In recent years, life sciences organizations have been looking for a standardized approach to collecting global patient data while maintaining compliance and adhering to study timeline milestones. For clinical trials launched across multiple regions, time zones, and patient populations, the digital revolution toward decentralized clinical trials has caused a colossal shift from collecting patient data via paper patient-reported outcomes (PROs) to an electronic format. Now, more than ever, sponsors aim to empower the global patient voice through patient-centric technologies—including providing wearable technologies and using electronic clinical outcome assessments (eCOAs) to collect patient data.
Global Challenges for eCOA Migration
One of the largest challenges companies running clinical trials face is the complexity of developing an eCOA strategy for digital patient data collection. From navigating the complex world of authors/copyright holders of the instruments to validating multilingual instruments for ensuring data integrity, managing multiple parties in the room, and selecting an eCOA solutions provider that is up to industry standard for localization deployment, all of these factors (and more) directly feed into the complexity that is eCOA data collection. Changes in the COA/eCOA landscape have illustrated the need for centralizing global content solutions for eCOA migration to streamline and simplify patient data reporting, regardless of where a clinical trial is being conducted.
Benefits of Centralizing Content for eCOA Migration
Whether you’re a sponsor or CRO, there are three main benefits to centralizing global content for eCOA migration:
1. Reduce Time to First Patient First Visit (FPFV)
- Centralized Communication of All Parties:
- Centralizing the management of eCOAs and electronic patient-reported outcomes (ePROs) helps to resolve fragmented communication, enabling an improved relationship between translation providers, eCOA vendors, CROs, and sponsors. Doing so ultimately builds trust between stakeholders and makes for a smooth study launch, which can prevent project delays for future studies that affect FPFV and ethics committee (EC) submission dates. In addition, using an online tracker to access real-time study timeline updates per country is a great way to keep track of hitting FPFV/EC deadlines.
- Meeting Industry Best Practices in eCOA Migration/Localization:
- Beyond centralized communication, it’s also important to ensure that your eCOA vendors are up to date with industry minimum standards in localization best practices to contribute to an aligned project start. Each eCOA vendor has their own software architecture and capability of automation in the localization process. Your eCOA vendor and translation provider should be aligned on processes and work out any challenges before starting projects together.
- Safe, Secure Document Management and Automated Testing Environments:
- Leveraging a central, cloud-based platform can lead to 2.5x faster translation and eCOA migration and enable you to test directly on mobile devices, add and edit translations in real time, and auto-sync translatable content.
2. Ensure Regulatory and Legal Compliance
While there’s no specific global regulation that outlines requirements on eCOA migration, organizations such as the FDA, ISPOR, EMA, and others have all released best practices and guidelines to ensure patient data is validated, accurate, and high quality, regardless of the language it is recorded in. By centralizing content, sponsors and CROs are better positioned to address any errors in the initial paper instrument before electronic migration and before adapting to other languages.
Besides following regulatory authorities’ best practices and guidelines, it’s also imperative to get approval from the COA copyright holder (if applicable). Since clinical outcome assessments are intellectual property, any changes (including electronic adaptation and translation) must be approved by the license holder to ensure compliance.
3. Mitigate Risk
Centralizing eCOA migration activities has benefits beyond reducing time to market and mitigating risk.
- Initial Quality Assurance Check: Prior to commencing translation or migration work on an electronic platform, it’s important to do an initial quality assurance check on all English content in patient data collection instruments. Severe errors in these source files could impact the patient’s understanding and ability to answer the questions. By identifying the error in the source file, risk to data integrity is mitigated not only in English but in other languages as well. Just be sure to get permission from the copyright holder if a change is required!
- Library and Version Management: Translations per language cannot be recreated; however, with ever-changing technologies, the need to migrate existing paper translations onto eCOA platforms is multiplied tenfold. Having a modular approach to electronic localizations and a secure, organized library will help you maintain integrity in quality and version control to enable content reuse across multiple studies.
If you’d like to learn more about TransPerfect’s eCOA migration technology platform, which can deliver up to 50% shorter eCOA/ePRO migration timelines, reduce migration errors by 97%, and save 25-50% on rush charges, contact us today!