Therapeutic area

Interstitial cystitis

  • Literature review on interstitial cystitis
  • Development of a PRO for interstitial cystitis
  • Identification of cut-points to allow a newly developed interstitial cystitis symptom PRO to be used to screen patients entering a clinical trial and to assess the psychometric properties of the interstitial cystitis
  • Development of a manuscript on the Painful Bladder/Interstitial Cystitis Symptom Score (PBIC-SS) questionnaire
  • Revision of a manuscript on the PBIC-SS questionnaire and submission to a peer-reviewed journal

Interstitial lung disease

  • Consulting to help inform a PRO strategy for pulmonary hypertension in interstitial lung disease (PH-ILD)
  • Brief literature review to inform endpoint strategy recommendations for interstitial lung disease in systemic sclerosis (SSc-ILD)

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

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
  • Sensitivity analysis and budget impact model on renal cell carcinoma
  • Analyses of endpoints in oncology: Statistical analyses in renal cell carcinoma
  • Updates to a Health Impact Projection (HIP) model in locally advanced or metastatic renal cell carcinoma
  • 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
  • Budget impact model 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

Kidney (renal) disease

  • Core value dossier for a treatment used in stages III, IV and V renal disease
  • Core value dossier in the treatment of secondary hyperparathyroidism associated with chronic kidney disease including end stage renal disease
  • Core value dossier in chronic kidney disease and end stage renal disease
  • Literature review of the burden of depression in hemodialysis patients (in chronic kidney disease)
  • Pilot utility elicitation study in end stage renal disease
  • Logistical costs of changing treatment in chronic kidney disease
  • Capturing costs when switching from one ESA to another for chronic kidney disease in UK hospital trusts
  • Payer research to understand potential pricing and reimbursement in polycystic kidney disease
  • Disease area review, burden of illness and unmet needs in heart failure (and associated renal dysfunction)
  • Meta-analysis of a treatment for chronic kidney disease: trials and PRO endpoints
  • Manuscripts and conference attendance for a treatment in chronic kidney disease
  • FDA meeting support in defence of PRO claims for a treatment for chronic kidney disease
  • Manuscript and advisory board on physical functioning in chronic kidney disease
  • Development of a manuscript and production of two posters on the symptoms of chronic kidney disease when treated with a specific drug
  • Review of a dossier in chronic kidney disease
  • Qualitative interviews, conceptual model and strategic consulting on autosomal dominant polycystic kidney disease (ADPKD)
  • Measures for use in patients with autosomal dominant polycystic kidney and liver disease: development and validation of a symptom measure and validation of a health survey
  • Regulatory consulting on claims with the FDA for a treatment for end stage renal disease (ESRD)
  • Relevance and context of information for a treatment for hyperphosphatemia in patients with chronic kidney disease
  • Preparation of a manuscript on the relevance of pharmacoeconomics studies in renal disease
  • Literature research and assessment of the appetite and activities of daily living in patients with end-stage renal disease

Kidney transplant

  • Kidney transplant pricing research
  • Pricing research on kidney transplant in emerging markets
  • Cost-effectiveness model for cytomegalovirus (CMV) prophylaxis in kidney transplant recipients
  • Healthcare resource use and statistical analysis consulting on a clinical trial for kidney transplantation

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

Liver cancer

  • Development of a HEOR strategy for treatment of hepatocellular cancer
  • Clinical trial analyses to support health-related quality of life in advanced hepatocellular carcinoma
  • Updates to a Health Impact Projection (HIP) model in hepatocellular carcinoma
  • Landscape analysis for ablation in liver cancer

Long-chain fatty acid oxidation disorders

  • Qualitative research to explore and support the assessment of the patient experience and impact on functioning of long-chain fatty acid oxidation disorders
  • Qualitative interviews on long-chain fatty acid oxidation disorders

Lower urinary tract symptoms

  • Cognitive debriefing interviews on the symptom assessment goal achievement questionnaire on lower urinary tract symptoms in the UK, Germany and Spain
  • Data analysis and communication activities on Self-Assessment Goal Achievement (SAGA) in lower urinary tract symptoms

