• By ICR Secretariat
  • Posted Thursday, June 22, 2017

Statistical analysis outlines level of data fabrication in some clinical trials


A statistical analysis of just over 5,000 randomised, controlled trials published in anaesthetic and general medical journals has found suspicious statistical patterns in some, raising concerns over the reliability of study outcomes.

The study, performed by John Carlisle, consultant, Department of Anaesthesia, Torbay Hospital, examined the distribution of data in 5,087 trials published in the Journal of the American Medical Association, the New England Journal of Medicine and six anaesthesiology journals over a 15-year period (from 2000 to 2015). Baseline summary data for continuous variables was taken from the papers, where ‘baseline’ was defined as a variable measure before allocated intervention was initiated.

Distribution of probability (p) values was the primary outcome of the analysis, which was noted in the paper as ‘calculated for differences between means, for individual variables and when combined within trials’. In a secondary analysis, Carlisle examined p values for those papers that had been retracted versus those that had not and compared the results.