Salim Yusuf
Monitoring clinical trials that evaluate the effectiveness and safety of a treatment or intervention is key to ensuring data accuracy, ethical conduct, and participant safety. The ‘PHRI Boundary’ offers a practical and easy-to-implement method for monitoring trial efficacy, balancing safety, and maintaining the trial’s integrity.
Salim Yusuf, PHRI Founder and Emeritus Executive Director and Senior Scientist, and Shrikant Bangdiwala, PHRI Director of Statistics and Senior Scientist, recently published a breakthrough manuscript providing the statistical methodological justification for the PHRI Boundary used for interim analyses.
Shrikant Bangdiwala
In clinical trials, independent bodies like the Data and Safety Monitoring Board (DSMB) conduct interim analyses to review the collected data and determine whether the trial should continue or end early. The PHRI Boundary method is pragmatic as it takes into consideration the typical monitoring behavior of monitoring bodies of large multicenter trials and is relatively easily implemented.
This method has already been successfully used in two completed PHRI trials: HOPE and COMPASS. Both trials were terminated early due to significant results, guided by this monitoring approach.
Read the full manuscript “Pragmatic monitoring of emerging efficacy data in randomized controlled trials.”
