Determining the Effectiveness of Decentralization Across Different Trials

In a recent video interview with Applied Clinical Trials, Cameron Breze, product manager, Inovalon, discussed challenges in patient recruitment for clinical trials. Traditional recruitment methods, such as manual outreach, are now less efficient due to accessibility issues. Breze highlighted technology as a way to address recruitment challenges, which can be leveraged to automate and streamline processes, reducing labor intensity and errors.

ACT: Is the incorporation of decentralized elements and more remote trials helping with enrollment? Why or why not?

Breze: The efforts towards decentralized trials and remote patient recruitment are something that has been birthed out of recent changes in technology, but also socially and culturally, with the COVID 19 pandemic in 2019 to 2020, we really reframed, okay, how can we move research forward within particular constraints? I think it's always going to be a matter of what's the best fit. There are certain trials where that remote or decentralized approach might be best suited. You can think of, say, cream or an ointment for a skin condition where you could take a picture of it with your cell phone. There's no risk to your health in the long term. It's just something that might be visually disturbing you or affecting you mentally. Same thing with a lot of mental health conditions, where you could have therapy that's conducted remotely, or some cognitive behavioral combination of the two, plus an intervention. With that said, there are still trials that will essentially never be remote. There are a lot of more complex biologics that are being released on the market, where they're required to be administered through an IV or some other complex administration method where you have to be at a physical research site. It's not as simple as just taking a pill and then they'll monitor you and maintain that clinical connection as you move through the trial. I think it's something that people have in mind, and I think the most forward thinking organizations have a dual minded approach, where there will always be trials that are optimized for that decentralized approach, and then there are trials that will be better suited for powerhouse academic research centers and everything in the middle, because it will be quite a spectrum, and that will continue to evolve as we get new disease indications that are now accessible to treat. I'm very excited with a lot of the computational chemistry and computational biology methods that are coming out, where we can match, more specifically, to a lot of mild to moderate, genetically inspired disease and treat that through something like a biologic. All of that to say, that dual approach is what I think most organizations will take going forward, and it will continue to bear fruit, and we'll pivot and adapt as the industry moves along with us.