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What is Keeping us from Data Driven Decision Making?


This past Thursday PhUSE held a single day event in Canada to explore solutions around the ability to understand and analyze real time data to make decisions more quickly.  The event took place in Mississauga, Canada as PhUSE continue to grow globally as the industry leading organization for sharing and innovating in the clinical data space. 

The topic of data-driven decision making is a great buzz phrase which generates a lot of energy, and we have seen an increase on presentations around machine learning, AI, advanced computational power which gives us promise that we can make a giant leap forward in getting real value out of our data. 

So why haven’t we gone viral with these technologies and transformed the data analysis process?

I believe there are two key roadblocks to fully embracing and leveraging the technologies that so many other industries are using. The first roadblock is the regulatory shackles we put on our industry – some of which are real and some of which are self-imposed. We are afraid to try new things for fear that it will either slow down our internal operations or the FDA won’t accept our submission using these new-fangled ideas. We continue to grind through the same processes and tools we have used for 40 years making no progress towards really getting value from our data.  We must engage regulatory agencies in this process and work together to change our approach to the regulatory requirements and change the mindset of both sides of this equation before we will truly see the value of data driven decisions.

The second roadblock, and in my opinion, the most critical is the fundamental need to change the way, we collect and store our clinical data.  Since the beginning of digital data, we have collected data in two-dimensional data sets and stored information about that data separately and by doing this we completely lose the context and meaning of the data. Other industries model and store data in a vastly different approach integrating the content and context so decision making can be truly data driven.

When we tackle these roadblocks head on, we will truly realize the massive benefits of letting the data drive our decisions.  The healthcare industry is determined to accelerate access of promising treatment for patient health. Innovative and adaptive clinical trial designs, along with the use of Real-world Evidence (RWE), is becoming much more prominent. This PhUSE event will explore potential solutions to understanding and analyzing dynamic data real-time, with the use of statistical methodology, tools and automation, to allow for quicker data-driven decisions for clinicians and agencies.

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