Simplifying Clinical Trials: Less Data Could Mean Better Results

In the world of drug development, collecting data is crucial. However, a recent study suggests that too much data can actually slow down clinical trials. The study, conducted by Tufts Center for the Study of Drug Development, Tufts University School of Medicine, and TranCelerate Biopharma, found that nearly one-third of the information collected in trials is non-essential. This extra data often comes from patient surveys, adding unnecessary burden to participants and trial sites. Kenneth Getz, the study’s lead author, emphasizes the importance of thoughtful protocol design to ease this burden and improve patient participation. Over the years, clinical trials have become more complex, with advanced therapies and global trial sites. This complexity leads to more protocol deviations, amendments, and slower enrollment. A recent Nature study confirms this trend, showing that increased trial complexity leads to longer trial lengths. While some challenges are unavoidable, many are self-inflicted as companies push for more data points. Getz notes that companies often add unnecessary questions to patient questionnaires, increasing the burden on participants. Many trials also collect lower-priority information or data that will only be useful later. Non-core procedures, which don’t support primary or secondary endpoints, account for up to 32.5% of phase 3 data collected per person. These procedures also contribute to the burden on trial participants and research sites. As protocols become more complex, problems multiply, leading to higher dropout rates and slower enrollment. The study aims to encourage protocol designers to be more thoughtful about what data to collect. Getz hopes the study sparks a discussion among protocol authors and clinical teams. TransCelerate’s member companies are using study insights to develop a framework and toolkit, which could be rolled out in early 2026. Ultimately, the goal is to optimize protocol design to avoid hindering the drug development process.