Expect stakeholders to increasingly generate and utilize real-world data (RWD) on patient experiences and quality of life (QoL) this coming year as industry continues to move toward forging parallels to the traditional randomized trial, says Lowell Zeta, partner, global regulatory, FDA & Life Sciences at Hogan Lovells.

Zeta, former senior counselor to the FDA commissioner, predicts that industry will increasingly focus on data that provides insights and perspective on patient experiences and QoL in 2024. While the traditional randomized trial isn’t going anywhere, sponsors are looking to leverage alternative sources of information to inform their drug development programs.

“From an industry trend [perspective], what we’re hearing from companies is that it’s already expensive, time-consuming and challenging to go through the traditional randomized clinical trial route,” Zeta said during a webinar last week presented by FDAnews, a WCG company. “Where we have seen some really interesting discussion and progress is the potential impact of generating, as RWD, the patient experience and QoL data to even inform new novel endpoints and improve outcomes.”

Industry could, for example, measure the patient experience for a central nervous system or addiction treatment in addition to measuring the primary endpoint of overcoming an addiction. “The arc to get there can be really challenging if we think clinical symptoms — migraines, sweating, you can’t eat. Tracking some of that could help inform drug development decisions,” he said.

At the same time, while generating real-world evidence in parallel and employing such innovative approaches as using digital health technologies to gather data remotely can help speed drug development, Zeta said some stakeholders are still struggling to determine the best strategies in this area.