Patient and Caregiver
Investigator
Regulator
IRB
Tech, Device,
PayerTrial Design Stage
Published Date: October 6, 2023
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Helpful Terms and Definitions
Study Concept
Questions To Ask
- Does the study align with established best practices, clinical guidelines, or standards of care for the target disease or condition?
- If there isn't a proven standard of care, how will this study demonstrate the effectiveness of the investigational treatment over other existing treatments?
- What will be the benefit for patients if the investigational treatment is approved? Will it contribute to better care practices, improved clinical outcomes, or more effective disease prevention strategies?
- What populations are affected by the target disease or condition? Are there social risk factors that could affect access to care?
- How can payers and sponsors work together to ensure equal access to the investigational treatment across the affected population?
Why involve Payers now?
Early payer engagement at the study concept phase helps ensure clinical trials generate evidence that supports downstream access, reimbursement, and formulary decision‑making. Building these relationships early fosters trust between sponsors and payer groups and maximizes the long‑term value of the clinical development program—engagement that should continue throughout trial design.
Payers provide critical insight into which clinical and economic endpoints matter most, including cost‑effectiveness, quality of life, and patient‑reported outcomes. Their perspective helps ensure appropriate comparators are included and that trial designs reflect how new therapies will be assessed against existing standards of care.
In addition, payers can advise on health economic models that best demonstrate budget impact and value, help define patient populations that mirror real‑world use, and recommend data collection approaches—such as real‑world evidence and long‑term follow‑up—that align with payer evidence expectations. Their guidance on regulatory standards and result communication further strengthens the credibility, relevance, and acceptance of trial outcomes.
How to locate a Payer group
Leverage your existing professional networks, including colleagues, industry associations, and conferences. Networking events and industry meetings can be valuable for making connections with payer representatives.
What can Payers contribute to the clinical research enterprise?
- Encouraging dissemination of medical technologies that have been proven safe and effective
- Encouraging the implentation of evidence-based clinical guidelines and best practices
- Supporting clinical research independently and through sponsor partnerships
- Helping put clinical research findings into practice through disease management efforts and provider education initiatives
- Disseminating health information through health education programs