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Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board
  1. Mohammad I Zia1,
  2. Ronald Heslegrave2,
  3. Gary E Newton3
  1. 1Division of Cardiology, University of Toronto, Toronto, Canada
  2. 2Research Ethics Board, Mount Sinai Hospital and University Health Network, Toronto, Canada
  3. 3Department of Medicine, Mount Sinai Hospital and University of Toronto, Toronto, Canada
  1. Correspondence to Dr Mohammad I Zia, Division of Cardiology, 2075 Bayview Avenue, Room B327, Sunnybrook Health Sciences Centre, Toronto, ON, Canada M4N 3M5; mo.zia{at}utoronto.ca

Abstract

Background The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period.

Objectives The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance.

Methods An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded.

Results 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period.

Conclusions The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised.

  • Clinical trial
  • drug therapy
  • ethics
  • informed consent
  • scientific research

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Footnotes

  • Competing interests None declared.

  • Ethics approval This study was conducted with the approval of the Research Ethics Board, Mount Sinai Hospital, Toronto, Canada and the Research Ethics Board, University Health Network, Toronto, Canada.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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