TransCelerate Research on Improving Clinical Trial Data Collection Published in DIA's Therapeutic Innovation & Regulatory Science

New research opens the door for more streamlined and patient-centric protocols, informed by benchmarking analysis of phase II and III protocol procedures

PHILADELPHIA, Jan. 6, 2026 /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 peer-reviewed publication of its collaborative study with the Tufts Center for the Study of Drug Development (Tufts CSDD), Tufts University School of Medicine in Therapeutic Innovation & Regulatory Science (DIA TIRS). The publication marks the latest milestone in an effort to help the biopharmaceutical industry better understand and address the growing complexity of clinical trial data collection.

The research assesses how protocol design practices have evolved and identifies areas where sponsors may be able to reduce scientific and operational complexity while lowering participant and site burden. The newly published final manuscript, "Insights Informing Strategies for Optimizing the Collection of Clinical Trial Data," represents the peer-reviewed, final publication of the analysis previously shared as a pre-print.

"The preprint version of the manuscript and recent conference presentations have generated very strong positive responses to the results and insights from this collaborative research study," said Kenneth Getz, Executive Director, Tufts CSDD, and lead author. "We're delighted that the final published manuscript is now available and hope that the benchmarks and insights from the study will reach an even larger audience."

The published manuscript underscores several clear patterns: despite rapid growth in data volume – Phase III protocols now average 5.96 million data points – almost one-third of study procedures do not support primary, key secondary and safety endpoints or were conducted more times than necessary. These non-core and non-essential procedures contribute substantially to participant and site burden and add operational complexity without advancing the study's main objectives and outcomes. The peer-reviewed manuscript outlines where inefficiencies originate and offers practical considerations for sponsors as they modernize protocol design in alignment with ICH E6(R3) guidelines, which encourage fit-for-purpose data collection to reduce unnecessary complexity and burden while maintaining trial quality.

TransCelerate's Optimizing Data Collection team is advancing tools and frameworks to help R&D organizations assess the scientific, regulatory, and operational utility of the data they collect. The goal isn't to eliminate entire categories of data collection, but to ensure every data point meaningfully advances scientific, regulatory, or patient-centered objectives. These resources are designed to help sponsors assess not just how much data is collected, but why it is collected, ensuring that each data element contributes effectively to scientific, regulatory, or patient-centric goals. Looking ahead, we plan to collaborate with patient groups, sites, and other stakeholders to further refine and develop these tools, ensuring they reflect diverse perspectives and real-world needs.

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 nearly 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.

SOURCE TransCelerate BioPharma