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Adverse event reporting in clinical trials: room for improvement

Winston S Liauw and Richard O Day
Med J Aust 2003; 179 (8): 426-428.

Summary

  • Regulatory and ethical guidelines require clinical trial sponsors to disseminate clinical trial adverse event reports to involved investigators and human research ethics committees.

  • Compliance with these guidelines has resulted in a major administrative burden for ethics committees.

  • This burden does not necessarily contribute to the protection of clinical trial participants.

  • Rationalisation of the adverse event reporting might allow better use of the data and might benefit human research ethics committees.

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  • Winston S Liauw1
  • Richard O Day2

  • St Vincent’s Hospital, Darlinghurst, NSW.

Correspondence: 

Acknowledgements: 

We thank Mr Rodney Ecclestone, Executive Officer, St Vincent’s Hospital (Sydney) Human Research Ethics Committee, and Ms Barbara Yeung, Clinical Trials Centre, St Vincent’s Hospital, for helpful discussions concerning the adverse event reporting process.

Competing interests:

None identified.

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  • 5. Report of the review of the role and functioning of institutional ethics committees. Report to the Minister for Health and Family Services. Canberra: AGPS, 1996.
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  • 7. Goldberg RM, Sargent DJ, Morton RF, et al. Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group’s Real-Time Toxicity Monitoring Program. J Clin Oncol 2002; 20: 4591-4596.
  • 8. Institutional Review Boards: the emergence of independent boards. Washington, DC: US Department of Health and Human Services, Office of Inspector General, 1998: 1-18. (Publication No. OEI-01-97-00192). Available at: oig.hhs.gov/oei/reports/oei-01-97-00192.pdf (accessed Aug 2003).

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