Ken Getz is the Director of the Tufts Center for the Study of Drug Development and a Research Professor at the Tufts University School of Medicine. Ken is an expert in drug development management and practices who has dedicated much of his career to raising awareness of clinical research enterprise.In addition to frequently speaking at industry events and publishing in peer-reviewed journals, Ken is the founder of several organizations, including the non-profit CISCRP and the publisher CenterWatch. His career is a true testament to his belief in the importance of transparency and keeping all clinical research stakeholders well-informed.Episode HighlightsThe takeaways, both expected and surprising, from 2020 protocol performance dataThe factors that are contributing to increased complexity in clinical trial protocolsWhy simplifying the design of a study is not the right goalThe inherent benefits in complexity, and how we can reap them through proper managementWhat drives regulatory agencies to seek to quell rising complexity in clinical trial protocolsWhy more data isn’t necessarily betterThe importance of investigating underlying causes of problems rather than defaulting to solving them with volumeWhat happened to feasibility committees and what should replace themWhy it’s critical to incorporate patient input into study designThe consistent positive impact of patient advisory boardsHow taking the time for thoughtful advanced planning can help preclude costly unplanned amendments later onResources:Tufts Center for the Study of Drug DevelopmentKen Getz on LinkedInCISCRPCenterWatchConversations in Clinical Trial Readiness Interview Series