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Most oral anticancer therapies collect patient-reported outcomes (PROs), but reporting rates at approval remain suboptimal. Further research is needed to improve timely PRO data availability for cancer therapies.

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Area of Science:

  • Oncology
  • Clinical Trials
  • Health Outcomes Research

Background:

  • The US Food and Drug Administration (FDA) issued guidance on patient-reported outcomes (PROs) in 2016, aiming to integrate them into clinical trials.
  • Despite progress, PRO data for many oral anticancer therapies are not reported at the time of FDA approval.
  • There is a need to enhance the collection and reporting of PRO data for oral anticancer therapies.

Purpose of the Study:

  • To quantify the availability rate of PRO data for oral anticancer therapies approved by the FDA between January 2018 and August 2023.
  • To identify factors influencing the reporting of PRO data in clinical trials for oral anticancer therapies.

Main Methods:

  • A retrospective, cross-sectional review of oral anticancer therapies approved by the US FDA.
  • Data collected from January 2018 to August 2023.
  • Descriptive data analysis and statistical tests performed using SPSS version 29.

Main Results:

  • 75% of FDA approvals included PRO data collection, with a median of three PROs per approval.
  • 69.7% of collected PROs were reported.
  • PROs collected as secondary objectives were more likely to be reported (80.1%) than those as exploratory objectives (52.6%).
  • Functional Assessment of Cancer Therapy (FACT) surveys showed the highest reporting rate (95.2%).
  • Subsequent PRO publications had a lower median impact factor (7.1) compared to initial publications (158.6).

Conclusions:

  • The majority of oral anticancer therapy trials collect PROs, indicating progress in data collection.
  • Opportunities exist to increase the availability of PRO data at the time of drug approval.
  • Further research is necessary to understand and optimize factors influencing timely PRO data reporting.