manuscript development in advanced/metastatic breast cancer

Metastatic breast cancer

  • Value dossier and e-v@luate platform in metastatic breast cancer
  • Scientific communication of cost-effectiveness analysis in metastatic breast cancer
  • PRO knowledge base instruments and methods library for metastatic breast cancer

Triple negative breast cancer

  • Global value dossier and upload to e-v@luate platform in triple negative breast cancer
  • Data analyses on a multi-indication budget impact model and cost utility model in triple negative breast cancer
  • Payer value tool in triple negative breast cancer (TNBC)
  • Standalone budget impact models in triple negative breast cancer

Other cardiovascular diseases

  • Value proposition development for three Integrated Delivery Networks (IDNs) within the cardiovascular system
  • Review of the HTA submissions & economic literature in lipid modification
  • Development of a clinical tool to identify patients at risk of stent thrombosis
  • Update of a budget impact model for an anorectic antiobesity drug for cardiometabolic risk
  • Service impact model on cardiovascular complications in obesity
  • Development of a value proposition for amyloid cardiomyopathy
  • Mixed treatment comparison to estimate the efficacy of a drug relative to other treatments for patients with elevated triglycerides
  • General consulting on a new stent device
  • Validation of the Flushing Severity Questionnaire (FSQ) in patients with niacin induced flushing (NIF)
  • Manuscript on a heart model and statins
  • Strategic review of a treatment for atherothrombosis to prevent blood clots following a heart attack or stroke
  • Analysis of the risk of cardiovascular events with an antiplatelet medicine and proton pump inhibitors (PPI) in Japan
  • Protocol review, case report form and analysis plan for a treatment to prevent complications of vascular surgery

Other infectious disease experience

  • HEOR team capabilities audit and training plan in infectious diseases
  • Literature review and development of a suite of dossiers in anti-infectives (anti-bacterial resistance)
  • Development of an e-v@luate EVIDENCE platform for a vaccines portfolio
  • Literature review of antibiotic resistance
  • Cost effectiveness analysis model for Portugal on a treatment for bacterial diabetic foot infections
  • Suite of dossiers for an anti-infective in gram-negative infections
  • Pharmacoeconomic and PRO design and analysis for an immunoglobulin product
  • Analysis in an EU study in primary immunodeficiency
  • Pricing reimbursement overview for the UK for a novel anti-viral treatment
  • Cost effectiveness model on a treatment for bacterial infections
  • Cost-effectiveness analysis of a treatment of intra-abdominal infections in the USA
  • Development of a manuscript and consultation on economic evaluations alongside a clinical trial in intra-abdominal infections
  • Protocol, CRF and distress diary development in infectious diseases
  • COA consultancy support and validation of a nasal congestion scale

Human immunodeficiency virus (HIV) / Acquired immune deficiency syndrome (AIDS)

  • Business planning toolkit in HIV
  • Development of a payer value story in HIV
  • Payer value story briefing document in HIV
  • Review of an economic model for HIV and submission to the SMC
  • Budget impact model in HIV
  • Targeted literature review of adherence in HIV
  • Targeted literature review in HIV and inflammation
  • Targeted literature synthesis of viral blips and viremia in patients with HIV
  • Literature review on inflammation in patients with HIV
  • Consulting in a multinational case-control study: Impact of side effects on the quality of life (QoL) of HIV patients
  • Advisory board consultation regarding product status and development in HIV
  • General consultancy on PRO endpoints in HIV/AIDS trials
  • Recommendations for the inclusion of PROs into HIV trials
  • Development of an expert report and FDA meeting on tolerability in HIV
  • Consulting on the development of a PRO strategy for international HIV trials with interviews in the US and Puerto Rico
  • Consulting on study documents and development of SAP for psychometric validation of a PRO instrument of tolerability in patients with HIV
  • Preparation and development of a manuscript on HIV Patient Symptom Profile (HIV PSP)
  • Preliminary psychometric validation of the HIV PSP questionnaire using the UK SWITCH study data
  • Analysis of HIV PSP data from the SWITCH study to compare treatment arms
  • Confirming concept definitions of the HIV Treatment Tolerability Index for translation purposes
  • An evidence synthesis on the efficacy and safety of two drugs and protease inhibitors in treatment‑naïve HIV patients
  • Manuscript network meta-analysis of an antiretroviral drug for the treatment of HIV
  • Budget impact tool for an antiretroviral drug for treatment-naive HIV
  • Literature review of the epidemiology and burden of illness in HIV-related neuropathy
  • Top-up literature review, revised manuscript and presentations on HIV and AIDS
  • Development and psychometric validation of a PRO instrument of tolerability in patients with HIV
  • Two abstracts, two posters and a manuscript on the development and psychometric validation of a PRO instrument of tolerability in patients with HIV
  • Selection of PRO measures for HIV trials

