Streamlining Trial Design to Accelerate Data Delivery and Investor Confidence

In a recent video interview with Applied Clinical Trials, Ben Edwards, chief operating officer, Avance Clinical, discussed common challenges in biotech, emphasizing the importance of addressing preclinical package gaps to avoid delays. He highlighted the need for CROs with deep scientific capabilities to create a sound scientific argument for new drugs. In the current funding climate, he stressed the importance of obtaining patient data early to inform decision-making. Edwards also noted the shift towards adaptive trial designs and the benefits of staying with the same CRO for continuity. Effective coordination across functions requires integrated teams and data visualization. Parallel execution strategies, combined with rigorous protocol design and early regulatory engagement, can accelerate development while maintaining compliance.

ACT: With the current funding climate favoring late-stage assets, how are clinical operations teams adjusting their processes to avoid delays that could impact investor confidence?

Edwards: In today's world, especially, we see with emerging biotech, data is key. They really need to get data in their hands as soon as possible, and that's just not healthy volunteer data, but it is definitely data from actual patients in the indication that they're looking to treat. Most of our clients these days, as they're entering the clinic, they're thinking about ways to not only get that single ascending, multiple ascending dose safety information, but can they add a patient cohort onto the back end of that study? Is there a way that they can get that early signal of data quickly and get it in their hands? It's all about intelligent trial design, and not only that. Once they have the trial design locked down, making sure that the protocol and the study considerations is collecting that only the data that they're really looking for and they really need, so streamline data design, and then the third element of that is ensuring that the data is being cleaned efficiently, analyzed efficiently, and that they really get the data in their hands quickly. So yes, there might be a full package that they receive at the end of the study, but are there particular tables, listings, and figures or data sets that they need that they can get in their hands quickly to inform their next decision making? Those are the three key elements, really.