A newly completed study from Tufts CSDD revealed that phase III clinical trials currently produce an average of 3.6 million data points, which is three times more than late-stage trials conducted a decade ago. According to Ken Getz, a professor and director of Tufts CSDD, this increase is a result of biopharmaceutical companies engaging in more ambitious and customized drug development activities that specifically target rare diseases, involve stratified participant subgroups using biomarker and genetic data, and rely on both structured and unstructured patient data from a wider range of sources.

Getz further emphasized that drug developers will need to enhance their data management strategies and tactics, including real-time interim assessment, risk-based approaches, automation, and augmented analytics to support scientific and operational decisions. The study also updated previous benchmarks and established new baseline measures based on 220 recently completed protocols targeting various therapeutic areas worldwide.

Key findings of the research included a 44% increase in the mean number of distinct Phase II and III protocol procedures since 2009, and a 33% rise in the average number of investigative sites conducting Phase II and III protocols from 2009-12 to 2017-20. This data highlights the growing complexity and scale of clinical trials in recent years.