Lung cancer

  • Preparation of 3 existing manuscripts on lung cancer for submission
  • Literature search and analysis of phase 2 vs phase 3 lung cancer studies
  • Literature and reimbursement review of intravenous versus subcutaneous therapies in lung cancer
  • Development of a pan-lung oncology treatment model
  • Landscape analysis for ablation in lung cancer
  • Patient interviews in lung cancer
  • Analyses of endpoints in oncology: Statistical analyses in lung cancer
  • Analyses of endpoints in oncology: Country-specific EQ-5D utilities in lung cancer
  • Analytical evidence for improvement in symptoms and quality of life in lung cancer patients on a specified treatment
  • Analytical evidence for improvement in symptoms and quality of life in pre and post-randomisation lung cancer patients (by age groups)
  • Strategic consulting, research and measurement in solid tumours
  • Strategic communications planning in lung cancer
  • Consulting for an FDA submission in lung cancer
  • Summary presentation of a workstream in lung cancer
  • Updates to a Health Impact Projection (HIP) model in extensive 1st line SCLC, locally advanced or metastatic 2nd line NSCLC, and metastatic 1st line NSCLC

Non-small cell lung cancer (NSCLC)

  • Global value dossier and e-v@luate platform in NSCLC
  • Global value dossier and e-v@luate platform in non-squamous NSCLC
  • Global value dossier and e-v@luate platform in advanced squamous NSCLC
  • Global value dossier for a treatment in metastatic NSCLC
  • Payer value deck and response to payer questions update in 1st line NSCLC
  • Updated payer value dossier deck and FAQs deck for 1st line NSCLC
  • Updated burden of disease decks, payer value dossier decks and FAQs decks for 1st line and 2nd line NSCLC
  • Societal costs, health-related quality of life systematic literature review and publications plan for NSCLC in Europe
  • Literature review of overall survival and bone metastases in NSCLC
  • Literature review to inform global market access materials in NSCLC
  • Structured literature review in advanced 1st line NSCLC
  • Systematic review and mixed treatment comparison in advanced NSCLC
  • Development of technical documentation and manuscript on NSCLC
  • Two manuscripts on the indirect comparison of the efficacy of two different therapies for NSCLC
  • Development of a manuscript on the cost-effectiveness of a treatment in NSCLC in Italy
  • Manuscript on the efficacy of three different drugs for the treatment of NSCLC
  • Model review of a drug used in the treatment of NSCLC
  • Multi-indication budget impact model in NSCLC
  • Adaptation of a multi-indication value-based pricing model in NSCLC to China
  • Value-based model in NSCLC
  • Update to a Belgian value-based pricing model in NSCLC
  • Standardisation of economic models in NSCLC
  • Global model update and country adaptations for a multi-indication value-based pricing (VBP) model on NSCLC
  • Burden of disease decks in advanced 1st line and 2nd line NSCLC
  • Burden of disease deck update in 1st line NSCLC
  • Integrated research plan in advanced melanoma and NSCLC
  • Value slide deck for treatment in NSCLC
  • Guidance documents for affiliates in treatment for NSCLC
  • Situational analysis report of epidermal growth factor receptor (EGFR) predictive testing in NSCLC
  • Communication toolkit for a lung cancer supplement
  • Companion diagnostics biomarker FAQs compilation deck in NSCLC
  • FAQs update in advanced 1st line NSCLC
  • FAQs deck update in 2nd line NSCLC
  • Payer slide decks and objection handler in NSCLC
  • Payer tools implementation guide in NSCLC
  • Payer value proposition deck update in 2nd line NSCLC
  • Payer value deck update in advanced 1st line NSCLC
  • Payer value deck and response to payer questions update in 1st line NSCLC
  • HTA submission support in epidermal growth factor receptor positive (EGFR+) and non-small cell lung cancer (NSCLC)
  • Value communication for a matching-adjusted indirect comparison (MAIC) in NSCLC
  • Abstract and manuscript on MAIC in NSCLC
  • Deep-dive trial design in NSCLC
  • Numerous abstracts and conference posters on NSCLC, advanced NSCLC and related treatments
  • Several abstracts and conference posters relating to the cost and cost effectiveness of a first-line treatment option for patients with NSCLC
  • Abstract and poster on progression-free survival and overall survival in patients with NSCLC
  • Literature review of outcomes and costs during treatment for advanced NSCLC
  • Literature review and consultancy on NSCLC
  • Manuscript on stage IIIb and IV NSCLC
  • Development of a measurement dossier in advanced NSCLC for the EMA
  • Meta-analysis and manuscript on stage IIIb and IV NSCLC
  • Development of posters for a MAIC in advanced NSCLC
  • Epidemiology evidence, patient pathway modelling and literature review in advanced NSCLC
  • Statistical analyses of clinical trial data (safety study) in NSCLC
  • Statistical analyses of clinical trial data (observational study) in NSCLC
  • Clinical trial analyses to support health-related quality of life in first-line NSCLC
  • Qualitative study on the needs and preferences of patients with advanced NSCLC for maintenance therapy
  • Development of an analysis plan in NSCLC for the USA and Europe
  • Analysis of PRO data in NSCLC
  • Qualitative interviews to understand the impact of NSCLC on quality of life and on caregivers and family members
  • EQ-5D review for an EMA measurement dossier in advanced NSCLC
  • Exploratory qualitative interviews in NSCLC patients to assess progression-free survival
  • Comparative effectiveness of two treatments for the treatment of NSCLC
  • Feasibility network meta-analysis comparison of two treatments for NSCLC
  • Exploratory analysis of the Visual Symptom Assessment Questionnaire (VSAQ) in patients who have undergone treatment for NSCLC
  • Utilities analyses to support economic modelling in NSCLC
  • Clinical trial analyses to support health-related quality of life in NSCLC
  • Impact of whole brain radiation therapy in patients with NSCLC with brain metastases

