艾昆纬-eCOA商品化的科学风险（英）

White PaperThe Scientific Risks of Commoditizing eCOA LINDSAY HUGHES, PhD. Principal, Patient Centered Solutions MELISSA MOONEY, Director, eCOA Solution Engineering DEBORAH STAPF, Senior Director, Clinical Technology OperationsTable of contentsBackground 1eCOA Science 1eCOA Technology 2Unique position of IQVIA 3Conclusion 5References 6About the authors 7 iqvia.com | 1BackgroundThe evolution of Clinical Outcome Assessment (COA) data collection from paper to electronic in the late 1990s/early 2000s offered several scientific and operational advantages in the clinical research space. Specifically, it enabled reliable collection of data outside of clinical site visits, reduced missing data, streamlined site and patient monitoring, and stimulated an increase in the use of COAs in clinical trials1,2. The advent of electronic Clinical Outcomes Assessment (eCOA) was informed by extensive research in which scientists explored what worked well, in an iterative fashion, using principles of behavioral science. This resulted in what we would now consider rudimentary technology. While technological advancements in recent years have certainly been exciting, this has coincided with a commoditization of eCOA that threatens the scientific rigor and quality underscoring its original intent. The full value of eCOA data can only be realized from the combined consideration of scientific quality and technological data capture (i.e., when the eCOA strategy is approached with the right level of scientific rigor needed to ensure implementation success). Herein we describe IQVIA’s end-to-end approach to the design and implementation of eCOA technology to reflect how we combine clinical and behavioral science with a focus on how people interact with technology.eCOA Science IQVIA has strategically invested in scientifically-robust eCOA solutions reflecting our commitment to science-forward eCOA implementation. Our behavioral scientists and eCOA scientists have a long history in this space; we have seen the gradual embrace of electronic capture of COAs over paper because of its ability to address administrative and patient burden, among other challenges experienced by Sponsors and CROs when using paper to collect COAs. We have direct feedback from patients, sites and sponsors of the benefits of giving patients and site staff the ability to enter data directly into a trial data capture system, which eliminates the need for entry from paper forms, which can lead to errors and requires a great deal of manual effort for entry and quality control. We have heard from regulators, payers and other data reviewers of the importance of ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) data, which is time- and date-stamped and ensures protocol adherence. While our scientific approach to eCOA may be somewhat unique in 2025, we must remember that eCOA was invented by scientists who understood human behavior to enable reliable collection of data outside of clinical s