PRO/COA strategy

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:

  • Help you measure what really matters to patients, their clinicians, and their caregivers
  • Inform target product profiles (TPP) and identify relevant measurement concepts
  • Facilitate regulatory approvals and help you obtain PRO label claims
  • Demonstrate product differentiation through the patients’ perspective
  • Generate evidence to meet the needs of multiple stakeholders including regulators, payers, and clinicians

Our expertise

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.

Our methods

The COA team’s specific methods for PRO/COA measurement strategy and patient insight development include:

  • Literature reviews
  • Instrument reviews
  • Qualitative research (interview, focus groups) with patients, clinicians, and caregivers
  • Quantitative research, including online surveys
  • Mixed methods research
  • Online research including social media review and group concept mapping
  • Innovative, creative methods research for specific populations (e.g. paediatrics, rare diseases)

We are part of Decision Resources Group (DRG), a subsidiary of Piramal Enterprises Ltd.

DRG offers best-in-class, high-value data, analytics and insights products and services to the healthcare industry, delivered by more than 1,000 employees across 17 offices in North America, Europe and Asia.

Our Company
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