COA regulatory submissions and support
Appropriate clinical outcome assessment (COA) label claims rely on robust instrument selection, development and validation in the targeted Context of Interest and to a standard that meets current regulatory expectations. Regulatory approval is dependent on assessment of relevant and important outcomes (the ‘concept of interest’) in the right population (‘context of use’) to capture the true treatment benefit.
As leaders in Patient-Centered Outcomes, Adelphi Values are highly experienced in developing COA dossiers and other regulatory briefing books that are in line with the expectations of the FDA COA Staff (formerly known as SEALD), facilitating efficient and productive regulatory interactions, and ultimately helping clients to gain approval for targeted label claims.
Our senior team brings years of experience to the table in helping to deliver regulatory success through strategic consulting, development of dossiers and briefing books, regulatory meeting support and attendance and more.
Example solutions that we provide to help achieve regulatory success include:
- FDA Type B / C meeting support and attendance
- FDA advisory committee meeting support and attendance
- FDA briefing documents
- EMA common technical documents
- PRO/COA evidence dossiers
- Labeling strategy
- Consulting related to regulatory interactions and submissions
- Evidence synthesis for regulatory submissions
Examples of quotes from the minutes of FDA meetings that Adelphi Values have been involved with in the last two years include:
“The concept elicitation research is complete and adequately explores the areas of pain…”
“The sample for concept elicitation was adequate… The FDA concurs with the proposed recall period and reporting frequency.”
“Does the Agency concur with the proposed plans for psychometric evaluation? ‘Overall, yes. FDA appreciates the Sponsor’s discussion of ensuring the instruments’ ability to detect change.’”
“We agree with the sponsor’s plan to employ a mixed methods approach using Rasch analysis in addition to other methods to establish content validity.”
“The Sponsor’s work demonstrates the content validity of the items and domain.”
“In general, we have found your qualitative work to date complete, well-executed and carefully analysed.”
Our regulatory successes in approved products
Contact our experts:
Rob Arbuckle | Managing Director UK, Patient-Centered Outcomes
Alan Shields | President US, Patient-Centered Outcomes