This blog is a summary of an Apr 15, 2025 Applied Clinical Trials webinar featuring Transperfect’s Mark Wade, a Global Practice Leader Life Sciences, COA SME, and our own Cindy Howry, VP, eCOA Science Science and Research.
With MarketsandMarkets projecting the global electronic Clinical Outcome Assessments (eCOA) solutions market to grow at compound annual growth rate (CAGR) of 16.1% each year until 2030, it’s clear the eCOA has made its impact within the clinical research landscape.
Yet despite growing adoption, electronic Clinical Outcome Assessments (eCOA) are still surrounded by misconceptions that hinder their full potential. From concerns about patient usability to assumptions about cost and implementation timelines, these myths can create hesitation among sponsors and research teams alike.
Thus, we’re here to cut through the noise and set the record straight with a summary of a recent webinar featuring speakers from Transcelerate and Medable.
Myth 1: Translation processes are a bottleneck for eCOA timelines
Clarification: While translation remains a resource-intensive endeavor, some providers are strategically mitigating its impact on project timelines using technology.
This is because many modern clinical trial platforms facilitate the re-utilization of pre-built assessments, complete with validated translations and Certificates of Translation (COTs). For sponsor organizations with established program-specific libraries, this approach dramatically curtails re-translation efforts, especially for well-established instruments that have undergone no modifications. Here, modern platforms integrate generative AI for an initial conversion of paper-based electronic versions, followed by meticulous character mapping and review.
While recognizing the inherent value of language asset reuse, it is critical to acknowledge the prerequisites of copyright holder endorsement and rigorous version control. However, a significant number of studies continue to involve de novo instruments. These are proprietary tools for which no prior translations exist. In such instances, the comprehensive, validated translation process remains indispensable and time-consuming. The collective aim is to alleviate translation as a singular critical path item, recognizing that other factors also influence overall timelines.
To dispel this myth, organizations should explore eCOA platforms with robust, pre-validated libraries and integrated translation management capabilities to streamline the linguistic validation process.
Myth 2: You must have an eCOA library to have a successful, streamlined launch
Elaboration: While undeniably beneficial, eCOA libraries are not required for every translation need.
A robust eCOA library, coupled with role-based access for authors and license holders, strategically streamlines study initiation by providing readily available, pre-built assessments. This functionality can compress setup times from weeks to mere days for instruments already cataloged within the library.
However, if an instrument is newly developed and lacks existing translations, the full linguistic validation and migration protocol remains a necessary step. The strategic imperative is to discern when existing, meticulously controlled translations can be leveraged versus when a new translation process is warranted.
Organization's trial teams should collaborate closely with their eCOA and translation providers to understand the specific validation requirements for each instrument. Furthermore, it is advised to firmly adhere to validated versions of instruments, discouraging unauthorized wording alterations without proper author involvement and re-validation.
Myth 3: Using eCOA technologies consistently requires 16-18 weeks of time
Clarification: Advanced eCOA building platforms are demonstrably accelerating study go-live timelines. To see an example of a case study that shows how, click here.
An expedited eCOA builder, powered by integrated AI, enables real-time screen construction and immediate export for screenshot review. This capability substantially reduces design cycles, facilitating more rapid iteration and approval processes. The platform natively incorporates functionalities such as anchoring text, unit measurements, conditional question logic, and scrolling preferences, representing a significant leap beyond conventional, labor-intensive, module-by-module programming methodologies.
Organizations should prioritize eCOA solution providers that offer intuitive, AI-powered builders to compress development timelines and expedite study launch.
Myth 4: Paper-based data collection is experiencing a resurgence in eCOA.
Correction: While paper has never been entirely phased out, its role is diminishing, and it does not represent the future of data collection.
Paper has continued as a contingency, particularly in scenarios involving technology failures or insufficient site training. The onus is on eCOA providers and translation entities to consistently demonstrate that electronic data collection, despite any initial implementation hurdles, offers superior efficiency and reliability in the long term.
It is crucial to understand that reliance on paper often stems from inadequately designed electronic studies that lead to data loss. Selecting experienced eCOA providers, particularly those actively engaged in collaborative industry initiatives, is paramount to ensure robust study design and minimize the need for paper-based fallback.
Myth 5: eCOA technologies increase both patient and site burden
Correction: This myth often persists due to early experiences with poorly designed eCOA systems that lacked user-friendly interfaces and didn’t integrate well with site workflows, leading to frustration for both patients and staff.
Resistance to change also plays a role, as sites and participants familiar with paper methods may be hesitant to adopt new technology, especially if the learning curve feels like an added burden. Inadequate training and limited technical support can further reinforce negative perceptions, making minor issues seem like major obstacles. Additionally, there's a common misconception that more frequent data collection means more work, when in fact, eCOA systems are designed to streamline processes and reduce manual effort through automation.
However, modern eCOA solutions are meticulously designed to significantly reduce patient burden by offering unparalleled flexibility and convenience. Patients can complete assessments anytime, anywhere, using their preferred devices, eliminating the need for burdensome clinic visits solely for data entry. Organizations should prioritize platforms with flexible access options, including Bring Your Own Device (BYOD), to cater to diverse patient lifestyles.
These platforms also feature intuitive user interfaces, simplifying data entry even for those less tech-savvy. To prove this, your organization should insist on demoing the patient-facing interface during vendor selection to ensure ease of use and minimal cognitive load. Automated reminders and notifications further ease the patient's mental load, promoting timely data capture and reducing recall bias, which benefits patients by minimizing the stress of retrospective reporting. Therefore, design protocols that leverage real-time data capture to enhance data quality.
Finally, advanced eCOA solutions often include essential accessibility features, such as customizable font sizes and screen reader compatibility, ensuring inclusivity for all participants. If applicable to your patient population, consider solutions that offer caregiver support and dedicated logins for observer-reported outcomes to further minimize patient effort.
Beyond patient benefits, eCOA technologies are equally transformative in reducing site burden by streamlining numerous operational aspects. The elimination of manual data transcription is a prime example; data is captured electronically at the source, saving considerable time and reducing errors. Organizations should quantify these time savings when evaluating eCOA's return on investment. Furthermore, site staff gain immediate access to patient-entered data through real-time visibility, allowing for proactive monitoring of compliance and prompt identification of potential issues; leverage real-time dashboards and reporting features to enable this. Automated data queries and validation, built into eCOA systems, significantly reduce the time-consuming process of manual data cleaning, so collaborate with your eCOA provider to define robust validation rules upfront. Workflow efficiency is also enhanced through integration capabilities with other clinical trial systems (e.g., CTMS, EDC, IRT), which reduces redundant data entry and multiple logins. Prioritize eCOA platforms offering strong integration. Finally, with remote data capture and real-time monitoring, the frequency of on-site monitoring visits can often be reduced, freeing up valuable site staff time. Discuss optimized monitoring strategies with your CRO and eCOA provider, and always ensure the chosen vendor's training and 24/7 technical support plan is robust and accessible, as it's critical for successful site adoption.
As market share increases, myths will decrease
As the eCOA landscape continues to evolve, it’s crucial that industry stakeholders separate lingering misconceptions from evidence-based practices. The insights shared by Transcelerate and Medable highlight how innovation, strategic implementation, and collaboration are dismantling outdated beliefs about eCOA.
With the market poised for continued growth and modern platforms addressing historical pain points head-on, now is the time for sponsors and sites to fully embrace the efficiency, flexibility, and data integrity that eCOA can deliver. Dispelling these myths is not just about adopting new technology, it’s about advancing the future of clinical research.
To get a demo of Medable’s eCOA capabilities, or to speak with an eCOA expert, click here.
