Balancing Innovation and Compliance under New GCP Guidelines

In a recent video interview with Applied Clinical Trials, Heidi Chen, Associate Director of Research & Commercial Services at Citeline, discussed findings from the company’s 2025 Annual Clinical Trials Roundup. She outlined how personalized and biomarker-based therapies are creating opportunities and challenges for trial design, especially in rare disease populations, and highlighted the use of historical controls and real-world evidence to support targeted development. She also explained the growth in CNS, autoimmune, and obesity trials, noting the operational implications for study design, site selection, and adoption of decentralized and hybrid trial models. Finally, she discussed how sponsors and CROs are navigating new ICH GCP guidelines while continuing to innovate and maintain data integrity, emphasizing resilience and the ongoing expansion of the clinical pipeline.

The below interview transcript was lightly edited for clarity.

ACT: As new ICH GCP guidelines roll out, how are sponsors balancing the drive for innovation—especially in areas like CAR-T and GLP-1s—with rising expectations around compliance and data quality?

Chen: Yeah, that is definitely a hot topic right now. We do expect that these guidelines will increase responsibilities on both sponsors and CROs. For CROs, it’s because they're running and managing the trials. For sponsors, they will have to align new requirements into their development process to ensure compliance. Ultimately, the goal of these guidelines is to streamline clinical trials so that patients are more protected and data integrity is upheld.

We also need to keep in mind that the rollout of these guidelines has been staggered across different countries. For example, in the US, the FDA rolled out the new guidelines in September [last month]. How sponsors balance trial innovation with these new responsibilities is a developing situation, and it’s hard to predict reactions. For global trials, where ICH GCP rollout may occur on different schedules from site to site, that represents a logistical challenge and responsibility sponsors must carry.

Overall, we expect innovation to continue thriving rather than slowing down because the need to get therapies to patients faster remains a top priority. The clinical pipeline continues to grow each year, despite headwinds the industry has faced, such as the pandemic disruption, which was unprecedented. New technologies, like AI and other digital advancements during that time, helped the pharma industry navigate this disruptive era. We expect the industry to remain resilient.