WEBCAST | Product Development

First digital endpoints to land on drug labels this year, DiME CEO predicts

Digital Medicine Society CEO Goldsack said approvals based on digital endpoints are on the way

April 6, 2023 12:17 PM UTC

The use of digital endpoints in clinical trials is expanding rapidly, and they will soon be included on drug labels, Jennifer Goldsack, CEO of the Digital Medicine Society, predicted.

“I would be shocked if we didn’t have a label this year” with a digital endpoint, Goldsack said in an interview with The BioCentury Show. She added that an approval this year based on a digital endpoint is possible.

DiMe started tracking the use of digital measures in clinical trials of medical products three and a half years ago. “Back in October 2019, we were delighted to report that there were 34 digital endpoints that were being used by 12 sponsor companies, and we thought that this was tremendous,” Goldsack said. “Fast-forward to where we are today: there are 374 digital endpoints being used by 107 sponsor organizations currently to answer questions about the safety and efficacy of new medical products.”

Most digital endpoints will be approved as part of product applications rather than through independent qualification pathways, she said.

The challenge and opportunity, according to Goldsack, is to use these new tools to redefine disease, rather than to replicate the often imprecise and unreliable metrics that are currently used in clinical medicine. “If all we do with these new digital tools is replicate exactly what we’ve always done using different modalities, while there might be incremental benefit of being able to overcome the challenges of place, for example, we leave all of the other benefit on the table.”

In a wide-ranging conversation, Goldsack discussed DiMe’s development of open-access digital tools for helping medical product developers enhance the diversity, equity and inclusion parameters of their work, as well as the society’s training programs that aim to help biopharma companies develop digital literacy and promote an understanding of the ethical dimensions of digital medicine.

Goldsack also assessed the rapid adoption of generative artificial intelligence tools such as ChatGPT. She noted the broad enthusiasm for interacting with generative AI and the possibility of using it for tasks ranging from improving “medical records to patient education and clinical decision support.” At the same time, she said, “we have to make sure that we are using them to solve pressing challenges in the field.”

Acknowledging the risks associated with generative AI, Goldsack said, “we have to figure out a way of evaluating the performance of these new tools, and I think it probably will come down to, if not regulation, then some independent third party that actually does the work of certifying these new tools and products in order to keep people safe and in order to make sure that when we do decide to use these tools, we are able to derive value from them, and we aren’t taking on new and additional risks.”