In the latest episode of Impetus Digital‘s Fireside Chat, I sat down with Munther Baara, VP Product Strategy and Innovation at EDETEK, and discussed all things clinical trials. Among other things, we discussed the current gaps and the impact of COVID-19 on the way Pharma approaches clinical trials. We also dived into data lakes, digital technologies for making clinical trials more seamless, and much more.
Here is a sneak peek of our conversation:
Q: What sorts of levels of resistance, aversion to change, or objections have come up in this transition to moving towards more resilient [clinical trial] endpoints or changing the methodologies, trial protocols, and data collection?
A: This is an interesting question. I think if it wasn’t for a COVID, my answer would be slightly different than what I’m going to give you right now. People had to work from home, people cannot interact with each other, people are dying, so now, the need is completely different. It came directly from the top-down management to say, “We have to start the studies, it has to go super fast.” That basically was the driver and the other pain points, which actually COVID exposed in other studies such as, “How do you ship medicine?”, or, with the studies you are currently conducting, “How would the patients get the medicine if they cannot go to the site?”
People with chronic diseases are afraid of the coronavirus. They are not gonna go to the site, so how are you going to get the medicine to them? That is kind of introducing a new variable into the formula and now the COVID studies need to happen fast, as well. With that, and the mundane that came from the top-down that we need to go fast, a lot of things run in parallel rather than compromising the processes and the quality. I don’t think anybody compromised in that; they’ve done a lot of things in parallel and proactively.
In my experience, if you go talk to any of the sponsors, their systems are optimized for internal use. The external interaction is not optimized for that. With the new modalities that would get added, the telemedicine and what have you, those are hard. I feel like a lot of people, it was based on heroic efforts from individuals within each of those companies, in order to save people’s lives and they work so hard for hours and hours. I call it “duct-taping” data together in order to make sense out of the speed. Then they start working on solutions to see data on a real-time basis.
One of the things that we’ve done in our system was refreshing data almost six times daily for one large study. That’s huge and unheard of, because typically people are waiting for a week or two to look at data, but here, they are looking at the data in real-time and multiple times to make decisions basically…
For more of our discussion, you can watch the whole Fireside Chat with Munther Baara, or listen to the podcast version, below.
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