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Has FDA's Drug Development Tools Qualification Program Improved Drug Development?

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Area of Science:

  • Drug Development
  • Regulatory Science
  • Clinical Outcome Assessments

Background:

  • The Drug Development Tools (DDTs) Qualification Program evaluates Clinical Outcome Assessments (COAs) for use in drug development.
  • Qualified COAs aid regulatory decision-making by measuring specific concepts of interest.
  • This analysis assesses FDA's review performance and the adoption of qualified COAs.

Purpose of the Study:

  • To evaluate the U.S. Food and Drug Administration's (FDA's) performance in reviewing applications within the Clinical Outcome Assessment (COA) Qualification Program.
  • To assess the extent to which qualified COAs have been adopted and utilized in drug development.

Main Methods:

  • Analysis of FDA's Summary Basis of Approvals (SBA) and COA compendium.
  • Retrieved submission and review timelines for Qualification Plan (QP) and Full Qualification Package (FQP) from FDA databases.
  • Examined FDA COA Qualification Program website data.

Main Results:

  • 86 COAs are listed, mostly Patient Reported Outcomes (PROs).
  • 46.7% of submissions exceeded target review times; average qualification takes 6 years.
  • Only 7 COAs (8.1%) qualified, with 3 used in 11 drug approvals, primarily as secondary endpoints.

Conclusions:

  • Lengthy and unpredictable review timelines risk tool developers and sponsors.
  • The DDT Qualification Program has limited impact on integrating qualified COAs into clinical development.
  • FDA should share timelines and clarify COA usage for improved program utility.