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 Highlights
The takeaways, both expected and surprising, from 2020 protocol performance data
The factors that are contributing to increased complexity in clinical trial protocols
Why simplifying the design of a study is not the right goal
The inherent benefits in complexity, and how we can reap them through proper management
What drives regulatory agencies to seek to quell rising complexity in clinical trial protocols
Why more data isn’t necessarily better
The importance of investigating underlying causes of problems rather than defaulting to solving them with volume
What happened to feasibility committees and what should replace them
Why it’s critical to incorporate patient input into study design
The consistent positive impact of patient advisory boards
How taking the time for thoughtful advanced planning can help preclude costly unplanned amendments later on
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