Small cell lung cancer (SCLC)

  • Global value dossier and upload to e-v@luate platform in SCLC
  • AMCP dossier in SCLC
  • Systematic literature reviews for the societal and health-related quality of life burden of SCLC
  • Systematic literature review and manuscript on real-world effectiveness and tolerability of treatments in SCLC
  • Literature review on real-world effectiveness and tolerability of treatment in SCLC
  • Utility study in SCLC
  • Development of a budget impact model in SCLC
  • Budget impact model in 1st line SCLC
  • Development of a disease conceptual model and endpoint recommendation for SCLC
  • Phase IV clinical trial analysis of two drugs used in the treatment of SCLC
  • Analysis of symptoms for a drug used to treat SCLC
  • Full text reports on the longitudinal analyses of a drug used to treat SCLC for EU submission
  • Literature and PRO strategy for SCLC
  • Clinical trial analyses to support health-related quality of life in SCLC
  • Literature review and consultancy on SCLC

Lupus and systemic lupus erythematosus

  • Manuscript on the understanding of payers and pricing in lupus nephritis
  • PRO consulting in lupus for labelling claims
  • Assessing utility for flares in systemic lupus erythematosus in the UK, France, Spain, Australia and Canada, including training and managing local interviewing agencies and providing support to local teams
  • Key opinion leader contracting and additional interviews for assessing utility in various severities of flares in systemic lupus erythematosus
  • Study on the treatment of systemic lupus erythematosus in Japan
  • Update of a literature search in systemic lupus erythematosus and lupus nephritis
  • Strategic literature review and gap analysis in systemic lupus erythematosus and lupus nephritis
  • Communication of a literature review on systemic lupus erythematosus and lupus nephritis
  • Indirect treatment comparison, network meta-analysis and feasibility assessment of therapies for lupus nephritis
  • Literature review and network meta-analysis feasibility assessment in lupus
  • Manuscript on the health-related quality of life benefits of a treatment for systemic lupus erythematosus
  • A study of the value of simple disease activity tools to rheumatologists who treat systemic lupus erythematosus
  • Target product profile development in systemic lupus erythematosus
  • Analysis of a PRO and resource utilisation in systemic lupus erythematosus
  • Development of posters on the analysis of a PRO and resource utilisation in systemic lupus erythematosus
  • Critical review of PRO instruments in systemic lupus erythematosus and fatigue and pain in rheumatic disease

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

Macular degeneration

  • Rapid payer research to inform investment decisions in diabetic macular edema
  • Cost-effectiveness model to inform investment decisions in diabetic macular edema
  • Mixed treatment comparison for treatment of patients with wet age-related macular degeneration
  • Burden of blindness study on inherited retinal degenerations
  • Survey protocol for a burden of blindness study
  • Development and validation of a screener and QoL module in macular degeneration
  • Burden of illness in wet age-related macular degeneration in Japan
  • Literature review of visual function literature to support the National Eye Institute Visual Function Questionnaire (NEI-VFQ) in age-related macular degeneration
  • Cross-sectional burden of illness study for age-related macular degeneration
  • FDA claim strategy and endpoint review of a visual function questionnaire in age-related macular degeneration and diabetic macular edema
  • Content validation of a visual function questionnaire in diabetic macular edema

