TransCelerate and Tufts CSDD Uncover Opportunities to Rethink Data Collection and Optimize Protocol Design

New Study Finds Limited Value From Nearly One-Third of Clinical Trial Procedures and Associated Data, Highlighting Opportunity for More Patient-Centric Trial Design

PHILADELPHIA, Sept. 15, 2025 /PRNewswire/ -- TransCelerate BioPharma (TransCelerate), a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying clinical research, today announced the results of a new collaborative study with the Tufts Center for the Study of Drug Development (Tufts CSDD), Tufts University School of Medicine, that reveals opportunities to reduce participant and site burden in clinical trials through smarter, more efficient data collection.

The manuscript, titled "Insights Informing Strategies for Optimizing the Collection of Clinical Trial Data," has been submitted to Therapeutic Innovation & Regulatory Science (DIA TIRS) and is now publicly accessible via pre-print here. Findings from this study will be shared in a keynote presentation, "New Insights on Optimizing the Collection of Protocol Data," at the DPHARM: Disruptive Innovations to Advance Clinical Trials Conference on Wednesday, September 17, 2025, from 8:15 to 8:40 a.m.

The study was designed to analyze the volume, purpose, and impact of data collected in clinical trials — particularly data stemming from non-core and non-essential procedures — and to identify opportunities to optimize protocol design. Drawing on data from 105 Phase II and III protocols across 14 biopharmaceutical companies, the study finds that nearly one-third of procedures and the associated data collected doesn't directly support primary objectives or key secondary endpoints. While overall data volume continues to climb — Phase III protocols now average 5.96 million data points — these lower-value data contribute significantly to the site workload and patient participation burden.

"Sponsor companies face a myriad of pressures to gather increasing amounts of clinical trial data. The results of this study provide compelling insights informing future data collection strategies," said Kenneth Getz, Executive Director of Tufts CSDD and lead author of the study. "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 supports recent updates to ICH E6 R3 guidelines, which encourage fit-for-purpose data collection to reduce unnecessary complexity and burden while maintaining trial quality.

This collaborative study updates benchmarks on the incidence of non-core procedures — those not directly supporting primary or key secondary endpoints — and introduces a new baseline measure on the incidence of non-essential procedures, those performed more often than scientifically necessary. Together, these types of procedures account for:

• Up to 32.5% of Phase III data collected per patient
• 25–30% of total burden on trial participants and investigative sites
• Significant inefficiencies in non-oncology trials, where up to 40% of patient-level data falls into these categories

The study shows that clinical trial datasets often contain large volumes of lower-priority data, adding unnecessary complexity for sites and participants. Although 77% of non-core data appears in Clinical Study Reports (CSRs), much of it is exploratory or intended for future use and not actively analyzed, raising questions about the need for early-stage collection.

"This study gave us a chance to address a critical question: Are we collecting the right data for the right reasons?" said Laura Galuchie, Senior Director, TransCelerate Program Lead, Oversight Committee, Merck. "Our findings bring fresh insight into the growing complexity of clinical trials and how it affects site burden, patient experience, and overall study conduct. Most importantly, these insights are helping us identify routes to help sponsors be more intentional about the data they collect. Smarter data strategies aren't just better science — they're essential for more efficient, equitable, and patient-friendly research."

TransCelerate's Optimizing Data Collection team is already working to develop tools and frameworks to help R&D organizations assess the scientific, regulatory, and operational utility of the data they collect. The goal is not to eliminate entire categories of data collection, but to make sure every data point contributes to scientific, regulatory, or patient-centered goals.

The complete study has been submitted for publication and will be available pending journal acceptance.

About TransCelerate BioPharma Inc.
TransCelerate BioPharma (TransCelerate) is a nonprofit organization that fosters collaboration across the global biopharmaceutical research and development community to simplify clinical trials and help bring new treatments to patients faster, safer, and more efficiently.

Headquartered in the Philadelphia area, TransCelerate has 20 member companies and a robust portfolio of initiatives focused on transforming connectivity, enabling information sharing and reuse, and driving innovative trial designs. For more information, please visit transceleratebiopharmainc.com.

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SOURCE TransCelerate BioPharma