Diabetes

  • Critical review of economic models, development of initial economic model structure in excel, development of budget impact model and publication in type 2 diabetes
  • Budget impact models for a biosimilar in type 1 and type 2 diabetes mellitus
  • Budget impact model for payer discussions in diabetes
  • Communication on a formulary pack for medication in type 2 diabetes
  • NICE submission and SMC submission for an injectable drug for treatment of type 2 diabetes
  • SMC submission dossier for a treatment for type 2 diabetes
  • Payer strategy analysis of literature search results in type 2 diabetes
  • Payer value proposition and communication for a new remote patient monitoring platform in diabetes
  • Payer value deck in diabetes
  • Payer value slide deck for a biosimilar in diabetes
  • Payer communications in diabetes using data from the short form health survey (SF36)
  • Costing of pre-diabetes care in the US
  • Development of abstracts, posters and a manuscript on the critical review of economic models in diabetes
  • Global value dossier, AMCP and accompanying slide sets for an insulin biosimilar
  • Global value dossier updates, AMCP dossier updates and literature review in diabetes
  • Targeted literature review of the burden of type 2 diabetes mellitus
  • Systematic literature anaylsis on GLP1 receptor agonists in type 2 diabetes
  • e-v@luate EVIDENCE platform development for diabetes
  • Manuscript on the barriers to intensification of insulin treatment in patients with type 2 diabetes in the Netherlands
  • Review of an Iranian manuscript on the cost of diabetes
  • Burden of disease in diabetes: Developing journal and conference publications based on market research data
  • Scientific communication for a time trade off (TTO) study in diabetes
  • Scientific communication of a Swedish cost-effectiveness analysis in diabetes
  • Manuscript on patient preference and willingness to pay in diabetes for South Africa
  • Scientific communications for a diabetes patient preference study in the UK
  • Scientific communications on a bolus insulin dosing study
  • Data collection for the use of long-acting insulin in the UK
  • Analysis and summary of outputs of client research with key opinion leaders to support reimbursement submissions and internal communications in diabetes mellitus (type 1 and 2)
  • Key opinion leader testimonials report and German data update in diabetes mellitus (type 1 and 2)
  • Key opinion leader testimonials poster in diabetes
  • Willingness to pay utility study in diabetes
  • Scientific communications for a willingness to pay study in diabetes
  • Frequently asked questions in diabetes
  • Posters regarding long acting insulin usage
  • Attendance at and strategic input into a diabetes workshop
  • Content validation of the paediatric quality of life questionnaire (PEDSQL) for type 1 diabetes mellitus
  • PRO selection, implementation, analysis and reporting on a low carbohydrate (CHO) trial in type 2 diabetes
  • Exploratory analyses and slide deck for a CHO trial in type 2 diabetes
  • PRO selection, implementation, analysis and reporting in type 2 diabetes mellitus
  • Gap analysis, endpoint model and FDA recommendations in type 2 diabetes
  • Recruitment and cognitive debriefing of three patients with type 2 diabetes
  • Indirect comparison of a treatment in type 2 diabetes
  • Systematic review of two treatments for type 2 diabetes
  • Validation of a hypoglycaemia questionnaire in type 2 diabetes
  • Development and validation of a PRO measure of hypoglycaemia, weight gain, tolerability and compliance in type 2 diabetes
  • Blind data review of a clinical trial in type 2 diabetes
  • Clinical trial analysis of a dose ranging study in type 2 diabetes mellitus
  • Analysis of PROs in two clinical trials in type 2 diabetes mellitus
  • Analysis of changes in HbA1C and health-related quality of life (HRQoL) in type 2 diabetes
  • Analysis of hypos versus no hypos in type 2 diabetes mellitus
  • Post-hoc analysis of clinical trial data: Linking clinical outcomes to PRO outcomes in type 2 diabetes mellitus
  • Biostats training and SAS program development for EQ-5D training in type 2 diabetes mellitus
  • Development of a dossier on the novel hypo instruments in type 2 diabetes mellitus
  • HEOR strategy support and study development in type 2 diabetes mellitus
  • Patient interviews in type 2 diabetes for development of a new PRO measure
  • Strategic literature review in type 2 diabetes
  • Literature review and development in type 2 diabetes
  • Consultation on a market research study on patient perceptions of pre-filled insulin pens
  • PRO analysis of a diabetes pre-post meal study
  • Gap analysis to identify the most responsive diabetes PRO measure for clinical trials
  • Validation of a revised symptom checklist in diabetes
  • Validation of the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) for diabetes in Japan
  • Cognitive debriefing on the perceptions about medications diabetes questionnaire (PAM-D)
  • Development of a manuscript on patient perceptions of prefilled insulin delivery devices
  • Database evaluation of costs and outcomes of diabetes treatment
  • Linguistic validation of the Diabetes Symptom Checklist-Revised (DSC-R) into UK English
  • Burden/cost of illness analysis of patient preference for once-weekly treatment in diabetes
  • Literature review examining the benefits of memory function on treatment adherence in diabetes
  • Development of a PRO strategy in diabetes
  • Evaluation of the potential for a satisfaction claim in an insulin product
  • Psychometric validation of a paediatric satisfaction instrument in diabetes
  • Analysis of a prevention clinical trial in diabetes
  • Strategic consulting and training in diabetes to support a client
  • Analysis of a patient qualitative assessment of a diabetic treatment after Ramadan
  • Analysis of clinical trial PRO data to assess patient-perceived and individualised benefit/risk of diabetic treatment

