Making Global Local: Tips for Localizing eCOA in Your Global DCTS
eCOA is a common and accepted methodology for global data collection and is among the most oft-used features of decentralized clinical trials (DCTs). One of the reasons eCOA is so useful is that it can be conducted in a variety of ways while maintaining the “fit-for-purpose” validation requirements set by regulators all over the world. That said, conducting eCOA globally with any kind of consistency means navigating the unique needs of each locality involved in the study. Each country brings its own challenges associated with language, cultural preferences and, of course, regulatory guidelines. Here are some steps to take to make sure your global eCOA strategy is positioned for success.
- Keep Privacy and Security Up Front Different countries and regions throughout the world present various and important differences in how they regulate collection and sharing of health data. To ensure that your studies will be prepared for even the strictest standards, work with eCOA software and platform partners whose systems are flexible enough to adhere to the broad range of global standards. GDPR, for example, is one of the most stringent sets of restrictions regarding personal data (not only healthcare-related) in the world. Partners who offer eCOA platforms that meet GDPR guidelines will, in most cases, also meet or exceed the regulations of other countries and regions. A good example would be a platform that masks and encrypts all participant identification data, obscuring the information immediately and completely, a strategy called tokenization. Utilizing eCOA, as with any solution that collects and stores data digitally, requires proper planning around data security. Attempts at information theft are common, so give careful thought around what security standards need to be applied to your data sets as well as what safeguards need to be in place to reduce the risk of data breaches or similar incidents. For example, does the country in question require localized data storage? Security by design principles in mind on a cloud infrastructure can help to protect data.
- Tackling Translation The translation process is complex. Validated eCOA translations need to be available in the appropriate languages and dialects for every country represented in the study. Once it is confirmed that the eCOA content is available and valid in each language, all supporting content must, likewise, be translated correctly. Content needs to reflect how the users actually speak, all while avoiding words or phrases that might be offensive to a particular culture. The right partners can help; seek out translation partners who can provide linguistic validation and guidance on how best to present the content to users.
- Local Experts for Local Support Experts in the regions and countries where your study is being conducted can help to mitigate a number of issues that could, potentially, cause problems with your eCOA collection. In global studies, one set of rules should not be applied to all countries. As such, local regulations need to be considered as early as possible during study planning. These regional differences will likely affect how you collect and manage study data. This issue is compounded when regulations are changed at a regional level. Local experts are able to provide an early indication of potential changes which may affect your studies, informing sponsors and allowing them to make any necessary adjustments to remain compliant. These experts – who may be the same team that helped to localize the translation of your eCOA content – can also be leaned upon to provide regional support. This support is critical for participants and other users (caregivers, clinicians, etc.) who may need assistance with the applications, the devices, or other challenges associated with their eCOA responsibilities. Providing a resource for participants to interact with in the same language and dialect helps to keep them retained and on track.
By considering these three steps while preparing to implement eCOA in your global DCTs, you can prepare for the most commonly faced challenges and create a foundation for study success. For more information on how THREAD can help you build effective global DCT programs, visit threadresearch.com.
Director of Consulting, THREAD
Chris is an experienced Product leader and clinical system specialist with over 21 years’ experience of product management. Combining practical experience of roles within clinical development with a keen interest in leveraging technology, a thought leader in eCOA solutions and patient-facing technologies, Chris is helping shape the direction and application of global eClinical solutions