Insights

The U.S. Food and Drug Administration’s (FDA’s) recent launch of an agency-wide large language model–powered artificial intelligence (AI) tool known Elsa and ongoing efforts to have another AI tool known as CDRH-GPT in place for speeding up reviews and approvals of medical devices by the end of June have attracted their share of both supporters and detractors. With AI seemingly also coming at full speed into the daily routines of leaders and staff at clinical trial sites, contributors to ACRP’s Clinical Researcher journal are taking a closer look at current and potential applications of AI by study teams at work in the trenches. 

In the midst of this Pride Month, current politically motivated headwinds may be driving some of the terminology related to inclusive research underground, but the scientific rationale for inclusive studies is here to stay because “smart science is smart business,” says a presenter from ACRP 2025.