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Area of Science:

  • Clinical Research
  • Patient-Centricity
  • Drug Development

Background:

  • Investigative site burden in clinical trials is well-documented.
  • However, patient burden in clinical trials remains under-quantified.
  • This study addresses the gap in understanding patient-reported trial burden.

Purpose of the Study:

  • To quantify patient burden in clinical trials.
  • To assess the relationship between patient burden and clinical trial performance.
  • To identify factors contributing to patient burden.

Main Methods:

  • A cross-sectional pilot study surveyed nearly 600 patients on the perceived burden of 60 common clinical trial procedures.
  • Patient burden was aggregated and correlated with performance metrics for 137 clinical protocols.
  • Statistical analyses included descriptive statistics, significance tests, and univariate analyses.

Main Results:

  • A significant positive association was found between composite patient burden scores and clinical trial performance.
  • Higher patient burden strongly correlated with increased study conduct duration (first to last patient).
  • Increased number of study visits beyond the tolerable mean was a key factor in patient burden.

Conclusions:

  • Patient burden is a critical, quantifiable factor in clinical trial success.
  • Optimizing clinical trial design to reduce patient burden can improve engagement and performance.
  • This approach offers a new strategy for enhancing clinical trial efficiency and patient experience.