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

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

Acute pain

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

Chronic pain

  • Core value dossier update 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

Migraine

  • Literature review of cardiovascular disease in migraine patients
  • Systematic literature review in migraine
  • Development of a PRO measure in chronic adolescent migraine
  • Statistical analysis plan for in-trial psychometric validation of the assessment of chronic migraine symptoms and impacts measures
  • Gap analysis and assessment of PROs in migraine
  • Development of a PRO measure in postdrome migraine
  • Development of an FDA briefing document and regulatory support in chronic migraine
  • Qualitative interviews in chronic migraine headaches
  • Gap analysis of PRO measures in paediatric migraine
  • Generation of evidence for the content validity of instruments assessing motor weakness in hemiplegic migraine
  • Review of concussion PROs relating to migraine

Depression

  • Development of an online therapy tool for depression along with a landscape analysis, structured and grey literature review, local language literature review, gap analysis, local language payer interviews and clinician interviews
  • Literature review and advisor feedback on the burden of illness, clinical and economic outcomes in US patients receiving adjunctive treatment for major depressive disorder
  • Literature review of the burden of depression in haemodialysis patients (in chronic kidney disease)
  • Literature review and sourcing of UK unit costs in depression
  • KOL interviews and Delphi method to estimate the direct health care costs of treating patients with treatment-resistant depression
  • Manuscript and content validity of a PRO measure in major depressive disorder
  • Validation of the Children’s Depressions Rating Scale – Revised (CDRS-R) in Japan
  • Translation of the CDRS-R manual
  • PRO dossier on major depressive disorder for EMA submission
  • Development of an EMA technical document for PROs in depression
  • Instrument review and development of an EMA technical document to support patient-reported health-related quality of life labelling claims in depression
  • Communications on PRO clinical trial data and a literature review on depression
  • Development of a manuscript and presentation based on clinical trial PRO data in depression, primarily focused on interpretation of treatment
  • Validation and treatment effect analysis of the Sleep Impact Scale (SIS) in major depressive disorder
  • Review of PRO and CRO measures in severe depression
  • Selection of a PRO for depression in multiple sclerosis (MS)
  • Linguistic validation of a quality of life questionnaire on depression into UK English
  • Manuscript on validation and efficacy results in depression

Dementia

  • Linguistic validation of the Neuropsychiatric Inventory (NPI) in dementia
  • Structured literature review in lewy body dementia
  • Network meta-analysis in dementia with lewy bodies
  • Manuscript on dementia with lewy bodies
  • Clinical trial synopsis consulting for a phase III clinical program in dementia

Allergic rhinitis

  • Structured review of medication adherence in allergic rhinitis compared with other treatments for chronic conditions
  • Communications and manuscript on a survey of the impact of allergic rhinitis on sleep
  • 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

Dermatitis

  • Mini value dossier in atopic dermatitis
  • Payer value materials in atopic dermatitis
  • Analysis of the impact of chronic hand dermatitis on work productivity among healthcare workers in the UK
  • COA consulting support for a numeric rating scale in pruritus
  • Preparation of qualitative data in atopic dermatitis for FDA submission
  • Translation and linguistic validation of the numerical rating scale (NRS) in pruritus and cognitive debriefing of an ePRO diary
  • Development of a symptom-based PRO instrument in atopic dermatitis
  • Development of a PRO in adult atopic dermatitis
  • Psychometric evaluation of PROs in adult atopic dermatitis
  • COA development and content validity in atopic dermatitis
  • Development of a manuscript to communicate the patient experience of atopic dermatitis
  • Regulatory support in adolescent atopic dermatitis
  • Development and cognitive debriefing of a symptom diary for use in adults and adolescents with atopic dermatitis
  • Two abstracts to communicate the development of the atopic dermatitis adult and adolescent conceptual models
  • Usability testing of electronic handheld numeric rating scale (NRS) items in atopic dermatitis
  • Linguistic validation and translation of the PRE-FACE
  • Relationship between clinical outcome assessment (COAs) and objective measures in atopic dermatitis and sleep