Musculoskeletal diseases

Arthritis

  • Manuscript and analysis on an anti-inflammatory treatment for arthritis
  • PRO literature review for two different anti-inflammatory drugs for the treatment of arthritis

Ankylosing spondylitis

  • Interactive cost-effectiveness model for a selective inhibitor treatment used for ankylosing spondylitis
  • Manuscript cost-effectiveness analysis of a treatment for ankylosing spondylitis in Norway
  • Workshop and FAQ development in immunology in ankylosing spondylitis
  • Development of a payer value deck in immunology in ankylosing spondylitis
  • Competitor review deck in ankylosing spondylitis
  • Total Brand FAQ deck and Total Brand Workshop in ankylosing spondylitis
  • Global value dossier and budget impact model for a biosimilar in ankylosing spondylitis
  • Competitor value story slide deck in ankylosing spondylitis
  • Payer slide kit in non-radiographic axial spondyloarthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on ankylosing spondylitis

Juvenile idiopathic arthritis

  • Workshop and FAQ development in immunology in juvenile idiopathic arthritis
  • Development of a payer value deck in immunology in juvenile idiopathic arthritis
  • Frequently asked questions deck in juvenile idiopathic arthritis

Osteoarthritis

  • Global value dossier and budget impact model for a biosimilar in osteoarthritis
  • Literature review of PROs and endpoints of pain in osteoarthritis
  • Literature review to support the use of COA measures in osteoarthritis
  • Competitive assessment and burden of illness study in osteoarthritis
  • Review of endpoints for clinical trials in osteoarthritis
  • Instrument review and assessment strategy in osteoarthritis
  • Mixed treatment comparison of two treatments for osteoarthritis of the knee
  • Mode of administration validation study for an electronic diary in back pain for osteoarthritis patients
  • Development and cognitive debriefing on a patient global response to a treatment measure in osteoarthritis pain
  • Translation and validation of the revised Hopkins Verbal Learning Test for osteoarthritis
  • Translation and validation of an osteoarthritis diary
  • Development of a measure of disease flare in osteoarthritis patients
  • Patient interviews to capture disease burden and unmet treatment needs in hand osteoarthritis
  • Mode of administration equivalency and usability testing of COA instruments in osteoarthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on osteoarthritis
  • Consulting on PRO analysis and study design of trials in osteoarthritis
  • Top up literature review of PROs in osteoarthritis
  • Gap analysis and review of PRO measures in osteoarthritis
  • Qualitative exit interviews to assess the patient experience of treatment and clinical trial participation among patients with osteoarthritis

Psoriatic arthritis

  • Payer dossier update in psoriatic arthritis
  • Support for a manuscript on a network meta-analysis in psoriatic arthritis
  • Systematic literature review and network analysis in psoriasis and psoriatic arthritis
  • Targeted literature review in psoriatic arthritis patients with concomitant moderate to severe psoriasis
  • Workshop and FAQ development in immunology in psoriatic arthritis
  • Development of a payer value deck in immunology in psoriatic arthritis
  • Competitor review decks in psoriatic arthritis
  • Competitor value story slide deck in psoriatic arthritis
  • Data checks and DEF amendments in psoriatic arthritis
  • HTA support regarding psoriatic arthritis submissions in Canada, Spain and the UK
  • Regulatory support on SMC questions on psoriatic arthritis work
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of psoriatic arthritis

Rheumatoid arthritis

  • Literature search, data extraction and report on rheumatoid arthritis
  • Cost-consequences manuscript on rheumatoid arthritis
  • Generating evidence to support the unmet need in rheumatoid arthritis
  • Measuring indirect and societal costs of morning stiffness in patients with rheumatoid arthritis
  • Manuscript on a treatment in rheumatoid arthritis
  • Review of an economic model to assess utility requirements for a treatment in rheumatoid arthritis
  • Utility study and economic model in rheumatoid arthritis
  • Review of European HTA requirements for treatment in rheumatoid arthritis
  • Adaptation of an economic model on treatment of rheumatoid arthritis for the USA
  • Value message testing for a biosimilar in rheumatoid arthritis
  • Objection handler in rheumatoid arthritis
  • Economic model on a treatment for rheumatoid arthritis
  • Budget impact model for a biosimilar in rheumatoid arthritis
  • Competitor review in rheumatoid arthritis
  • Competitor review of two JAK inhibitors in rheumatoid arthritis
  • Payer focused value communication on rheumatoid arthritis
  • Payer value proposition update in rheumatoid arthritis
  • Frequently asked questions on an immunology biosimilar for rheumatoid arthritis
  • Literature review of unmet need in rheumatoid arthritis
  • Literature review and recommendations for rheumatoid arthritis
  • Utility study in rheumatoid arthritis
  • Competitor value story in rheumatoid arthritis
  • Competitor value stories for two treatments of rheumatoid arthritis
  • Manuscript on a budget impact model for a cross-indication biosimilar in conditions including rheumatoid arthritis
  • Core value dossier, value deck and objection handler in rheumatoid arthritis
  • Update to an AMCP dossier for a rheumatoid arthritis biosimilar
  • Global value dossier and budget impact model for a biosimilar in rheumatoid arthritis
  • Workshop and FAQ development in immunology in rheumatoid arthritis
  • Development of a payer value deck in immunology in rheumatoid arthritis
  • Total Brand FAQ deck and Total Brand Workshop in rheumatoid arthritis
  • Review of PROs and preparation and writing of a PRO briefing document for the FDA on the treatment of rheumatoid arthritis
  • Generation of evidence to support the unmet need in rheumatoid arthritis
  • Modified Delphi Panel to gain consensus in rheumatology (rheumatoid arthritis)
  • Development of a PRO strategy in rheumatoid arthritis
  • Qualitative research in rheumatoid arthritis
  • Poster and manuscript on an indirect comparison of biologic treatments for TNF-IR rheumatoid arthritis patients
  • Systematic review to explore minimal important differences in PROs for rheumatoid arthritis
  • Meta-analysis of joint structural deterioration over time in minimally treated rheumatoid arthritis patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR)
  • Mixed treatment comparison of efficacy and safety of an immunosuppressant drug versus a TNF inhibitor drug in rheumatoid arthritis patients with DMARD-IR
  • Mixed treatment comparison of an oral drug used in the treatment of rheumatoid arthritis
  • Characterising and predicting treatment response to rheumatoid arthritis biologic therapy
  • Literature review of unmet need in rheumatoid arthritis
  • Mixed treatment comparison of a treatment for rheumatoid arthritis populations – DMARD-IR and MTX-naive patients
  • Q&A and mixed treatment comparison on a treatment for rheumatoid arthritis
  • Indirect comparison of a monotherapy treatment for rheumatoid arthritis patients with DMARD-IR
  • Face and content validity testing of a tiredness item in a sample of rheumatoid arthritis patients
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis
  • Psychometric evaluation of a PRO in rheumatoid arthritis
  • Evaluation of fatigue in rheumatoid arthritis using a PRO instrument
  • Patient interviews on rheumatoid arthritis
  • Patient interviews to capture disease burden and unmet treatment needs in rheumatoid arthritis
  • Support in development and analyses of a patient support programme in indications including rheumatoid arthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on rheumatoid arthritis
  • Top up literature review of PROs in rheumatoid arthritis
  • Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis

