eCOA产品化的科学风险

Table of contentsBackgroundeCOA ScienceeCOA TechnologyUnique position of IQVIAConclusionReferencesAbout the authors 1123567 iqvia.com | 1into a trial data capture system, which eliminates theneed for entry from paper forms, which can lead to errorsand requires a great deal of manual effort for entry andquality control. We have heard from regulators, payersand other data reviewers of the importance of ALCOA(Attributable, Legible, Contemporaneous, Original andAccurate) data, which is time- and date-stamped andensures protocol adherence.While our scientific approach to eCOA may be somewhatunique in 2025, we must remember that eCOA wasinvented by scientists who understood human behaviorto enable reliable collection of data outside of clinicalsite visits, streamline site and patient monitoring, and,most importantly, reduce missing data. A seminal articleby Stone and co-authors2describes a study in whichpatient compliance was measured empirically on papervs. eCOA. This study is often cited as a justificationfor the superiority of eCOA over paper because of itsvery compelling findings: paper compliance within thespecified window was 11% as measured by a discreetsensor that captured patient activity. In comparison,patients using an electronic version that had beendesigned to improve compliance achieved 94%. Thisstudy, published in 2002, reflects the type of hypothesistesting necessary to establish and refine tools that arepatient centered. This is one of many similar examples ofsuch research done in the early 2000s to drive continuousimprovement of system design based on an applicationof empirically-supported learning that improved patientcompliance with the protocol and ultimately, improveddata quality. BackgroundThe evolution of Clinical Outcome Assessment (COA)data collection from paper to electronic in the late 1990s/early 2000s offered several scientific and operationaladvantages in the clinical research space. Specifically,it enabled reliable collection of data outside of clinicalsite visits, reduced missing data, streamlined site andpatient monitoring, and stimulated an increase in theuse of COAs in clinical trials1,2. The advent of electronicClinical Outcomes Assessment (eCOA) was informed byextensive research in which scientists explored whatworked well, in an iterative fashion, using principles ofbehavioral science. This resulted in what we would nowconsider rudimentary technology. While technologicaladvancements in recent years have certainly beenexciting, this has coincided with a commoditizationof eCOA that threatens the scientific rigor and qualityunderscoring its original intent. The full value ofeCOA data can only be realized from the combinedconsideration of scientific quality and technological datacapture (i.e., when the eCOA strategy is approachedwith the right level of scientific rigor needed to ensureimplementation success). Herein we describe IQVIA’send-to-end approach to the design and implementationof eCOA technology to reflect how we combine clinicaland behavioral science with a focus on how peopleinteract with technology.eCOA ScienceIQVIA has strategically invested in scientifically-robusteCOA solutions reflecting our commitment to science-forward eCOA implementation. Our behavioral scientistsand eCOA scientists have a long history in this space;we have seen the gradual embrace of electronic captureof COAs over paper because of its ability to addressadministrative and patient burden, among otherchallenges experienced by Sponsors and CROs whenusing paper to collect COAs. We have direct feedbackfrom patients, sites and sponsors of the benefits of givingpatients and site staff the ability to enter data directly 2 | The scientific risks of commoditizing eCOAThe availability and power of technology has changeddrastically from the early days of eCOA. The IQVIA eCOAsystem is a far cry from the Palm Pilots used in theStone study and makes use of the extremely powerfulsmartphones that most of the global population iscarrying around every day. But that they carry themdoes not necessarily mean that people will engagewith them in a systematic manner to complete PROsas required by a study protocol or requested by theirclinician. We must continue applying behavioral scienceprinciples to really understand how people use andengage with technology so that we can continuouslyimprove and tailor eCOA solutions to maximizecompleteness and reliability of data. We don’t know whatwould happen if the Stone study was redone in 2025.We do, however, know that this research is not routinelyhappening across the industry. While conductinga literature review for a forthcoming publication,IQVIA found very few empirical studies that test bestpractices or explore what we could be learning fromelectronic implementation by conducting researchfrom recent years. Rather, literature tends to focus onconsensus-driven best practices. Moreso, non-scientificliterature, such as white papers, commonly focus ontechnology, speed, and