18 Aug How To Design A Clinical Trial Protocol With Patient And FDA Collaboration

By Clinical Leader Editorial Staff, Clinical Leader

In a recent Clinical Leader Live! episode hosted by Life Science Leader Chief Editor Ben Comer, clinical trial experts Mitchell Katz, SVP, global clinical operations at Kyowa Kirin; Jessica Powell, VP, clinical operations at Alto Neuroscience; and Michael Krams, chief quantitative medicine officer at Exscientia, sat down with Comer to discuss current best practices for designing clinical trials that secure FDA approval and provide significant benefit to the patient. The wide-ranging discussion produced several key takeaways, including direct insights into how these seasoned drug developers have approached protocol design, collaboration with patient advocacy groups, and FDA relationship-building.

Determine What To Include (And What To Leave Out) Of Your Phase 2 Clinical Trial

Designing a protocol requires thoughtful consideration of what should be included and what can be left out. To help you navigate this process, the expert panel recommends building a strong relationship with regulators and collaborating with other sponsors to gain insight into what components are critical to include and what might be overkill.

According to Katz, “The beauty of drug development is the fact that it gives us an opportunity to share with colleagues across the industry and… look at the competitive landscape to see what other organizations are doing. If we have a good relationship with regulators, we have a good sense of what we want to do as far as our regulatory and clinical strategy. They guide you and make recommendations as to what [at a minimum] you should put into a protocol to help you ask the questions you want [to answer] as an organization.” Read more…