In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data and analytics officer at WCG, discussed the challenges in the clinical trials industry and highlighted the lack of awareness among both patients and healthcare professionals. I emphasized. He highlighted operational issues such as difficulties in patient identification and engagement, data interoperability, and ensuring data quality. Mr. Galea emphasized the importance of user experience and the need for industry standards in electronic data capture tools. Data collection prioritization should focus on safety, effectiveness, efficiency, ensuring data quality, and avoiding workflow disruptions.
A transcript of Galea’s conversation with ACT can be found below.
ACT: Do you think decentralized data collection tools such as eConsent and electronic patient-reported outcomes (ePRO) increase patient-centricity, or do you think they add complexity and burden? Why?
Galea: Well, I think having the ability to capture electronic data is obviously important and beneficial. I think there are two hurdles to overcome. The first is the user experience of these applications. As consumers living in a digital world, I think there are certain hurdles we expect when interacting with technology. From a B2C consumer perspective, that hurdle needs to be held within B2B, healthcare, or records collection. , or eCOA (electronic clinical outcome assessment), ePRO, etc. The expectation is to see the same level of integrity, user experience, speed, and feedback interacting with the applications that should be there as Apple’s research. First of all, these technologies need to have a certain level of ease of use. Next, we’re collecting data from the backend, and there’s still no industry standard on how to collect all this. On the healthcare side, like Medicare, about a decade ago the government created the FHIR (Fast Healthcare Interoperability Resources) standard for how data interoperability works. This is great from an EHR (electronic health record) medical record perspective, but there is a lot of work going on on the backend because in the life sciences field, we don’t necessarily have a medical record that everyone can harmonize with right now. Masu. Use my data format, include not only syntax but also semantics, make sure the semantics match your format and semantic structure, then harmonize it and present it as a unified dataset See what you can do. From the patient’s perspective, I make sure that it’s something I want to use and that it’s not a hurdle and there’s no barrier to entering data in a qualitative way. And on the back end, the question is whether the data exists or not. Do we need to bring it together so that it can be measured quickly and efficiently so that data harmonization collections don’t become the blank spaces between clinical life science milestones?
