(Original presentation by Hugh Harricks)
Many randomised, controlled trials have been retracted after publication because of data fabrication and inadequate ethical approval. The most retracted medical journal author (to date…) is a Japanese anaesthetist.
The Calisle Method or Monte Carlo Analysis calculates the likelihood that the distribution of a data set is improbable.
Some p values were so extreme that the baseline data could not have been correct: for some trials the probability was less than 1 in 1015 – equivalent to one drop of water in 20,000 Olympic-sized swimming pools!
Unintentional error, correlation, stratified allocation and poor methodology might well contributed to this distortion.
Identification of large numbers of fraudulent RCTs may have significant impact on meta-analyses and systematic reviews on topics such as PONV and Colloids.
Investigations, retractions and reanalysis are ongoing and this discovery may only be the tip of the science fraud iceberg.
Anaesthesia now screens all submitted RCTs. Cochane will also be reviewing all of their meta-analysis work.