Clinical outcomes assessment (COA), including patient reported outcomes strategy (PRO strategy) can play a key role in the drug development process.
A strong COA strategy based on identifying and selecting the most appropriate outcome measures can:
At DRG Abacus, we have a dedicated COA team who have extensive methodological and commercial experience. The COA team have expertise in the development and validation of new and existing PROs and other COAs used to assess important patient outcomes, including symptoms, functioning, health-related quality of life (HRQoL), and treatment experience.
Our specialists are supported by a multidisciplinary team of medical writers, health economists, systematic reviewers and strategic advisors. Together, these experts provide integrated health economics and outcomes research (HEOR) and market access solutions across the product life-cycle.
We can provide a strategy for clients to measure the full efficacy and impact of their product. Our team can guide you in your selection of PRO/COA to be used in clinical trials, support content and psychometric validation of PROs/COAs for clinical trial endpoints, provide regulatory advice for sponsors seeking label claims based on PRO endpoints, and develop utility values for the assessment of cost-effectiveness. Through our bespoke research methods, we can also explore patient preferences relating to medication and devices, and help communicate unmet needs.
In an evolving climate where patient voice is increasingly recognised, our strategic advice helps assess the impact of your products on the people who matter the most.
The COA team’s specific methods for PRO/COA measurement strategy and patient insight development include:
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Read our case study to find out more about our expertise in developing a patient-centric clinical development programme for a pharma clientDownload
Read our case study to find out more about our expertise in identifying a suitable PRO strategyDownload