We optimised a cost-effectiveness model that initially lacked resonance and failed to demonstrate cost-effectiveness.
Real world evidence
Real world data can offer important insights into treatment implementation and the acceptability, efficacy and safety of products relative to existing standard of care.
Real world evidence (RWE) can be used to delineate the natural history of a disease, determine unmet need and describe treatment pathways in different countries and clinical settings. With our knowledge and experience of an array of different datasets, we can help identify the most robust RWE for your needs. We can design studies to generate real world evidence to inform clinical strategy, enhance market access and support regulatory and HTA submissions.
Design and analysis of real world evidence studies
RWE can provide important insights throughout the product lifecyle from helping to achieve market access and product uptake through to supporting marketing strategy once commercialized. Examples of our services include:
- Evaluating the comparative safety, efficacy, uptake and adherence of products in a real world setting
- Constructing external comparator arm for treatment option/best supportive care to enhance clinical trial(s)
- Determining treatment patterns and pathways in different regions and clinical settings
- Quantifying associated costs of care to populate health economic models
- Describing the burden of illness to determine unmet clinical need
- Designing studies and analysing data from rare disease populations
Disease natural history models
Understanding the natural history of a disease is essential for designing studies that assess the impact of interventions on patient outcomes. In addition, biomarkers of disease progression may provide surrogate outcomes for clinical trials. However, collecting and visualizing data on natural history is challenging due to the complexity of disease processes, and may require combination of multiple population samples. We can help identify the most appropriate epidemiological design, data source and analysis to elucidate the natural history process.
Case studies
We developed a comprehensive market access strategy to support HTA and reimbursement submissions for a product with a unique mode of action, whose benefits were only partially reflected in clinical trials.
We addressed the challenge of estimating survival advantage for an innovative treatment with no European-standard comparator and high crossover in pivotal trial.
