A new report by an independent research group gives the U.S. Food and Drug Administration (FDA) generally good marks for the way the agency is currently using patient experience data to make regulatory decisions.
The FDA has contracted Eastern Research Group, Inc. (ERG) to perform this initial assessment and produce the report. ERG assessed document reviews for new drug applications (NDAs), biologics license applications (BLAs), and efficacy supplements, and conducted interviews with FDA staff, applicants, and external stakeholders (patients, nurses, clinicians, advocacy / research organizations).
The assessment gathered information to answer three questions:
- How does the FDA use patient experience data in regulatory decisions?
- How do FDA staff, applicants, and external stakeholders characterize (a) the use of patient experience data in regulatory decisions, and (b) the communication with the FDA about the use of that data?
- What are the best practices and opportunities for improvement for (a) the use of patient experience data in regulatory decisions, and (b) FDA communications about the use of that data?
ERG’s report provides details on the methods used to identify, collect, and analyze data for this assessment, outcomes, and key outcomes. It also includes recommendations to the FDA on how to better communicate and expand the use of patient experience data in regulatory decisions, and to external stakeholders on how to use best practices to support the FDA’s acceptance of patient experience data.
For example, the report provides some ideas on how the FDA and industry can be more consistent about “whether and how” the agency uses patient experience data in making decisions about whether or not to approve applications.
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The Report’s Recommendation for Applicants: If you are pursuing a drug / biological development program, consult FDA guidelines and FDA staff early and frequently to understand the potential value of patient experience data, types of data to be developed, appropriate tools to use, approaches to collection Data and a data analysis plan.
The report’s recommendation to the FDA: Continuation or expansion of collaborative programs to promote the development of patient-centered drug development tools and clinical outcome assessments. Providing internally and externally models of applicant development and presentation of patient experience data in marketing proposals and the FDA’s use of this data in various therapeutic contexts. Encourage the exchange of additional examples of the use of patient experience data in regulatory decisions within and between examining departments.
Modifications made by Michael Causey