Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups.

Background: Benchmark data characterizing protocol design practices and performance informs clinical trial design decisions and serves as important baseline measures for assessing protocol design behaviors and their impact during and post-pandemic.

Methods: Tufts CSDD, in collaboration with a working group of 20 major and mid-sized pharmaceutical companies and CROs, gathered phase I-III data from protocols completed just prior to the start of the global pandemic.

Results: Data for 187 protocols were analyzed to derive benchmarks overall and for two primary subgroups: oncology vs.