Thinking Outside The Box: A New Approach To Managing Adaptive Trials

A large contract research organization, with funding from the National Institutes of Health, needed to find a simpler way to handle changes in clinical-trial protocols once its clinical trials were under way. Although the organization is a leading research institute that routinely conducts numerous clinical trials in the United States and around the world, its researchers and trial site personnel were manually performing many tasks, such as using paper forms and spreadsheets in the clinics to schedule and record visits and to track each trial participant’s progress. These manual approaches severely limited the number of studies and participants the organization could manage at any given time. 

In an effort to address their needs, researchers at the organization conducted a survey of the available clinical trial management systems (CTMS) and came to the conclusion that there was no existing CTMS package that would support three essential needs:

• visit scheduling, with complex visit-window dependencies;
• protocol decision points to route participants from one arm to another, based on clinical data collected at a previous visit; and
• rapid protocol amendments.

After their exhaustive search proved unsuccessful, the researchers resigned themselves to using custom code, despite the high cost. That’s when they asked OTB Solutions Group to assist them by defining requirements and designing a custom visit-scheduling solution.