Modern Obesity Trial: Best Practices for eCOA and Device Integration

Modernizing Obesity Trials:Best Practices for eCOA Table of contents Introduction1Background2Obesity: A highly patient-centric therapeutic area2 Introduction Obesity is a complex global health challenge, broad in scale yet deeply personalin impact. Effective clinical trials for obesity drugs must capture more than weightor BMI. They must incorporate real-time, patient-centered data on behavior, This outcomes research guide explores the roles of eCOA and connected devicesin obesity trials and explains how their integration drives more accurate, higher- IQVIA has been involved in the majority of obesity trials conducted in the pastfive years and has supported drug approvals for three major obesity drugs. Obesity: A highly patient-centrictherapeutic area Background The market for anti-obesity medications is growingat a record-breaking pace. In 2023, obesity ranked asthe fourth-largest area of global prescription drugspend, and in 2024, over $30 billion was spent on theseprescriptions. This spend is expected to grow to $131billion by 2030. Obesity isn’t just a growing global Understanding the obesity therapeutic area requires aholistic perspective, where capturing the lived patientexperience is as important as the quantifiable endpointsthemselves. Drop-out rates in obesity trials are higherthan in other trials, approaching 40%. Given thisdynamic, and its negative impact on trial success, patient Differentiation has become essential in such a fiercelycompetitive space. To stand out, sponsors often targetobesity-related comorbidities, as the disease contributesto a range of conditions. As companies compete, manyare turning to comorbidity-focused strategies (such as In this context, modern clinical trials in obesity requiretools that can capture both subjective and objectivemeasures. This makes integrating eCOA and connected eCOA allows for structured collection of subjectiveinsights directly from patients about their symptoms,appetite, mood and quality of life. Connected devices(such as wearables, smart scales, and continuous glucosemonitors) provide objective continuous physiological The number of obesity study starts spiked in 2023 and2024, with over 170 compounds currently in the pipeline.The complexity of this disease translates to complexityin conducting clinical trials. In this arena, sponsors must patient-reported outcomes that reflect real-worldexperience, strengthening the clinical relevance of trial In just the past five years, IQVIA hassupported over 80 trials in obesity,enrolling 60,000-plus patients in By capturing experiential insights, COA helpsresearchers and sponsors evaluate the true impact ofa trial, ultimately delivering more meaningful, patient-centered trial outcomes. The combination of obesity- Measuring the intangible:How eCOA drives clinical trial Traditional measures like weight, BMI and lab valuescannot fully capture how patients are responding totreatment or navigating trial challenges. eCOA fills thisgap by enabling electronic capture of patient experience The collection of digital outcomes adds valueacross all phases of the obesity trial lifecycle, Furthermore, eCOA plays a critical role in clinical trialsfor obesity drugs by improving accuracy, compliance andpatient engagement. With scheduled clinical outcomeassessments and reminder notifications, participantscan log behaviors such as diet, activity and mood in The subjective data points captured by eCOA oftenunderpin the primary and secondary endpoints thatprovide regulators with richer evidence of treatment In order to manage the complexities of global trialsinvolving eCOAs and multiple devices, sponsors areshifting attention beyond devices to integrated, From devices to insights:The role of digital health Clinical trials increasingly rely on digital healthtechnologies to support outcomes. Devices and wearable The power of eCOA and deviceintegration: Making trialsmore patient-centric This is especially true in obesity studies, where weare seeing multiple devices — up to five or more —combined to monitor patient safety and drug efficacy.Doing so provides a better picture of overall patienthealth and also helps assess the effects of therapies Deeper insights into patient experience lie at thecrux of success in these trials. Together, eCOA anddevices provide a complete view of the patient journey,capturing both how patients feel (subjective reports) Devices also reduce the need for site visits. Remote datacollection lowers patient burden, reduces dropout, andbroadens inclusion. As with eCOA, validated device data As we’ve noted, continued patient engagement is vitalto study success. Integration minimizes patient burdenwhile improving engagement by simplifying data entry,reducing site visits, and making daily monitoring routine.User-friendly platforms that combine eCOA and devicefeedback help patients maintain routines that are critical Technology keeps advancing, combining consumer-grade usability with