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Unlocking Potential: TransCelerate and Tufts CSDD

TransCelerate BioPharma, a nonprofit organization dedicated to accelerating clinical research globally, has partnered with the Tufts Center for the Study of Drug Development (Tufts CSDD) to shed light on data collection in clinical trials. Their collaborative study dives into current practices and presents opportunities to streamline processes—making clinical studies less burdensome for both participants and sites.

The Findings

A newly published manuscript titled "Insights Informing Strategies for Optimizing the Collection of Clinical Trial Data" reveals some intriguing statistics. Analysis covered data from 105 Phase II and III clinical trial protocols across 14 biopharmaceutical companies. Alarmingly, the study found that nearly one-third of the procedures and corresponding data collected do not directly support the primary and key secondary endpoints of the trials. Despite more data being accumulated, with average Phase III protocols reaching around 5.96 million data points, much of this additional data adds pressure on sites without enhancing the study outcomes.

Kenneth Getz, Executive Director of Tufts CSDD and lead author of the manuscript, noted that clinical trial sponsors are facing mounting demands for increased data collection. The study’s findings serve as a vital tool in transforming outdated protocols, making clinical trial processes more effective and efficient for future studies.

Addressing the Complexity

One of the key insights from the study is related to the increased complexity that comes from non-core data collection. These are procedures not directly contributing to the trial's main objectives, and they can represent up to 32.5% of the data collected per patient in Phase III trials. Furthermore, 25-30% of the burden placed on trial participants and investigative sites arises from this non-essential data collection. In non-oncology trials, this inefficiency may even rise to 40%.

This calls into question whether all data is necessary at all stages of research. Interestingly, while 77% of non-core data finds its way into Clinical Study Reports, much of it remains exploratory and not actively analyzed, further justifying the need for a reevaluation of early-stage data collection practices.

Laura Galuchie, Senior Director at TransCelerate and Merck’s Program Lead, emphasized the importance of this study. It invites critical reflection on how data is collected and why, ultimately pushing for a more intentional approach. As Galuchie stated, “Smarter data strategies aren't just better science—they're essential for more efficient, equitable, and patient-friendly research.”

The Road Ahead

TransCelerate's Optimizing Data Collection team has already begun the task of developing tools and frameworks to assist research and development organizations in maximizing the utility of the data they gather. The aim is to refine data collection processes, ensuring each data point aligns with scientific, regulatory, or patient-centric objectives without overwhelming trial participants.

This collaborative study, which has now been submitted for publication, serves as a beacon for inviting future dialogue around restructuring clinical trial protocol designs. As the healthcare landscape evolves, studies like this reinforce the importance of adapting strategies to improve the clinical trial ecosystem, ultimately benefiting the researchers, the sites, the sponsors, and most importantly, the patients involved.

Keynote Presentation

The findings from this study will also be presented in a keynote speech titled "New Insights on Optimizing the Collection of Protocol Data" at the DPHARM Disruptive Innovations to Advance Clinical Trials Conference on September 17, 2025. This event offers further opportunities to explore the insights gathered from this significant study and their implications for future clinical research practices.

Conclusion

In conclusion, TransCelerate and Tufts CSDD's study highlights essential opportunities to optimize clinical trial design through strategic data collection. By prioritizing patient experience and operational efficiency, the study sets the groundwork for a new era of clinical research that is both more effective and more considerate toward those who participate in it.