The Evolving Data-Driven Strategic Feasibility Model
How democratization of data is powering a new wave of opportunities
Key Challenges
Today’s clinical research environment is more competitively challenging, has higher costs and takes longer to bring a drug to market than at any other time in history. According to the 2015 Tufts Center for the Study of Drug Development research, from 2005-2015 the average Phase III study saw an increase in the complexity of protocols, driven by the ever-increasing set of inclusion and exclusion criteria (+61%), number of clinical endpoints (+25%), and number of study visits (+25%) and procedures (+70%), are driving more and more protocol amendments and adding to that cost and time. At the same time, the percentage of patients taking part in clinical studies remains at historically low rates, estimated to be less than five percent of the patient population. This contributes to low and non-enrolling sites, further contributing to the cost and time.
One of the common threads across all these challenges, is that data exists that could help address the underlying needs, but that data is often siloed across people, teams and companies, preventing it from helping to drive the right insights at the right time. By breaking down barriers and democratizing data, we are moving towards a future where that data and powerful analytics will come together to help design and execute clinical trials, bending the time cost curve of drug development...
