Rutgers School of Public Health professors Dr. Weichung Joe Shih and Dr. Yong Lin have compared the efficiency of marker-stratified treatment trials with precision medicine designs. Prospective randomized clinical trials that address the use of biomarkers for precision medicine are both time consuming and expensive; however, trials are required for regulatory agencies to approve new treatment plans with predictive biomarkers.
Based on their research in design’s efficiency, Dr. Shih and Dr. Lin noted that marker-stratified design is much more efficient in all hypotheses of clinical interest than marker-based strategy designs. Accordingly, they recommend the use of marker-stratified designs. This finding has great impact on the clinical trial methodology in modern precision medicines.
“On study designs and hypotheses for clinical trials with predictive Biomarkers” was published in Contemporary Clinical Trials. “Relative efficiency of precision medicine designs for clinical trials with predictive biomarkers” was published in Statistics in Medicine and presented at the International Biometrics Society 2018 Eastern North American Region (ENAR) Spring Meeting recently.