As clinical trials become more complex, the use of electronic clinical outcome assessments (eCOAs) is increasingly important for collecting and securely storing patient data. eCOAs use smartphones, apps, or web-based platforms to capture real-time data on patient experiences, including symptoms, adverse events, and the effect on a participant’s quality of life.
eCOA also captures various other types of electronic data, including patient-reported outcomes (ePRO), clinician-reported outcomes (ClinROs), observer-reported outcomes (ObsROs), and performance outcomes (PerfOs).
Critically, eCOAs integrate multiple types of assessments, each requiring different technological and methodological approaches. For instance, ePRO might require a simple patient input interface, while ClinROs may need more complex features.
By integrating eCOA with other clinical trial tools, such as interactive response technology (IRT) and eConsent, sponsors can streamline data collection and management, reduce trial complexities, and improve overall trial execution.
eCOA platforms offer a range of benefits, including improved data quality, time and cost efficiencies, increased compliance, improved patient safety, and enhanced trial performance.
However, the use of eCOA presents several challenges. These include managing multiple software applications, the need for standardization of data, regulatory compliance, and patient engagement. Additionally, precise data management and interpretation are essential for its successful implementation.
The rise of digital platforms in clinical trials
Covid-19 significantly impacted the healthcare industry’s digital transformation. During the pandemic, uses of technology increased in decentralized clinical trials (DCTs), featuring telemedicine, wearables, cloud computing, big data, and AI. Advantages included improved data collection, convenience, cost savings, and increased accessibility to underrepresented populations.
Indeed, according to a recent GlobalData report, Digital Transformation and Emerging Technologies in the Healthcare Industry 2023, over 80% of surveyed healthcare industry professionals stated that the pandemic sped up the digitalization process of clinical trials.
Furthermore, GlobalData research shows that between 2004 and 2021, over 4,900 clinical trials utilized virtual or digital components, such as eDiaries, activity trackers, telemedicine, mobile applications, smartphones, home nursing, ePRO, and eConsent.
Some study areas have used DCTs to address specific challenges. The use of digital technologies in oncology-focused studies is enabling rigorous safety monitoring of potentially severe side effects of trial drugs while expanding the reach of patient pools. Digital technologies have also been reported to help reduce the emotional and physical burden on patients when visiting trial sites.
Yet there remain challenges to overcome when working with large amounts of confidential patient data, while ensuring authenticity, and integrity, as well as compliance with many regulatory issues.
Ensuring the quality and standardization of data collected through eCOA is crucial. This includes addressing issues such as incomplete or inconsistent data entry, transcription errors, and data variability. Implementing measures to prevent these issues and flagging quality concerns in real-time can be a challenge. Data collected via eCOA must also comply with regulatory requirements. This requires data that is attributable, legible, contemporaneous, original, and crucially – accurate.
Additionally, the technological load has shifted from hardware to software. As sites expand their internal hardware capabilities, they must cope with diverse software programs and logins from various sponsors.
Despite these challenges, the adoption of technology in clinical trials is expected to continue to grow, driven by the need for more efficient and inclusive trial processes.
However, some patients can find using technology difficult, due to lack of experience with tech, security fears, or dexterity issues.
Increasing patient engagement and delivering successful outcomes
Due to their complex and time-consuming nature, traditional methods of gathering patient-reported outcomes frequently produced low participation and significant dropout rates. Furthermore, participants in clinical trials can frequently find it difficult to remain engaged with their study.
By utilizing smartphones as tools for engagement, sponsors can enhance the consumer experience. For example, Datacubed Health has developed a patient-centric mobile app using behavioral science principles to boost engagement and motivation. Designed using gamified features, the app was praised by 83% of users for its speed, ease of use, and portability, allowing study questionnaires to be completed daily in just five minutes.
Yet some patients still find fully remote clinical studies isolating or less conducive to their specific needs. Alongside this, CROs and sponsors often prefer on-site trials for areas such as oncology or for newer types of treatment such as cell therapy. This is where a hybrid approach can be helpful, where patients can choose the most suitable engagement method for them. By accommodating both patient choices and ensuring reliable data gathering and security, the hybrid model approach can create the best of both worlds.
For sponsors too, remote monitoring can be challenging. To help, Datacubed has developed a platform with agile, flexible, actionable dashboards. Used in combination with sensors and wearables, a sponsor can access a set of standard reports that can be customized and exported for internal or external sharing, ensuring complete transparency. Additionally, study-specific reporting is also available.
An eCOA with built-in patient engagement
As a result of decentralization, sites now have more responsibilities in managing technology required by patients, such as remote monitors or sensors. However, there is a need today to move beyond alerts and reminders to offer a truly holistic solution designed to deliver better retention and compliance.
Kyle Hogan, CEO of Datacubed Health, warns that site operators must understand how these tools work and teach patients how to interact with them, otherwise CROs or sponsors risk becoming an IT helpdesk. Making full use of the data available is paramount to advancing clinical research.
The future of clinical trials lies in integrating advanced data analysis and technology, enabling more tailored patient care, and potentially transforming healthcare outcomes globally. By leveraging real-time data on consent, medication adherence, patient compliance, and engagement, it becomes possible for clinical teams, sponsors, sites, and CROs to identify and resolve issues quickly, to support successful outcomes.
“Our focus on eCOA and ePRO is more than a strategic choice,” adds Hogan. “It’s a commitment to empower researchers with tools that are not just innovative, but also integral to the advancement of medical research. For far too long, the lack of eCOA product features has failed to meet the needs of sponsors with unique protocol demands.
“With innovations like our posture diary, food diary, and cognitive tests designed for early diagnosis of frontotemporal dementia (FTD), we’re setting new standards in the industry. Datacubed is committed to redefining what’s possible in clinical data collection to meet the needs of each individual trial – rather than the other way around.”
To learn more about improving patient engagement in clinical trials, download the document below.
