In this compelling episode of "In the Interim," Dr. Mike Krams, a seasoned expert in clinical trials and drug development, joins us to discuss the art and slog of innovation in pharmaceutical companies. With over 30 years in the field, Dr. Krams shares insights on leveraging Bayesian statistics and innovative designs to transform development approaches. The conversation explores disruptive approaches to drug development, the importance of having champions for change, and the future of innovation in clinical trials. Mike highlights the necessity of integrating strategic decision-making with statistical expertise to enhance the efficiency and effectiveness of clinical trials.

Key Highlights:

• Discussion on the ASTIN Stroke Trial, a groundbreaking experience with Bayesian methodology in drug trials.
• Examination of how adaptive designs can lead to more efficient learning processes in clinical research.
• Exploration of the cultural and strategic challenges of bringing innovative trial designs to conservative pharmaceutical environments.
• Insight into the vital role of having internal champions to advocate for change and innovation.
• The importance of integrating strategic thinking with statistical expertise to drive innovation forward.

Quotes:

• "Respect is earned, but very good communication skills are a necessary condition for implementing innovation." – Mike Krams
• "Innovation for innovation's sake is not the goal; it's about making better decisions for future patients." – Mike Krams