The clinical trial transparency in oncology significantly increased over the recent years

Seung Yeon Song1, EunYoung Kim2

  • 1Department of Health Science and Clinical Pharmacy, Chung-Ang University College of Pharmacy, Seoul, Republic of Korea.

Abstract

Insights

Oncology clinical trial transparency is improving, with significant increases in trial registration, prospective registration, and protocol disclosure over time. However, further enhancements in clinical trial reporting are still needed.

Area of Science:

  • Clinical Oncology
  • Medical Research Transparency
  • Scientific Publication Ethics

Background:

  • Clinical trial transparency is crucial for research integrity and reproducibility.
  • Efforts to enhance transparency include trial registration and protocol disclosure.
  • Assessing trends in these practices is vital for evaluating progress.

Purpose of the Study:

  • To analyze the extent and trends of registration, prospective registration, and protocol disclosure in oncology clinical trials.
  • To identify factors influencing these transparency measures.

Main Methods:

  • Systematic review of phase II and III oncology trials published between 2013-2017 in five major medical journals.
  • Data collection on trial registration status, prospective registration, and protocol availability.
  • Statistical analysis to determine trends and influencing factors.

Main Results:

  • 92% of trials were registered, with 76% prospectively registered; 27% provided protocols.
  • Significant increasing trends observed in registration, prospective registration, and protocol disclosure (P < 0.001).
  • Larger trials and non-industry funded trials showed specific patterns in registration and protocol disclosure.

Conclusions:

  • Oncology trial registration, prospective registration, and protocol disclosure have significantly increased.
  • Despite progress, opportunities remain to further improve clinical trial transparency in oncology research.

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