Keynote: Simplified Trials, Community Engagement Key to Reinvention of Clinical Research

Robert A. Harrington

In his keynote presentation at TCT 2015, Robert A. Harrington, MD, of Stanford University, in Stanford, Calif., addressed the need to redefine clinical research in the era of big data. 

Simplifying large trials, engaging participants via social media and investing in the next generation of clinical researchers are key tenets of this redefinition, Harrington asserted, adding that use of information technology to achieve those goals will provide high-quality data to guide practice and inform future research.

 “Less than a quarter of … our class I recommendations are supported by high-level evidence, or grade of evidence A,” Harrington said. “We can do better in [generating data about] the disease that is the most common disease across the globe.”

Simplifying trials, data collection 

Current research has strayed from the original large, simple trial paradigm, Harrington said.

“Like so many other U.S. industries, clinical research has become so expensive and inefficient, that it may no longer be a viable, competitive enterprise within our borders,” he observed. “We have to change this.”

Baseline Study – a large epidemiological collaboration developed through Duke University, Stanford Medicine and Google – is an example of a simplified trial that seeks to establish a basic understanding of human health and transition to diseases, including cancer and cardiovascular disease. Data will be collected through both innovative and conventional technologies.

“We anticipate that with every patient, at every visit, we will generate four terabytes worth of data over the course of the study,” Harrington said. “Clearly, this is an era with big data that is only made possible with information technology.”

As large clinical trials became popular, they increasingly grew in complexity, according to Harrington. In order to return to a simplified design, the research community needs to incorporate randomized questions into the collection of everyday data.

Cellphone applications – such as the Stanford-led “MyHeart Counts” project – can generate global cardiovascular data directly from patients. Information derived from app users on their physical activity, general well-being, and their sleeping and dietary habits, can be used to conduct randomized experiments provided informed consent has been obtained. 

Using the application, “we now have 6-minute walk data on more than 6,000 individuals, redefining all the previous observations that have been made about [those] standards,” Harrington said.

The training imperative  

Given the influx of all these new data, future physicians will need updated skills to incorporate innovations into their everyday practice.

“We need a new method of knowledge for our trainees; this is a different era than [when] we all entered [the medical field],” Harrington said. “They need new skills and informatics … to be able to practice utilizing large and vast amounts of information.”

Innovators also should have a place in academia, he added.

“We need our innovators to see that universities can … work in concert with our commercial colleagues and our government colleagues to move new ideas to the marketplace,” Harrington concluded.


  • Harrington reports relationships with multiple device and pharmaceutical companies.