By Celeste Elash, Director, eCOA Sciences
With acceptance of personal electronic devices (e.g., smartphones and tablets) by the public, the use of computerized systems to collect clinical outcomes assessment (COA) data in clinical trials is commonplace and becoming the preferred and recommended method. The advantages of electronic data collection over paper are numerous and well documented in the literature, and when well applied, can result substantial trial cost savings. This movement toward electronic data collection has enhanced the quality and accuracy of clinical trial data and the and regulators are encouraging electronic instead of paper-based data collection.
The 2016 Century Cures Act, which includes sections devoted to streamlining patient input and using patient experience data in drug development, builds on FDA's work to incorporate patients’ perspectives into the development of drugs, biological products, and devices and helped focus drug development on patient-focused outcomes. In 2017, former FDA Commissioner Dr. Scott Gottlieb stated “Our aim is to facilitate the development and use of patient-focused methods in more parts of our regulatory activities as well as develop and elevate common standards for how to integrate the patient voice, as a matter of science, into product development. Among some of the long-term goals of these new efforts is the creation of consistent approaches to how the FDA develops clinical outcomes assessment tools such as patient-reported outcomes to inform our regulatory decisions.” With the reissuance of the Prescription Drug User Fee Act (PDUFA), patient engagement was elevated to be a core part of the FDA’s regulatory approvals process.
Electronic COA (eCOA) is central to patient-focused drug development. As the regulators continue to encourage its use in clinical trials, eCOA deployment will continue to evolve. Hot eCOA topics that demonstrate the trend toward patient-centricity are described here.