Powerful forces of change are transforming the clinical trials landscape—and that’s a good thing, says Ken Getz, director of sponsored research and associate professor at the Tufts Center for the Study of Drug Development and founder of CenterWatch.
“It’s exciting but also daunting, because it forces us to confront and consider” structural and operating changes that will impact the industry for generations to come, including the latest wave of consolidation driven by contract research organizations, institutional review boards, and investigative sites, he notes.
Getz lauds this “paradigm shift” in part because it will advance the use of e-data, remote and risk-based monitoring, and other analytical tools.
Clinical research associates (CRAs) must be prepared to meet new performance expectations, Getz says. In addition to embracing new technologies and new ways to collect clinical trial data, CRAs will need to learn how to function effectively in larger site networks and health systems, where more physicians and data are drawn from satellite offices and remote locations.
“Trends and changes are unfolding that will profoundly impact how our enterprise manages its innovations and how it will operate and perform,” he says.
Getz will discuss these major changes in April at the ACRP 2016 Meeting & Expo in Atlanta, Ga., including:
- growth of precision medicine;
- the consolidation of research sponsors and service providers;
- the convergence of clinical research and clinical practice;
- the use of wearable and mobile devices and new technology solutions; and
- more sophisticated uses of large and growing structured and unstructured data and information for scientific and management purposes.
The overarching consolidation could improve operating performance through efficiencies of scale; broader adoption; and more systematic and consistent execution. “As sectors across the drug development landscape achieve new levels of operating scale, the breadth and depth of healthcare and clinical data and powerful analytical tools will drive major improvements in detecting safety and efficacy signals, risk-based management approaches, and predictive recruitment and retention,” Getz says.
Learn more about Getz’s presentation, An Aerial View of Forces Reshaping the Global Clinical Research Enterprise.