Over the past decade, the process of developing and bringing to market new drugs and medical devices in the U.S. has dramatically increased in complexity, duration, and cost which poses significant new challenges for the healthcare system and the patients it serves. Increasingly complex regulatory filters, asymmetrically distributed research structures that hinders collaboration, and the sheer scale and complexity of the clinical trial processes has induced a large burden on governments, institutions and markets such that significant consequences occur at both national and global levels.
The collaborative and multi-disciplinary approach of the CTSP insures that the complexity of a system such as the clinical trial processes is addressed as a whole, rather than focusing on its specific parts. To maintain objectivity, the project explores solutions using broad system boundaries in a way that behaviors observed within the system can be logically interpreted as the boundaries expand.
Our core team integrates strategic, design and systems capabilities. As the project advances and our knowledge about the clinical trials process increases, the balance between our strategic, systemic and design goals generates the triggers for change: the true (what we know); the real (what we can measure); and the ideal (what we aspire to). This project began on November 1st, 2014.
This project will utilize systems thinking and design principles to identify and map the current clinical trial process, identify breakdowns in the process and develop strategies to address those breakdowns. By taking a broad view of the system our goal is to identify areas that have not been addressed which will have a major impact on the system as a whole.
We recognize that there are many groups looking deeply into the individual pieces of the clinical trial process and we plan to work with them as we take this broader perspective. The intent of the project is not to compete with but to augment current work being done.
The project will use the tools that engineers and architects are trained in, to visualize the current system, a potential future state and pathways to get there. A critical component of this strategy is that we do not enter the project with a hypothesis to test. We model the current state and work back to identify critical breakdowns, then move forward to address those breakdowns.
Click here to access the online tool for interacting with available clinical trials data.