TL04: Adaptive Design Execution: Being GCP Compliant
*Philip T Lavin, Aptiv Solutions (formerly Averion Intl Corp) 


Philip Lavin and Judith Quinlan, Aptiv Solutions

In 2010, the FDA released their draft guidance on adaptive designs. While the guidance was obviously the result of hard work by many within the agency, it was also seen by many in industry as reward for those who had worked hard over the past decade to promote the “responsible” use of the methodology. However the guidance does not mark the end of a journey, but signifies the beginning where industry shoulders the responsibility for execution according to Good Clinical Practice which encompasses maintaining trial integrity and controlling operational bias.

This session will discuss managing the more complex logistics associated with adaptive design execution. We will lead a discussion of the process for planning and executing an adaptive trial. The discussion will cover logistical considerations with a particular focus on the issue of controls including firewalls and identifying where and how information leakage could occur, along with suggestions for possible solutions. Examples of what could possibly go wrong will also be used during the session for illustration purposes.