A new collaborative study from TransCelerate BioPharma and the Tufts Center for the Study of Drug Development (Tufts CSDD) suggests that large volumes of clinical trial data add limited value and contribute significantly to site and patient burden.

The research, conducted on 105 phase 2 and phase 3 protocols from 14 biopharmaceutical companies, shows that up to 32.5% of patient data in phase 3 trials comes from procedures not directly supporting primary or key secondary endpoints. These non-core and non-essential procedures account for 25–30% of workload for participants and investigative sites. In non-oncology trials, the figure rises to as much as 40%.

The study also highlights the escalating complexity of data collection in clinical trials. While the volume of data continues to climb — with phase 3 protocols now averaging 5.96 million data points — the analysis shows that much of this data is exploratory or collected for potential future use. Around 77% of non-core data ends up in Clinical Study Reports, but the majority is not actively analyzed.

Kenneth Getz, executive director of Tufts CSDD and lead author of the study, said: “Sponsors now have evidence to help transform legacy protocol design and execution practices, and help improve clinical trial performance, efficiency, site, and patient participation.”

The study, Insights informing strategies for optimizing the collection of clinical trial data, has been submitted to Therapeutic Innovation & Regulatory Science and is available as a preprint. The findings will be presented at the DPHARM conference in Philadelphia on Sept. 17, 2025.

The authors argue that these results highlight a need for sponsors to reassess which data points are scientifically necessary. Excessive collection increases the burden on patients — who may have to undergo repeated tests — and on trial sites that must manage, store, and report vast datasets. Although the practice of capturing additional data is often justified as a way to future-proof studies, the findings suggest that much of it rarely informs regulatory or clinical decision-making.

Laura Galuchie, senior director and TransCelerate program lead at Merck, said: “This study gave us a chance to address a critical question: Are we collecting the right data for the right reasons? Our findings bring fresh insight into the growing complexity of clinical trials and how it affects site burden, patient experience, and overall study conduct.”

The study aligns with recent updates to ICH E6 R3 guidance, which encourage fit-for-purpose data collection. TransCelerate’s Optimizing Data Collection team is developing frameworks to help research organisations assess the scientific, regulatory and operational utility of data collected. The aim is not to eliminate entire categories of data but to ensure each data point contributes meaningfully to trial objectives or patient-centered outcomes.

The complete study will be available pending journal acceptance.