Real-Time Data. Real-Time Decisions. Real-Time Difference.

It’s 2020, and the digital revolution is well on its way. Yet, for clinical trials worldwide, real-time access to data is not the norm—and that lack can create a cascading set of issues affecting every aspect of a study. With critical decisions too often being made in a digital data vacuum, at best, processes are not as efficient as they could be; at worst, serious problems may go undetected for weeks or even months.

As the amount and types of data expand exponentially, this problem only intensifies. Yet, ironically, that very growth in data sources may be one reason solutions have been slow to take hold. In a recent analysis, the Tufts Center for the Study for Drug Development reported that more than twothirds of all sponsors are using at least four different data sources. They find the tasks related to rendering that data usable—importing and ingesting data, transforming and mapping data, cleaning, and reviewing data—to be extremely time-consuming. That slows use. Worse, they also find initiating relationships with data vendors to be extremely time-consuming, so iterating to new technological solutions can feel daunting.

What does this mean for clinical trials? Pharma Intelligence decided to find out, surveying professionals involved in clinical data management. Their pool of respondents comes from large pharma companies, biotech companies, device developers, and contract research organizations worldwide. Their findings, published in Challenges and Opportunities in Clinical Data Management, Research Report September 2018, underscore the severity of the problem.