Masseter muscle

  • Development and validation of a PRO for masseter muscle hypertrophy
  • In-trial validation of a PRO for masseter muscle prominence in Canada and Taiwan
  • Development and psychometric evaluation of severity measures in masseter prominence
  • Conceptual equivalency and psychometric evaluation of PRO and ClinRo measures of masseter muscle prominence
  • Interim psychometric evaluation of the lower facial shape questionnaire in masseter muscle hypertrophy

Measles, mumps and rubella (MMR)

  • One-pager value communication tool for the measles, mumps and rubella (MMR) vaccine
  • Payer value deck for an MMR vaccine
  • e-v@luate platform on vaccines for MMR

Meibomian gland dysfunction

  • Gap analysis and development in meibomian gland dysfunction
  • Publication support for PRO gap analysis and PRO measures in meibomian gland dysfunction

Melanoma

  • Adaptation of a multi-indication value-based pricing model in melanoma to China
  • Literature review in metastatic melanoma treatment patterns
  • Scientific communication of a systematic literature review on caregiver burden in advanced metastatic melanoma
  • Global value dossier for a treatment in melanoma
  • Development of global market access materials (disease burden slide deck, payer value story and FAQs) in metastatic melanoma to support local access teams
  • Payer slide decks and objection handler update in metastatic melanoma
  • Implementation guide in metastatic melanoma
  • Burden of disease deck update in ipi refractory and ipi naïve advanced melanoma
  • Payer value proposition deck update in ipi refractory advanced melanoma
  • Payer value proposition deck update in ipi naïve advanced melanoma
  • Updated implementation guide in melanoma
  • Frequently asked questions deck in ipi refractory and ipi naïve advanced melanoma
  • Updated burden of disease deck, payer value dossier decks and obstacle handler in a treatment for refractory & naïve melanoma
  • Development of a budget impact model for adjuvant melanoma
  • KOL interviews and primary research into treatment patterns in adjuvant melanoma
  • Payer value deck and response to payer questions in adjuvant melanoma
  • Payer value deck and response to payer questions update in advanced melanoma
  • Burden of disease deck in adjuvant melanoma
  • Burden of disease and payer value deck in adjuvant and advanced melanoma
  • Standardization of economic models in melanoma
  • Value-based model in melanoma
  • Multi-indication budget impact model in melanoma
  • Global model update and country adaptations for a multi-indication value-based pricing (VBP) model on melanoma
  • Adaptation of a value-based pricing multi-indication global model in oncology to Greece
  • Strategic communications planning in melanoma
  • Update to a Belgian value-based pricing model in melanoma
  • Updates to a Health Impact Projection (HIP) model in adjuvant melanoma and unresectable or metastatic melanoma
  • Preparation of a genomics methods paper in melanoma
  • Summary presentation of a workstream in melanoma
  • Caregiver burden in advanced melanoma
  • Caregiver burden in melanoma in the EU
  • Evidence synthesis on the comparative effectiveness of systemic therapies for unresectable stage IIIc and stage IV melanoma
  • Pilot patient interviews in melanoma
  • Exploratory analyses of endpoints in oncology: Statistical analyses in melanoma
  • Analyses of endpoints in oncology: Statistical analyses in first-line melanoma
  • Clinical trial analyses to support the relationship between adverse events and health-related quality of life, health status and work productivity in melanoma
  • Clinical trial analyses to support health-related quality of life in melanoma: AMNOG analyses for combination arm therapy
  • Network meta-analysis on the efficacy of first line treatment for unresectable stage IIIC/IV melanoma
  • AMNOG analyses to support health-related quality of life in melanoma

Menopause and hormone replacement therapy

  • Health economics on the menopause
  • Cost utility analysis of hormone replacement therapy (HRT)
  • Observational study of HRT
  • Cognitive debriefing of a women’s health screening tool
  • Consultancy on FDA documents on the menopause
  • Psychometric validation of the SAM/WSM using PNS validation study data
  • Literature review of HRT outcomes in the menopause
  • Development of a conceptual model for vasomotor symptoms in post-menopausal women
  • Trial of two drugs used to treat menopausal symptoms
  • Pilot testing of a paper hot flash diary and questionnaire on the menopause
  • Development of a PRO instrument for measuring mood swings and sleep problems resulting from vasomotor symptoms during the menopause
  • Development of a briefing document for measuring the impact of menopausal hot flushes
  • Development of a PRO for breast pain/pressure and vaginal bleeding/spotting for female patients on HRT
  • Manuscript reporting results of qualitative work to support development of a breast pain daily diary (BP-DD) and vaginal bleeding/spotting daily diary (VBS-DD)