SCOPE Europe 2023: Regulators on eCOA and DHTs


In an interview at SCOPE Europe 2023 with Applied Clinical Trials Editor, Andy Studna, Tony Mikulaschek, VP, eCOA, IQVIA Technologies discusses how regulatory bodies are currently viewing the data collection space.

Mikulaschek: A couple things with that one. About 11 years ago there was some guidance provided by FDA and that was kind of generic guidance and right now what we're seeing is that there's four draft guidances out from FDA, they're not finalized with the draft and they're really good draft guidances on what kind of information should be collected, how it should be collected, and things to be thinking about. I don't know when it's going to turn into regulation, hopefully sometime next year; FDA is working through that. I know last year they solicited feedback, but there’s four draft guidances. So those are really helpful to the industry right now and I think what we're seeing from a COA standpoint and the technologies that COA utilized is a greater acceptance and a greater need for that information the FDA is very interested like I'd said in capturing the voice of the patient. To make that data as a part of the clinical submission, so having the rules and the regulations to collect that data is very important, I think they realize that. It’s good guidance, hopefully it becomes final guidance next year or portions of it will. I think COVID is another thing that helps spur some of that because it helped push BYOD and utilization of bring your own device technologies and continued to not necessarily enhance, but define how DCTs can be utilized so there's a lot of good information in that guidance that people should be following and or looking to follow when it becomes regulation.

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