Relevant or Not? Rethinking What Data Clinical Trials Collect

Author(s): Laura Galuchie & Ken Getz

Phase 3 clinical trials now collect an average of nearly 6 million data points per protocol. That figure has grown by more than 280% over the past decade, increasing 11% annually since 2020. Within that volume is data that determines whether a drug works, whether it’s safe, and whether it earns approval. The rest—a substantial portion of it—is gathered from study participants, administered and processed by site staff, tracked across patient visits, and reported in documents, but is not relevant (see below) in supporting assessment of primary and key secondary efficacy and safety endpoints.

A collaborative study between TransCelerate BioPharma and the Tufts Center for the Study of Drug Development (Tufts CSDD), recently published in Therapeutic Innovation & Regulatory Science, quantified the distribution and rationale of protocol data volume to better understand this problem. The findings are difficult to set aside, and they have prompted TransCelerate’s Optimizing Data Collection (ODC) initiative team to move from diagnosis to action.