Fast, flexible and proven, IQVIA’s industry-leading electronic clinical outcome assessment (eCOA) platform ramps up efficiencies, delivers real-time data, and sharpens insights through best-in-class technology and a better patient experience.
A complex trial landscape
Clinical trials focused on rheumatoid arthritis (RA) face several unique challenges, ranging from intricate study designs and numerous endpoints to increased site staff involvement and lengthy study duration. The chronic nature of RA and participants’ subjective pain experiences also raise the intricacy of these types of trials. Collecting input from patients on their pain levels, as well as clinicians’ assessment of disease activity, is critical to study success.
These demands often result in high volumes of electronic patient-reported outcomes (ePROs) and clinician-reported outcomes (ClinROs). In this context, electronic clinical outcome assessments (eCOAs) are vital instruments for collecting accurate, high-quality data and improving the site and patient experience during the trial. In this blog, we’ll examine the application of eCOAs in RA clinical trials, highlighting the impact on study conduct, outcomes and participant experience.
Driving data accuracy and consistency across RA trials
A key objective and endpoint in these studies is the ACR (American College of Rheumatology) index, which is represented by a composite of several metrics used to measure disease progression and treatment effectiveness over time. Primary among these measures is the tender and swollen joint count (TSJC), for which a clinician evaluates a patient according to 68 individual joints in the body.
Providing clinical sites, sponsors and medical monitoring groups visibility into TSJC scores over time is paramount to the success of these studies. To improve the reliability and efficiency of these scores, we have developed an easy-to-use digital interface that automatically calculates the TSJC following a clinician’s input. Data points are captured in a way that aligns with the workflow associated with how clinicians typically perform the examination. This saves time and effort and alleviates site burden by removing unnecessary workflow steps while ensuring data accuracy. Furthermore, custom reports are available to sites and study teams to provide visibility into scores across visits. These reports are intended to support clinical decisions around eligibility and disease progression at key timepoints.
Driving consistency across trial sites is also vital to trial success. IQVIA experts are available to support the development of comprehensive, study-specific training designed to ensure clinicians are evaluating patients and completing ClinROs in a consistent manner across sites.
Partnering with sponsors to meet RA challenges
At IQVIA, we bring decades of deep experience in supporting sponsors, sites and patients in rheumatology studies. We continue to work with sponsors at the earliest RA trial stages to understand their needs and meet these challenges, ultimately helping them offer therapies to patients more quickly. These collaborations have shaped our eCOA platform into a solution tailored to the needs of RA trials, focused on usability, accessibility and operational fit.
Key features of our eCOA include:
A leading eCOA solution that ensures results
IQVIA continues to be a trusted partner and advisor in RA trials. From 2016 to 2023, every approved rheumatology drug involved our expertise, including those for RA. We provide sponsors with end-to-end solutions that fully capture vital patient experience data, ultimately contributing to the success of these trials.
Specifically, implementing the IQVIA eCOA solution in RA studies yields significant benefits:
Looking to a future of continuing innovation
As RA research evolves, so does our commitment to delivering technology that works for everyone — sponsors, sites and patients. We remain focused on improving data quality, access and timeliness. Our eCOA team keeps improving RA trial experiences and study outcomes. Our commitment to innovation is designed to simplify clinical trial execution and accelerate the delivery of better therapies to patients who need them most.
To learn more about how IQVIA eCOA can improve patient outcomes in your next RA trial, please contact us today.
Fast, flexible and proven, IQVIA’s industry-leading electronic clinical outcome assessment (eCOA) platform ramps up efficiencies, delivers real-time data, and sharpens insights through best-in-class technology and a better patient experience.