Cervical dystonia

  • Validation and reliability of the Pictorial Spasmodic Torticollis Rating Scale (P-STRS) in cervical dystonia
  • Development of a screening tool in cervical dystonia (Delphi panel) and validate using registry
  • Validation of a screening tool in cervical dystonia
  • Measurement strategy in cervical dystonia
  • Content validity of global questionnaires in cervical dystonia

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

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

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

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

Muscle wasting

  • COA review and development for muscle wasting associated with chronic illness
  • Exit interviews to explore patient disease burden, treatment satisfaction and clinical trial participation in muscle wasting associated with chronic obstructive pulmonary disease (COPD)
  • Qualitative research to support the identification of key impacts on physical functioning and activities of daily living in patients with muscle wasting

Musculoskeletal pain

  • Conference abstract and poster for early decision modelling in acute pain
  • Strategic literature review of chronic pain
  • Competitive assessment and burden of illness in chronic low back pain
  • Content confirmation and testing of the Roland Morris Disability Questionnaire (RMDQ) and Pain NRS Personal Digital Assistant in chronic low back pain
  • Development of a responder index in low back pain
  • Manuscript on the chronic low back pain responder index
  • Development of a PRO measure of stiffness in acute low back pain
  • Focus group interviews with patients with chronic low back pain
  • Gap analysis and strategic recommendation for PRO and market access studies in chronic low back pain and diabetic peripheral neuropathy
  • Mode of Administration (MOA) equivalency study in lower back pain
  • Consulting on PRO analysis and study design of trials in chronic low back pain
  • Burden, economics, epidemiology and treatment patterns in chronic low back pain
  • Qualitative exit interviews to assess the patient experience of treatment and clinical trial participation among patients with chronic low back pain
  • Gap analysis and review of PRO measures in low back pain and neck pain
  • Development of a briefing document on the modified Brief Pain Inventory – Short Form (mBPI-SF) in acute musculoskeletal pain
  • Critical review of PRO instruments in fatigue and pain in rheumatic disease
  • PRO literature review in pelvic pain
  • Patient perspective literature review for chronic pelvic pain in both men and women

Osteoporosis

  • Manuscript support for a screening model in osteoporosis in Japan
  • Cost-effectiveness model in osteoporosis
  • Cost-effectiveness analysis of a medicine used for the treatment of osteoporosis
  • Assessing the clinical gap by incorporating bone mineral density (BMD) screening into the annual health check-ups for osteoporosis in Japan
  • Indirect comparison of two treatments for non-vertebral fractures in osteoporosis

Other musculoskeletal experience

  • Economic analysis and trial design in hip replacement
  • Payer value slide deck in muscle relaxation management
  • Manuscript on a budget impact model for a biosimilar in rheumatology
  • General consultancy on economic and quality of life endpoints in planned trials in several musculoskeletal disease indications
  • Measurement strategy to demonstrate efficacy of medical devices in patients with pigmented villonodular synovitis (PVNS) or tenosynovial giant cell tumour (dTGCT)
  • Review adherence questionnaire in a musculoskeletal disease

Spasticity

  • Conference abstract on spasticity
  • Top up literature review in paediatric lower limb spasticity
  • Development and validation of a physician-administered diagnostic tool for spasticity
  • Validation of a screening/consensus tool in spasticity
  • Concept confirmation and cognitive debriefing of spasticity PRO measures in post-stroke spasticity (PSS) patients, and development of spasticity screener
  • Mechanism of Action (MOA) Equivalency Testing of the SIA and SSA in post-stroke spasticity patients
  • Poster for Post-Stroke Spasticity (PSS) PRO
  • Consolidation of Post-Stroke Spasticity (PSS) development reports for FDA submission