The Patient Equation

11Changing Clinical Trials

The way we run clinical trials hasn't changed significantly in decades. Yes, we're doing things online instead of on paper, and, yes, most organizations are starting to be open to new types of measurements, in the home instead of in the clinic, with wearables and other new-generation devices, and, sure, there is a growing sense that we can enhance the data set with new approaches and ideas.

But it is still early days, and trials are still on the fringes of the data revolution—for now, partly because of the huge expense involved in launching a trial—and thus the fear of taking an expensive risk on the unknown—and partly because there hasn't been much reason or industry impetus to move trial design, trial collection, or trial access forward. That has to change. It's that simple.

To reach the full potential that these new patient equations offer, clinical trials need to evolve. And they need to evolve in three ways. We need to change the way patients find and participate in trials (what people call “access”), we need to become comfortable collecting new kinds of data in new ways (going all the way in terms of scale from DNA to behavior and our environment), and we need to move to new mathematical designs. We need to innovate with new trial frameworks and techniques that will help us more effectively discover the inputs and outputs of the equations that will lead to maximum benefit for patients. In this chapter, we cover all of these issues in depth. ...