Conversations in Clinical Trial Readiness: Ken Getz - Tufts Center for the Study of Drug Development

Описание: https://www.archemedx.com/
Ken Getz joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss protocol complexity in clinical trials. The Director of the Tufts Center for the Study of Drug Development and a Research Professor at the Tufts University School of Medicine, Ken shares his insights on protocol design along with strategic advice on how to design for maximum impact.

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
• 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
• 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

Links
https://csdd.tufts.edu
  / ken-getz-9a53b811  
http://www.ciscrp.org
https://www.centerwatch.com

Quotes
• “Protocol complexity is inversely correlated with performance. The more complex a protocol becomes, the worse the performance by every measure.”
• “Complexity is a reality, and it has a lot of benefits. We just have to manage it more effectively.
• “The biggest expert of all is the person living with the burden of disease.”
• “There’s so much that sites can teach sponsors about the challenges that they face in executing the designs of these studies.”
• “Often people talk about the amendment as the problem. The amendment is the solution to an underlying problem.”
• “This is such an exciting time given many of the new approaches that are being brought to the clinical research community, especially during the pandemic.”