21-June-2022

Among many advances in drug development and healthcare that were proceeding slowly only to be significantly boosted to overcome the novel challenges caused by the COVID-19 pandemic is the use of real-world data (RWD) and artificial intelligence (AI) solutions in clinical development. In this extended Q&A, Jeff Elton, Ph.D., Chief Executive Officer of ConcertAI, and Pharma’s Almanac Editor in Chief David Alvaro, Ph.D., discuss the promise and the rapid evolution of this disruptive technology, data sources, ethical considerations, and the role ConcertAI is taking as an accelerator of evidence generation.

David Alvaro (DA): How would you characterize historic attitudes toward the use of RWD in clinical trials, and how have things evolved over the last couple of years?

Jeff Elton (JE): The last couple of years have definitely been transformational for this space. If we looked way back at the earliest intersections between RWD and clinical trials, we would find some RWD that was used in consultative conversations with the U.S. FDA to illustrate the standard of care or to explain the study design in light of that standard and the lack of response in the population. In certain cases, for a particularly rare, devastating disease, the FDA had allowed for an external control arm that used retrospective data instead of a standard-of-care control, because it’s not ethical to put vulnerable patients on a standard of care that is known to have little if any benefit….

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