SCOPE Europe 2023: Integrating eCOAs and DHTs

Mikulaschek: I think when you take a look at applying eCOAs to clinical trials, the data is incredibly important, so there's several disciplines involved in being able to effectively gather that information. This is going to be a be multiple-layered answer for you, so initially you have to understand what data you're collecting and why you're collecting it and some of the things I talked about earlier this morning and that is a sponsor and the protocol needs to have a very clear understanding of what information it requires; you don't get too much information or you burden the patients too much so the overall eCOA strategy is incredibly important for the individual protocol or the actual clinical program that the sponsor is developing, so it starts there. Once that's defined, the implementation of those eCOAs to be able to collect the data. You asked about a challenge, so thinking about the technology of taking that questionnaire and putting it into a platform, that technology challenge really isn't there anymore, it was 10-15 years ago, there's a lot of platforms out there that you can do click and drag. Ours in particular, it's really easy for us to develop eCOA, we can typically do it in less than 24 hours; a very complex one, that's the easy part. What gets a little bit more complicated that the industry needs to keep focusing on; there's two things: one, reading the protocol and understanding the events and the actions that are needed for the subject and for the site, there’s ClinROs and ePROs in there, so what's the most effective way for the clinician to be able to collect their information or for the patient to be able to collect their information? So those trial events are really important, then the next thing that the industry is currently facing, not exactly facing, but it’s challenging for everybody, and that is we're dealing with localization and translations of COAs and making sure that you stick true to the instruments and you go through a linguistic validation process in the timelines associated with that. One of the things that we try to do is make sure that we get the correct translation, we implement it correctly within our system, and then that allows us to reuse that translation if it's a public domain instrument and that helps reduce that timeline, but it takes time to develop the library that has those types of information, and it's important to gather the the translations, and as a sponsor goes and looks at the community and the diversity requirements for a clinical trial, it just expands the need to be able to gather those translations and manage the translations to make sure they have the correct meaning behind those COAs, so I think those are the two predominant challenges that we have is that the value chain to get it implemented and then the actual, “Let's just start with the strategy.” FDA and EMA are putting an emphasis on gathering the voice of the patient, so we all have to do that. It makes sense, so you have to have that strategy defined upfront.