Guides
How to improve eCOA data quality in clinical trials
Electronic clinical outcome assessments (eCOA) have become essential for modern clinical trials, offering numerous advantages over traditional paper-based methods. However, the benefits of eCOA can only be fully realized if the data collected is of the highest quality. Ensuring data quality in eCOA clinical trials requires a multifaceted approach, encompassing platform design, patient engagement strategies, robust data validation procedures, and strict adherence to regulatory guidelines. This blog post explores key strategies for achieving and maintaining data quality throughout the eCOA process.
Back to Basics: What is a decentralized clinical trial?
In a decentralized clinical trial, part or all of the protocol occurs away from the primary study site. Instead of patients traveling, often repeatedly, to a central site for enrollment, consent, data collection or symptom monitoring, they can participate in telehealth visits from their homes, often using familiar technologies, like smartphones, tablets and wearables to transmit pertinent information. Even medications and devices can increasingly be delivered directly to a patient’s home, and a home visit from a health care professional can be arranged if necessary.
Back to basics: How digital and decentralized clinical trials enable trial diversity
The advancement of decentralized clinical trials (DCTs) allows patients to participate without having to travel to a trial site, removing many barriers that may have hindered people of diverse backgrounds from participating.
Back to basics: How hybrid and decentralized technologies impact each phase of the clinical research journey
Clinical trials require volunteers to assess medical products like devices, vaccines, or medications for efficacy and safety. For health equity to be achieved, it’s imperative that clinical trials include people from diverse backgrounds so as to represent the global population of patients using the products.
Back to Basics: Remote patient monitoring
Remote patient monitoring programs and technologies are becoming increasingly popular, backed by growing clinical evidence showing numerous benefits to patients and providers. While remote patient monitoring (RPM) isn’t new, it’s evolving quickly due to the regulatory push to expand access to care during the COVID-19 pandemic. Coupled with the fact that the digital health market is poised to more than double by 2026, providers and patients have a greater ability to track vitals between visits, and both centralized and decentralized clinical trials rely on remote data collection now more than ever. While there is tremendous potential upside, some barriers and risks are inherent in this digital process. Human-centered design and strategic implementation can ensure that RPM in clinical trials is both beneficial and cost effective.