Data-Driven Approaches Gaining Favor With Study Sponsors

June 28, 2019 | A succession of global clinical development executives and strategic planners at this year's SCOPE Summit spoke about the radical shift away from traditional feasibility questionnaires and opinions of people on the ground to select sites for trials. Many of them were happy to continue the conversation with me in the weeks that followed to dig deeper on the datasets, methodologies, and collaborations that will be informing their approaches moving forward.

The result was this comprehensive series on "Right-Sizing Site Selection," which I've broken into four parts. The first frames the problem being addressed—perennial poor enrollment statistics and the contributing role of study protocols, despite reams of historic performance data and ways of surfacing investigators and making better enrollment predictions. The second installment homes in on Janssen's innovative data science approach, which gets at the key drivers of enrollment success and ways to improve racial diversity in trials—in addition to uncovering potential issues with some of the datasets currently being utilized.

In part three of the series, a trio of other study sponsors discuss the different ways they're using data to select sites and investigators. While Pfizer is attempting to "hardwire" a reliable, holistic approach to evaluating sites, Allergan is doing more with less by both mining databases and leveraging the know-how of site monitors. Under Merck's model, sites themselves have a lot to say in the selection process. And IQVIA reports that it is producing metrics on its AI-powered profiling technique.

In the final installment of the series, you'll meet Merlin, the data-driven feasibility and site identification platform newly created by AstraZeneca that will be ingesting real-world data and doing some predictive modelling. The Association of Clinical Research Professional's Jim Kremidas will also be making his compelling pitch for "professionalizing" sites through a formal and evolving certification process. He also points hopefully to an emerging trend whereby research is being integrated into clinical practices, introducing more people to trials as a care option.

I hope the insights they've shared prove useful to other sponsor companies looking for their best-fit approach and sites hoping to be their trusted partners in getting needed medicines to market without undue delay.

—Deborah Borfitz, Senior Science Writer, Clinical Research News