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Related Experiment Videos

Stopping the active intervention: CARET.

Deborah J Bowen1, Mark Thornquist, Karen Anderson

  • 1Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA. dbowen@fhcrc.org

Controlled Clinical Trials
|February 1, 2003
PubMed
Summary
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The Carotene and Retinol Efficacy Trial (CARET) stopped early due to adverse effects. This lung cancer prevention study in smokers and asbestos-exposed workers informed participants and ensured continued follow-up.

Area of Science:

  • Oncology
  • Preventive Medicine
  • Clinical Trials

Background:

  • The Carotene and Retinol Efficacy Trial (CARET) was a significant clinical trial investigating lung cancer prevention.
  • The trial focused on high-risk populations: heavy smokers and individuals with asbestos exposure.

Purpose of the Study:

  • To detail the decision-making process for halting the CARET intervention due to adverse effects.
  • To describe the procedures for communicating trial cessation to participants and managing the transition.

Main Methods:

  • The CARET Steering Committee applied predefined stopping rules to assess intervention safety.
  • Participant communication involved direct notification about trial results and cessation of supplement intake.
  • Post-intervention follow-up was planned for disease endpoints and smoking behavior over five years.

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Main Results:

  • The intervention was terminated prematurely in January 1996 due to identified adverse effects.
  • Effective communication strategies were employed to inform participants and manage the trial's closure.
  • High participant retention rates were maintained during the transition from active intervention.

Conclusions:

  • The CARET trial's early termination highlights the importance of rigorous monitoring for adverse events in chemoprevention studies.
  • A structured approach to stopping rules and participant communication facilitated a smooth trial closure.
  • Continued follow-up of participants is crucial for understanding long-term outcomes after intervention cessation.