Ensuring Patient Engagement and Data Integrity in Trials

In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed the challenges in the clinical trial industry, emphasizing low awareness among both patients and providers. He highlighted operational issues, including the difficulty in identifying and engaging patients, data interoperability, and ensuring data quality. Galea stressed the importance of user experience in electronic data capture tools and the need for industry standards. Prioritizing data collection should focus on safety, efficacy, and efficiency, ensuring data quality, and avoiding workflow disruptions.

A transcript of Galea’s conversation with ACT can be found below.

ACT: What are some ways sponsors should be empowering their patients to ensure they are returning quality data?

Galea: I mean, obviously we need to, first and foremost, ensure that the firewall between the sponsor and the individual is there and upheld. There's a lot that the sponsors can do to ensure that the engagement on the patient side is going to be there, making sure that there's a call for comprehensive education and training, that the information on how to use these tools and capabilities is clear and that the education material and the certification process is not just relevant, but seamlessly and quickly done. We talked about the expected experiences in the B2C space to make sure that these collection tools are user friendly, that the data has integrity, that it has the right type of checks in place, so that we collect qualitative data, that there's regular communication and support between the individual, the tool, and whoever's overseeing the data collection, so that if I have a question, I could get immediate answers, whether that's through reference materials, through simplistic AI, or other things. I could go on, but I'll focus on those top three to four items.