Therapeutic area

Female sexuality and sexual desire

Focus study on the Female Sexual Desire Profile (FSDP) and Female Sexual Encounter Profile (FSEP)
Patient interviews and analysis/report on the FSDP and FSEP
Measurement of the impact of quality of life on female sexuality
Critical review of PROs in female sexual disorder
PRO endpoint review for a treatment for hypoactive sexual desire disorder (HSDD)
Validation of the Decreased Sexual Desire Screener (DSDS) in HSDD in Japan

Fibromyalgia

Literature review of PROs and endpoints of pain in fibromyalgia
Competitive assessment and burden of illness in fibromyalgia
Assessment of the feasibility of achieving claims for cognitive functioning in fibromyalgia
Gap analysis and endpoint review in fibromyalgia
Validation of the fatigue Visual Analogue Scale (VAS) and Jenkins Sleep Scale for fibromyalgia
Development of a manuscript on fatigue and sleep triangulation results in fibromyalgia
Development of a manuscript on the use of the Jenkins Sleep Scale on patients with fibromyalgia
Focus groups to determine the best questionnaire to assess fibromyalgia and recommendations for clinical trials
Assessment of PROs in fibromyalgia
Development of a manuscript in fibromyalgia (reporting results from focus groups and Delphi panel phases)
Endpoint review of fatigue and functioning in fibromyalgia
Development of a conceptual framework for the measurement of fatigue in patients with fibromyalgia
Pilot testing interviews on fibromyalgia fatigue
Consultancy relating to the psychometric validation of the daily diary of fatigue symptoms in fibromyalgia (DFS-Fibro)
Manuscript reporting the results from the validation of the DFS-Fibro
PRO assessment in fibromyalgia and diabetic peripheral neuropathy
Development of a dossier on the Daily Diary of Fatigue Symptoms – Fibromyalgia (DFS-Fibro) and regulatory consultancy for fibromyalgia
Consultancy for fibromyalgia fatigue study
Post-hoc Rasch analysis of existing data from the DFS-Fibro
Validation study of the modified version of the Brief Pain Inventory – Short Form (mBPI-SF), MOS-S and 3 single item questions in fibromyalgia and diabetic peripheral neuropathy
Report of sleep problems in fibromyalgia
Burden, economics, epidemiology and treatment patterns in fibromyalgia

Fragile X syndrome

Consultancy support for clinical trials in Fragile X syndrome
Literature review to develop a conceptual model for individuals with Fragile X syndrome (aged 5-12 years old)

Fungal infections

Strategic review of the key clinical and health outcomes evidence available/planned for an antifungal medication in order to perform a message audit for each key economic value message (including identification of evidence gaps)
Global value dossier and value story for a product in fungal infections
Simultaneous development and regulatory documentation of two PRO questionnaires to assess the signs and symptoms of interdigital tinea pedis and rosacea
Cost-effectiveness analysis of an antifungal drug in Sweden
Adaptation of a model on an antifungal medication for the USA and UK
Simultaneous development and regulatory documentation of two PRO questionnaires to assess the signs and symptoms of interdigital tinea pedis and rosacea

Galactosialidosis

Development of a COA strategy in galactosialidosis

Gastric cancer

Global value dossier for treatment in gastric cancer
Development of a cost-calculator for a biosimilar for gastric cancer
Review of a SMC submission for a chemotherapy drug for advanced gastric cancer
Burden of disease deck, payer value dossier deck and frequently asked questions deck in gastric cancer
Payer value deck in 1st line gastric cancer
Response to payer questions in 1st line gastric cancer
Literature and PRO strategy for gastric oesophageal cancer
Literature review and development of a PRO strategy for gastric cancer
Statistical analyses to support HRQoL in gastric cancer, and estimation of EQ-5D utilities for an Asian population in a trial based on existing data and non-Asian trial utility data
Advisory board attendance and presentation for utilities in gastric cancer and illustrative summary analyses
Utilities analyses to support economic modelling in gastric cancer
Updates to a Health Impact Projection (HIP) model in gastric cancer

