Post-trial period surveillance for randomised controlled cardiovascular studies: submitted protocols, consent forms and the role of the ethics board
Journal of Medical Ethics, 07/22/2011
Exclusive author commentary
Zia MI et al. – The majority of protocols and consent forms did not discuss plans for post–trial period surveillance. The post–trial period and the research ethics boards (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.
Mohammad I Zia (07/25/2011) comments:
Our observational study suggests that post-trial arrangements for patient surveillance are not routinely included in study protocols and consent forms. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form.