The clinical trial and healthcare sectors are experiencing a massive shift, with technological advancements taking charge. As decentralised clinical trial (DCT) and hybrid study models take centre stage in clinical research, the role of DCT technologies such as electronic clinical outcomes assessments (eCOA) has become critical. The adoption of eCOA gained momentum during the pandemic as trial sponsors and CROs aimed at capturing accurate patient data remotely.
Let’s look into how eCOA, by augmenting patient recruitment and retention, is driving the fast adoption of DCTs.
Rethinking Paper-Based Patient Assessment
The healthcare industry is working to bring life-improving treatments to the market faster. It is important for trial sponsors to have a clear understanding of patient health status and treatment outcomes. However, the approach of assessing patients based on traditional paper-based PRO includes significant challenges. These include poor data quality and data integrity that hinder regulatory approval.
Data Quality Concerns
Health professionals need to have a good understanding of a patient’s overall health and quality of life. This helps them provide quality healthcare that is focused on the patient’s needs. However, the patient-reported outcome measures (PROMs) that document symptoms using the paper-based approach often lead to data quality issues—such as incomplete or ambiguous data, contradicting data, and the addition of superfluous data.
These data quality issues create challenges for the healthcare professionals who are handling trials. Also, it’s arduous and impractical to query these data. Moreover, data quality and accuracy issues with paper-based COA can persist even if data is collected under the direct supervision of an expert during a site visit.
A study found that about 44% of participants in a study on patient outcomes reported incomplete and ambiguous responses when using the SF-36 quality-of-life questionnaire.
Hampered Data Integrity
Ensuring participants document data in the PROM at the times required by the protocol is essential for data integrity. However, there are no automated reminders and notifications, or time/date stamps in paper diaries. Patients may find it challenging to remember to document symptoms and health status on time. It can significantly affect the fidelity of PROMs, leading to missing data and non-compliance.
In addition, the traditional paper-based COA increases patient burden while also impeding data compilation and analysis for the trial sponsor. In 2009, the FDA stressed the importance of maintaining PROM fidelity for data integrity and recommended CROs ensure patients document their health status at intervals detailed in the study protocol.
That said, the answer to the concerns associated with paper-based patient assessments is eCOA—an essential tool in the clinical trial sector that ensures patient centricity and data quality to support regulatory assessment and consent.
Making the Transition to eCOA
The eCOA technology refers to a collection of software and hardware components that facilitate the capture and management of patient-reported outcomes (PROs). The software component is the eCOA app installed on the electronic devices used for data collection. The hardware component includes the device itself. The hardware of eCOA is a collection of electronic tools and digital technologies, such as smartphones, sensors, wearables, tablets, etc. eCOA helps patients to accurately and comfortably document their health status and supporting clinical data in a DCT or hybrid trial setting.
How eCOA Helps
A more effective replacement for traditional paper-based data collection methods, eCOA helps clinical trial sponsors facilitate data collection, enhance data quality, and increase patient recruitment and engagement rates.
With trial sponsors striving to conduct patient-centric clinical research, eCOA technologies, such as “bring your own device” (BYOD), have emerged as a pivotal tool for efficient and time-saving patient assessment. Allowing patients to complete PROs with their own devices offers the flexibility to participate in trials from the comfort of their homes.
Citing FDA recommendation, leading virtual trial organisation (VRO), ObvioHealth also stresses the significance of collecting patient outcomes electronically. According to the VRO, the FDA supports the use of digital health technologies (DHTs) for capturing patient data, including mobile apps, to administer eCOAs in clinical trials.
In addition, sensors, fitness trackers, geolocation apps, and other electronic devices capture data on the patient’s health status automatically. This automated process of collecting passive/metadata gives context to each data item collected through ePRO, thus strengthening trial outcomes without adding any additional burden on the patients.
The implementation of eCOA in DCT models thus enables trial sponsors to capture accurate patient-specific data that ensures the therapeutic being rolled out is safe and effective enough.
Sohela is an electrical engineer and a self-professed writer with a keen interest in all things tech. When she’s not writing killer content pieces, you’ll find her enjoying tempting foods in her favourite restaurants.