Gastroesophageal reflux disease and gastric reflux

Literature review of COA endpoints in paediatric gastric reflux
Activities to confirm the cross-cultural validity of a conceptual model in paediatric gastro-oesophageal reflux disease (GERD)
Manuscript on the simultaneous development of the Paediatric GERD Caregiver Impact Questionnaire (in gastroesophageal reflux disease) in American English and American Spanish
Cognitive debriefings in patients with GERD
De-identification of transcripts in GERD
Content validity and pilot testing of the Infant Gastroesophageal Reflux Questionnaire (I-GERQ-DD) in the UK and five European markets

Gastroparesis

Testing of the validity of gastroparesis symptom questions
Sub group analysis of gastroparesis patients interviewed in exploratory phase, Rasch analysis and PCA on a 5 item scale
Phase III statistical analysis plan and regulatory consulting on the gastroparesis symptom assessment (GSA) for submission
Review of a protocol amendment for a phase II gastroparesis study which includes the Care-giver Strain Index (CGSI) as a primary endpoint
Review of protocol on a phase II study of subjects with severe gastroparesis due to diabetes mellitus
Cognitive debriefing of a symptom measure of gastroparesis in diabetics and standalone validation study

Gaucher’s disease

Payer research to understand evidence requirements for reimbursement in Gaucher’s disease
HTA recommendations analysis in Gaucher’s disease
Development and validation of a questionnaire in Gaucher’s disease

Glaucoma

Two mini value dossiers in glaucoma
Patient interviews on glaucoma treatment characteristics and outcomes: Unmet patient needs & value drivers
Development of a utility instrument in glaucoma

Glioblastoma

Development of a global value dossier in the treatment of glioblastoma
AMCP dossier in glioblastoma multiforme
Early global value dossier in newly diagnosed glioblastoma
Clinical trial analyses to support health-related quality of life (HRQoL) in glioblastoma
Review of instruments for a glioblastoma trial and recommendation of a strategy
PRO dossier on glioblastomas for the EMA
Literature review on overall survival and progression-free survival in glioblastomas
Poster on the association of HRQoL and NCF with progression-free survival (PFS) and PD in glioblastoma
Indirect comparison of two treatments in 2nd line glioblastoma
Training slide deck for COAs in glioblastoma

Glucose transporter type 1 deficiency syndrome

Qualitative research to explore and support the assessment of the patient experience and impact of functioning of movement disorders in glucose transporter type 1 deficiency syndrome, and literature review in absence seizures

GNE myopathy

Review and support for the development of a FDA dossier in patients with GNE Myopathy
Development of a manuscript describing the GNE Myopathy Functional Activity Scale (GNEM-FAS) validation
Development of a user manual for the GNEM-FAS validation
Analysis of the GNEM-FAS validation
Support for translations of the GNEM-FAS
Post-hoc analyses to aid interpretation of change in GNE Myopathy endpoints including the primary endpoint of the strength composite score

Gout

Patient interviews to inform the development of a PRO strategy to support labelling claims in gout
Manuscript on patient interviews to inform the development of a PRO strategy to support labelling claims in gout

Growth hormone deficiency

Strategic literature review to select PRO for a paediatric growth hormone deficiency trial
Establishing support of content validity for the modified Injection Pen Assessment Questionnaire (IPAQ) in growth hormone deficiency
Injection Pen Assessment Questionnaire (IPAQ) field study in growth hormone deficiency

Haemochromatosis (Iron overload)

Consulting on a manuscript on a hereditary haemochromatosis and phlebotomy PRO and market research
FDA memo for the development and validation of a screening tool to identify patients with haemochromatosis
Utility study for treating for iron overload
Submission to the All Wales Medicines Strategy Group (AWMSG) for a treatment for chronic iron overload
Submission to SMC for a treatment for chronic iron overload
Manuscript on the utility of oral versus subcutaneous iron chelation therapy
High level consulting: PRO strategy for reimbursement packages in Europe for iron overload
Clinician and patient interviews for a PRO in iron overload
Abstacts, posters, analyses, report and manuscript on iron overload
High level consulting: PRO strategy for reimbursement packages in iron overload for Italy and France, using satisfaction and self-esteem data
PRO analyses and validation manuscript in iron overload
Development of a PRO augmentation and manuscript in iron overload
Analysis and communications of PRO data from a clinical trial in iron-overload patients receiving iron chelation therapy
Communication of PRO data from a clinical trial in iron-overload patients receiving iron chelation therapy

