PADDI Trial wins ACTA-STInG Excellence in Trial Statistics award
The Australian Clinical Trials Alliance (ACTA) pays tribute to the outstanding contribution by people across the sector involved in investigator-led clinical trials on International Clinical Trials Day, which is held on May 20 each year. The ACTA-STInG (Statistics in Trials Interest Group) Excellence in Trial Statistics Award is adjudicated by a panel of senior statisticians for the trial that demonstrates exemplary statistical aspects across the life stages of the trial, from trial design and planning, to analysis, reporting and interpretation. This year, the prize was awarded to The Perioperative ADministration of Dexamethasone and Infection (PADDI) trial with the Trial Statistician, Prof Andrew Forbes, accepting the award on behalf of the PADDI trial group. This marks the second consecutive year that Prof Forbes' work has won this award.
The PADDI trial was a pragmatic randomised non-inferiority trial assessing the safety of 8mg dexamethasone versus placebo in terms of surgical site infection in 8880 patients undergoing non-urgent non-cardiac surgery across 55 centres in 4 countries. The results of the trial were published in the New England Journal of Medicine in 2021.
Andrew Forbes remarked that “Although superficially PADDI was a straightforward stratified individually randomised trial, in practice the non-inferiority design posed many challenges for the design and monitoring of the trial. First, the non-inferiority margin needed to be determined and agreed upon by the large investigator group, because the eventual trial results would ultimately be interpreted with respect to this margin. There were also challenges with respect to determining the asymmetric interim monitoring procedure in which more liberal boundaries were chosen for harm than for non-inferiority. Finally, with the trial likely to be of high clinical interest, the statistical analysis plan needed to be completely comprehensive and replete with sensitivity analyses in order to ensure the methods were transparent and results robust.”
Congratulations Andrew on this fantastic achievement (again!).