A Prerequisite For More Flexible Clinical Trial Designs: An Integrated eSource Solution

Those searching for a silver lining in the COVID-19 pandemic need look no further than the efficiencies newly embraced by the healthcare system in general, and clinical researchers more specifically. Worldwide, patients have come to expect the ability to interact with healthcare professionals from the comfort and safety of their homes. Remote data collection and telehealth practices have paved the way for more flexible clinical trial designs that collect data from sources beyond research site locations.

The life sciences industry is indeed making the shift from site-based studies to those that incorporate at-home data collection tools and remote study visits. There is a need to capture data directly from a variety of sources beyond the traditional paper source document, such as telehealth video and audio files, wearable sensors, laboratory data, vital signs, and digital forms completed by the patient or clinician. A solution exists to reduce complexity in clinical trial data collection allowing data to be entered directly into a database without any intermediary steps. Such automated, real-time means of data capture vastly improve the efficiency of data management in clinical trials and also support a patient-centric approach to trial conduct.

At this point in the evolution of clinical trial practices, Sponsors who delay adopting technologies capable of direct digitization of source data, or eSource, risk finding it even more difficult to recruit and retain patients. They’ll also miss out on the opportunities presented by electronic methods of source data capture to trim trial timelines and reduce costs.