YP: What type of trends are you seeing related to eCOA?
Jessica: The major trend we’ve seen in the past 3 years is a shift from paper to electronic modes of administration and the growth with eCOA, along with e-learning, rater training, and on-device testing. That’s the direction we’ve seen the industry move toward.
Alexandra: The industry in general is moving towards electronic platforms, BYOD, and wearables. In the industry, there’s even more focus on COAs and their use in trials, just because patient centricity is really important. The FDA recently announced its dedication to patient-focused drug development (PFDD) and released a draft guidance. Overall, the industry is using more COAs than ever before and in turn, they are using more eCOA.
In the traditional process, linguistic validation is performed, translations are converted to text files, and then transferred to electronic formats (assuming equivalence testing has been completed). Are there opportunities to bring these processes together to eliminate a few steps?
Jessica: Absolutely. By involving a language service provider in the very beginning with the sponsor, CRO and eCOA provider, we’re able to help with study planning. Many times, the paper assessments aren’t really needed. Depending on the timelines we’re dealing with, performing linguistic validation directly into the device files, and then debriefing, using the screen shots can be sufficient for our clients’ timelines. This eliminates unnecessary work and potential risk with transferring to devices, while still meeting timelines for the study. As a general range, it can eliminate 3–6 weeks from a traditional timeline.
Alexandra: To add to that, our process with YPrime involves working directly into the native files. We don’t do the paper translation first. Instead, we integrate our process with YPrime, translating directly into the live native files, so the team can directly upload and create screen shots. Whenever possible, we try and use that process and those screens for cognitive debriefing. ISPOR guidelines suggest the patient see the questionnaire during cognitive debriefing as closely as they would during a real study, so if the study is going to be an eCOA study, the patients are being debriefed with screen shots and see exactly what they would see on the screen in the actual study.
What recommendations do you make to sponsors and eCOA providers on avoiding common pitfalls in the translation management process?
Alexandra: Obviously, making sure they are aware of the linguistic validation process. We recommend education through webinars and other materials – the linguistic validation process is lengthier than a standard translation, which may take a few days or a few weeks. In terms of eCOA, it’s really important to make sure the sponsor or CRO, translation company, and eCOA provider are really well integrated, so we suggest having a kick off call. A lot of people focus on the eCOA provider to get the English build ready and then pull in the LSP a few weeks later. Sometimes the English build may take 6–8 weeks to put together, but if the translation vendor is involved at the very beginning, we can plan on our end and help advise on process and workflows. That’s important. And then, leveraging TransPerfect’s relationships when coordinating licensing and developer reviews. Our Sr. Director of COA Consulting and her team manage all of the licensing support. If a developer requires review of text at some point, or the screen shots, it’s important they are given a heads up, as we commonly see that copyright holders add to overall timelines when they review materials. They need to know when to expect materials, and to integrate technology wherever possible. Having a discussion on the front end to see if there’s an appropriate technology solution for that project or study or client-level relationship.
How well would you say the Linguistic Validation process is understood?
Alexandra: It’s definitely getting better, compared to 5 years ago. It’s really dependent on the client and the team tasked with it. The HEOR/PCOR teams generally know what’s going on. If the clinical team is tasked with getting the COA translated, depending on what the company structure looks like, they might not have the background information in terms of linguistic validation. We do spend a great deal of time helping to educate clients on the process. Whenever files come in, we do vet them on our end. We make sure we actively have these discussions with sponsors and CROs. They understand when linguistic validation is and is not needed, and the risks and benefits of including or excluding it for their particular study.
Can you discuss translatability assessments and when they should be considered?
Alexandra: A translatability assessment is really part of the English development process, when you’re creating a new COA, a homegrown questionnaire that’s never been used before or translated into other languages. It is a recommended step in the English development process. What happens is, a client would give us an English questionnaire and a list of target languages, or we may take a sample of different types of languages, some from Asia, some from the Middle East, as well as Western and Eastern Europe, for example. We take that English version and work with linguists and resources in each of these countries to determine if any words in English will be problematic when translated. An example might be if a questionnaire asks about the use of medical marijuana. In any Asian country, this is not permitted (even for medical use), so you wouldn’t ask a patient about this because not only is it not applicable, but also potentially offensive. Another example is, “on a scale of 1-10, how difficult is it to blow dry your hair every morning?”. It wouldn’t be an appropriate question for someone in South Africa who may not be familiar with doing this frequently. You’d want to change the English to something more globally applicable or understand that in the language version, it will need to be culturally adapted on a country by country basis. A translatability assessment avoids those back-end issues during the translation process by making sure the English version is more globally appropriate than it would have been without the assessment.
Do you have any other recommendations for sponsors specific to eCOA translations?
Alexandra: Having a global picture is important. When there’s eCOA, there’s also eLearning, device testing, supplemental materials. Engaging the translation vendor is important, for the end-to-end support.
Jessica: As the supplementary industries are growing, it’s important that we are engaged and contracted on a study level so you’re able to have consistency across your study. Knowing about all of the components at the onset is important to overall success. Specific to eCOA, one of the major contributing factor to overall success or failure is how the device build is created. A standardized build can help eCOA clients with success across all studies because they are not reinventing the wheel each time, and can see cost and timeline savings with the efficiency gains that standardization brings.