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

Head and neck cancer

Adaptation of a multi-indication value-based pricing model in head and neck cancer to China
Health economic advisory board on a treatment for head and neck cancer
Payer tools implementation guide in head & neck cancer
Payer value proposition deck in 2nd line head & neck cancer
Payer communications strategy and tools in head and neck cancer
Payer communication tool and summary in SCCHN
Burden of disease deck, payer value dossier deck and frequently asked questions deck in 2nd line head and neck cancer
One-pager on HPV in head and neck cancer
Market access and pricing tools to support a value proposition in squamous cell carcinoma of the head and neck (SCCHN)
Market access payer value tool in head and neck cancer
Economic value story in SCCHN
Standardization of economic models in head and neck cancer
Value-based model in head and neck cancer
Multi-indication budget impact model in head and neck cancer
Cost-effectiveness model in head and neck cancer
Global model update and country adaptations for a multi-indication value-based pricing (VBP) model on head and neck cancer
Dossier for a chemotherapy drug for head and neck cancer
Reimbursement dossiers in subgroups of head and neck cancer
Mini literature review in SCCHN
Literature review and payer communication tools in SCCHN
Development of an evidence compendium for HPV-related head and neck cancers
One-pager on HPV-related head and neck cancer
Update to a Belgian value-based pricing model in head and neck cancer
Updates to a Health Impact Projection (HIP) model in recurrent or metastatic head and neck cancer
Update of market access tools in SCCHN
Updates to a global value dossier from a targeted literature review in HPV-related head and neck cancer
Clinical trial analyses to support health-related quality of life in head and neck cancer
Qualitative interviews to assess equivalence of paper and electronically administered questionnaires in head and neck cancer
SMC submission of a chemotherapy drug in head and neck cancer
Two manuscripts and one mini report for the head and neck cancer models for the UK
US costing for a head and neck cancer model
Health-related quality of life analyses to support a treatment for head and neck cancer: a Q-TWiST analysis
AMNOG and ad hoc analyses to support health-related quality of life in SCCHN

Heart disease

Global value dossier on cardiovascular disease and dyslipidaemia
Literature review of cardiovascular disease in migraine patients
Update of a report on the impact of changing total cholesterol targets in the General Medical Services (GMS) contract for heart disease
NHS and public health impact of revising General Medical Services (GMS) targets for cholesterol in coronary heart disease
Manuscript on the cost-effectiveness and budget impact of a statin treatment for coronary heart disease
Targeted literature review and value messages for cardiovascular disease
Investigator training and analysis of QoL data in heart disease
Analysis of the prevalence of bradycardia and co-morbidities in coronary artery disease
Data management and reporting of an outcomes project on a statin drug for the treatment of heart disease
Analysis of the SF-ESTQ in the JEWEL studies in heart disease
PRO questionnaire development for statin intolerance
Demonstrating the value of a transcatheter heart valve in aortic stenosis
Report on the cost of diagnosing vascular diseases with an MRA as the primary imaging modality
Consultation on an epidemiological quality of life study in cardiovascular disease
Development of a PRO best practices document in cardiovascular diseases – interactions with international regulatory and HTA agencies

Heart failure and transthyretin amyloid cardiomyopathy (ATTR-CM)

Payer value proposition and communication for a new remote patient monitoring platform in congestive heart failure
Objection handlers in transthyretin amyloid cardiomyopathy (ATTR-CM)
Objection handler and value story updates in ATTR-CM
Payer research/interviews and value proposition testing in ATTR-CM
Disease area review, burden of illness and unmet needs in heart failure (and associated renal dysfunction)
Development of a PRO dossier for the Minnesota Living with Heart Failure Questionnaire and selection of a validated dyspnoea questionnaire
Content validity of a symptom endpoint and dossier in heart failure with preserved ejection fraction
Consultation on the validation of a primary clinical endpoint in heart failure
Chart review of heart failure in China
Meetings for a heart failure study
Heart failure chart review in China
Caregiver burden in patients with chronic heart failure
Psychometric validation of the chronic heart failure (CHF) caregiver burden questionnaire
Support for additional translations of the Heart Failure Compliance Questionnaire (HFCQ) for chronic heart failure
Network meta-analysis of pharmacological treatment of heart failure
Selection of a caregiver burden questionnaire for acute decompensated heart failure