Strategies to optimize generation of patient-reported outcomes to support the value proposition to regulators, reimbursement agencies, and patients.
Data that reflect the patient experience of disease and treatment beyond global HRQL are becoming increasingly important to inform decision-making by a broad range of stakeholders, from regulators and payers through to clinicians and patients. Patient-centered outcomes data are thus an invaluable element of the value proposition and can support differentiation.
We work with our clients to develop and execute a strategy to generate patient-centered outcomes data that meet the demands of multiple interested stakeholders, as part of the overall value proposition and evidence generation program. This can range from recommendations on endpoint selection and instrument choice through to development and validation of instruments.
- Early identification of relevant endpoints and instruments, which could be patient-reported, clinician-reported, or observed outcomes
- Integration of data collection and analysis into the clinical trial program to maximize efficiency
- Scientifically rigorous methodology that supports publication of data
- Development and validation of instruments to support regulatory labeling