In today’s fast-paced pharmaceutical industry, the need for data in clinical trials is ever-growing. However, a recent study conducted by Tufts Center for the Study of Drug Development, Tufts University School of Medicine, and TranCelerate Biopharma has shed light on the potential drawbacks of collecting excessive data in phase 3 trials.
The study, which analyzed 105 trials, revealed that nearly one-third of the data collected was deemed “non-core” or “non-essential.” Surprisingly, more than half of this extra data came from patient surveys, indicating a potential area for streamlining protocols.
Kenneth Getz, the executive director of Tufts CSDD and lead author of the study, emphasized the importance of simplifying protocols to reduce site and patient burden. With the increasing complexity of clinical trials due to advanced therapies and global trial sites, it’s crucial to rethink data collection strategies.
A Nature study also highlighted the trend of increasing trial complexity over the last decade, leading to longer trial timelines. While some challenges are unavoidable, self-inflicted factors such as adding unnecessary data points can further slow down trials.
Companies often fall into the trap of gathering excessive biomarker information or non-core data that may not be immediately relevant. This not only burdens patients and research sites but also contributes to protocol deviations and dropout rates.
To address these issues, the study aims to spark a discussion among protocol authors and clinical teams to optimize protocol design. By prioritizing essential data collection and reducing unnecessary procedures, trials can become more efficient and patient-friendly.
TransCelerate’s member companies are already using the study insights to develop a framework and toolkit for protocol optimization, expected to be rolled out by early 2026. It is essential to get protocol designs right to streamline the drug development process and improve overall trial outcomes.
In conclusion, while data is crucial for advancing medical research, it’s equally important to strike a balance and avoid overwhelming protocols with unnecessary information. By reevaluating data collection practices and focusing on essential endpoints, the industry can enhance the efficiency and effectiveness of clinical trials.
