TransCelerate BioPharma (TransCelerate), a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying clinical research, has officially published the results from a new collaborative study, conducted in close collaboration with the Tufts Center for the Study of Drug Development (Tufts CSDD), Tufts University School of Medicine.
Going by the available details, this survey treads up a long distance to reveal significant opportunities to reduce participant and site burden across clinical trials through smarter, more efficient data collection.
More on that would reveal how the given study was markedly structured to analyze the volume, purpose, and impact of data collected in clinical trials, particularly focused on data coming out of non-core and non-essential procedures. Not just that, it also made a point to identify opportunities for optimizing protocol design.
To achieve its objectives, the whole exercise derived data from 105 Phase II and III protocols across 14 biopharmaceutical companies, eventually finding that nearly one-third of procedures and the associated data doesn’t directly support primary objectives or key secondary endpoints. This translates to overall data volume continues to climbN Phase III protocols, now averaging 5.96 million data points.
“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.”
Markedly enough, TransCelerate’s new study markedly resets the benchmark when it comes to incidence of non-core procedures, including those not directly supporting primary or key secondary endpoints. This it does while simultaneously introducing a new baseline measure on the incidence of non-essential procedures i.e. those performed more often than scientifically necessary.
Once you package them all together, though, the said types of procedures account for up to 32.5% of Phase III data collected per patient, along with 25–30% of total burden on trial participants and investigative sites. Not just that, the resulting combination also accounts for significant inefficiencies throughout non-oncology trials, where up to 40% of patient-level data falls into these categories.
Among other things, it ought to be acknowledged that clinical trial datasets were found to contain large volumes of lower-priority data, and therefore, birth unnecessary complexity for sites and participants. We get to say so because 77% of non-core data appears in Clinical Study Reports (CSRs), with much of it being exploratory or intended for future use and not actively analyzed.Â
“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.”
