Talk:Randomized controlled trial/Draft

Recruitment?

I wonder if this needs some detail on ethical recruitment, certainly the level in the Declaration of Helsinki, and perhaps examples from 21CFR11 U.S. regulations. The role of an Institutional Review Board probably should be considered. Howard C. Berkowitz 00:38, 19 April 2009 (UTC)

I think some of this would help, I do not know this area as well though. Ok to add to later editions? Robert Badgett 01:38, 29 April 2009 (UTC)

Publication bias

Publication bias refers to the tendency that trials that show a positive significant effect are more likely to be published than those that show no effect or are inconclusive. The Merck affair is not a case of publication bias, but raises different but interesting issues. The core issue here is related to the predetermined schedule of the trial. For statistical rigor, it is important that the parameters of a trial, including the end date, be predetermined - it cannot be left open to the organisers when they choose to end the trial because of the natural temptation to stop the trial at a point when the results appear consistent with a hoped for outcome. The dispute in the Merck case arose because of adverse events that occurred after the prescheduled end date, and so were not included. The authors argued that to do so would invalidate the prospective statistical design; the objections were that the publication should have disclosed adverse events known to have occurred subsequently. The arguments though are complex

Except for this issue, I think the article is excellent and I'm happy to support approval.12:15, 28 April 2009 (UTC)

I saw Merck as a variation of publication bias in that Merck suppressed negative data. However, I see your point. I removed this statement and replaced it with your first sentence above - which is succinctly worded. ok? - Robert Badgett 01:31, 29 April 2009 (UTC)

Thanks, added my name to To approve. Well done RobertGareth Leng 08:25, 7 May 2009 (UTC)