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Guidance on the unique challenges presented by electronic outcomes.
It is widely accepted that electronic clinical outcome assessments (eCOA) are the preferred means of collecting participant data. In traditionally designed, site-based studies, eCOA has proven to be an effective method for capturing high-quality data while meeting all necessary regulatory requirements. Today, the use of electronic patient-reported outcomes (ePROs) and electronic clinician-reported outcomes (eClinROs), two of the most utilized eCOAs across all studies and all therapeutic areas, are commonplace.
While many eCOAs are still taken during in-person clinic visits, the flexibility of the electronic platforms proves valuable. This allows study teams to gather participant data, including regular quality-of-life measures, more frequently and cost effectively while maintaining compliance.
Digital collection and submission of outcome assessments are a natural fit for today’s decentralized clinical trials (DCTs). One of the key advantages of DCTs is the ability to expand participant recruitment beyond the geographical limitations common in site-based clinical studies. This allows sponsors to reach a much wider range of participants, including those living in rural areas located great distances from study center hospitals. This is significant, with more than 70% of clinical trial participants living two or more hours away from a study center. This is obviously beneficial for those seeking to conduct large, global studies while finding the most inclusive group of participants possible and is particularly useful for recruiting and enrolling optimized participant groups for rare disease trials. With DCTs, eCOA is useful in monitoring and managing participants spread out over great distances, as remote assessments help to minimize the number of in-person visits.
That said, global DCTs also present specific challenges for eCOA that should be considered and addressed to ensure study success. This article will discuss learnings and insights for sponsors conducting global DCTs
Security: Data security is a challenge for all industries that process and store data digitally. A recent poll taken of stakeholders in the clinical trials industry showed that 32% of respondents reported that concerns about data security was their primary barrier to using more digital technologies in clinical research. For DCTs and hybrid studies to work efficiently, data needs to be captured remotely from participants and other users, increasing both the risk of data incidents and the need for effective controls to maintain data integrity.
To keep data secure, numerous regulations and laws exist around the world that spell out the various approaches that need to be taken and safeguards that need to be in place. In healthcare, where data including personal health information is particularly sensitive, strict regulations must be acknowledged and followed. These regulations vary from country to country.
This can be a challenge for global trials, as the regulations for each country in which a participant lives must be adhered to. For example, in trials where participants live exclusively in the United States, all eCOA activity—ranging from participant-entered data to assessments recorded during telehealth visits, must be compliant with patient privacy regulations such as HIPAA (Health Insurance Portability and Accountability Act). For trials that involve participants living in the European Union and United Kingdom, GDPR (The General Data Protection Regulation) is an even more strict set of regulations designed to keep all personal data (not only health-related information) of EU citizens private and secure. GDPR equivalent regulations are now in place within Asia-Pacific countries as well.
Culture and language differences: When conducting global clinical trials, there is no such thing as one-size-fits-all eCOA. For each country represented by participants in a study, eCOA must be available in the appropriate languages and dialects. To maintain content validity, there needs to be a consistent presentation for all languages. Simply translating from one language to another is not realistic—validated eCOA has approved translations for use which have gone through rigorous equivalence testing. Thought must be given to how each language will reflect in the presentation of the eCOA instrument and how this will be impacted on screens ranging in size from smartphone screens to laptop and desktop monitors. Each language must be presented in a way that maintains the validity and intuitiveness and ease-of-use of eCOA applications. At the same time, content needs to mirror how the user actually speaks while avoiding terms or words that might be offensive in certain regions of specific countries. In any case where a translation does not exist, and where approval of the new language is not required by the scale author (e.g., questionnaires, surveys, eDiaries, etc.), it is useful to seek out translation vendors who can provide linguistic validation to ensure that the proper meaning and intent of the content is in place.
The translation process should not be underestimated; such processes can be complex. Choosing experienced vendors to manage this process on your behalf can simplify the experience for you and reduce or eliminate any potential language-specific user issues. Following is an example of a translation workflow for eCOA:
These steps will need to be repeated for every language—and dialect of each language—involved in the study. For large, widespread global studies, this is quite an undertaking. The right translation vendor, again, can help manage and simplify this process.
Despite the previously mentioned challenges, eCOA is an accepted interface for global data collection and is a standard feature within DCT. eCOA can be conducted in a variety of ways while maintaining the “fit-for-purpose” validation requirements set by regulators. For example, a majority of eCOA can be conducted via virtual telehealth visits that are device agnostic, do not require provisioned devices, and allow the users (participants, caregivers, home health nurse, etc.) to be anywhere while conducting the assessment. This adds flexibility to the process while meeting all eCOA license holder requirements such as user interface specifications, form factor restrictions, and process steps.
eCOA, combined with specialized telehealth platforms, can digitally recreate much of the in-person visit experience. Using the video and audio recording capabilities of a standard handheld device, for example, assessments of participant movement and vocal characteristics can be made remotely.
To realize the benefits of eCOA in global decentralized and hybrid trials, we must overcome the security, privacy and user-related challenges discussed earlier. Having helped sponsors and CROs (contract research organizations) perform hundreds of DCTs over the years, THREAD has developed some best practices for how to optimize eCOA in these studies.
Seek out systems with built-in privacy and security: Countries around the world present different sets of regulations regarding data security and privacy. Some are more stringent than others, so it is important to ensure that any software or platform vendors adhere to the most stringent regulations across your trial portfolio, irrespective of where any one single study is being conducted. eCOA platforms that are designed from the ground up with this in mind can help to address these differences. For example, GDPR is one of the strictest sets of restrictions regarding personal data in the world. By developing an eCOA platform that meets the strict standards of GDPR, a vendor will also meet or exceed any other sets of less-stringent regulations used in other parts of world. An example would be a vendor who utilizes advanced tokenization strategies to effectively mask all personally identifiable information (PII). Tokenization is a process by which PII is collected, only when necessary, directly from the participant and then immediately tokenized—or masked—and encrypted. In this way, all participant identification data is obscured immediately and completely.
Going digital also raises concerns around what security standards are applied to your data sets and what measures need to be taken to minimize data incidents. Choosing platforms built from the beginning with a cloud infrastructure can protect data from breaches.
Provide localized expertise and support to help global DCT eCOA run smoothly, study leaders should involve local experts and support in the regions of the world where participants are located. This helps to mitigate regional challenges like navigating country-specific regulations, different languages and dialects, and cultural norms.
Local knowledge enables sponsors—and any vendors helping them to conduct studies—to be aware of any changes in the regulatory landscape before they occur. This is essential to keeping each region involved in a global trial running smoothly.
Language translation and use of correct regional dialects are much easier to achieve if you have native speakers on the ground in those areas. These professionals—who can be employees or contractors—can help to confirm that the language has been accurately translated in a way that preserves the intent and meaning of the eCOA application while respecting any and all relevant cultural idiosyncrasies of the participant population. This is true for eCOA application content, of course, but also is necessary for all participant/user study materials including training manuals, interface user guides, process walkthroughs and more.
Region-based 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 access to expert support in the native language and dialect helps to solve issues quickly and keep participants on track.
Use participant-friendly, intuitive technologies: Easy-to-use technologies are a must for successful eCOA in any type of study. For global studies, intuitive interfaces are critical to keeping the stream of eCOA data flowing. Comprehensive applications anticipate the most common needs of users and offer a focused user interface similar to those found in the kinds of consumer applications that the study population is already familiar and comfortable with. Intuitive interfaces reduce the need for user training and minimize the potential for human error. Structured screen presentation helps to onboard new users, guiding them through instructional screens that serve to educate them on what is required for study participation. Moving later into the study, the same kind of screen flow and support functions help guide the eCOA process itself.
Offer built-in, on-demand user support: Another advantage of electronic assessment applications is their ability to house a wealth of easily accessible support content. Users can access content like videos, diagrams, or text on a variety of topics, such as:
Handheld devices, such as smartphones and tablets, are particularly useful at providing bite-sized content. This utility is a perfect fit for providing clinical trial participants and other users of eCOA applications, quick, image-heavy resources to support them over the course of a study. This helps them to address potential issues before they become problems and can help reduce the need for clinical team outreach, saving time and cost.
Chris Watson, Director of Consulting for THREAD