Todd Pruzan, HBR
Welcome to the HBR Video Quick Take. I’m Todd Pruzan, senior editor for Research and Special Projects at Harvard Business Review. A decentralized clinical trial, or DCT, is a method of conducting clinical trials in which part or all of the trial happens outside a traditional physical clinic or trial site.
This removes barriers to participation, enabling more patients to participate in research. And it enhances the overall trial experience for everyone. Anthony Costello is CEO of Patient Cloud at Dassault Systemes.
In this role, he leads the development of Medidata’s patient-facing activities and solutions, including decentralized trials, technology, and strategy, and Patient Cloud, Dassault Systemes Product Apps, MyMedidata Patient Portal, Disease Registries and Recruitment, Telehealth and Virtual Visits, and Sensor Cloud and Biomarker Discovery. He’s here today to talk to us about the rising adoption rate of DCTs and how these solutions affect research. Anthony, thank you for joining us.
Anthony Costello, Medidata
Thanks so much for having me, Todd.
Todd Pruzan, HBR
Anthony, what do decentralized trials and the use of new technology mean for patients, for pharmaceutical companies, for doctors?
Anthony Costello, Medidata
We’re in such an interesting time in the history of clinical trials and research. If you think about the way trials have been done traditionally, they’re very heavily centralized, meaning patients travel to a research center, often many times per month for months and months during a clinical trial. So what we mean when we say trials are now being decentralized is that the research is moving outside these central research sites and more into the patients’ real lives.
And the reason this is so important for the industry is if you think about the way research gets done and then new drugs get commercialized into the market, patients use these products in their real lives, in the real world, obviously, not in a method that’s centralized around a research center, but in their day-to-day lives. So we’re trying to move the industry and the research part of discovery into the real world where these drugs will actually be used after they’re commercialized.
So it’s a critical moment for the way research gets done, the pace of research, the ease of research for patients, the quality and quantity of data that we’re capturing—all things that are much easier to get or to achieve in a decentralized model.
Todd Pruzan, HBR
OK, so pharmaceutical companies, what do they need to be thinking about when they’re considering a DCT model for research?
Anthony Costello, Medidata
This has been the real challenge for our industry. We have a conservative pharmaceutical research industry very largely based on regulation, paper processes, paper data capture, paper consent signatures, and so on. And a lot of what we’ve done over the past few years, as an industry, is we’ve begun to embrace and leverage the natural curves in the world of technology.
Patients have more technology in their hands. They’re more accustomed to using it. They’re more trusting of providing information and receiving information through digital devices. Most patients carry some device with them in their pocket all day every day that’s perfectly suitable for research.
So the kind of hump to get over has been, will pharma decide to use these capabilities and this—let’s call it this new digital era—as a way to conduct the research that maybe we formerly would have done on paper or through a much more cumbersome process? So you take the idea that we want to decentralize outside of a site setting, then you add in that we have the technology. The patients have the technology. They’re comfortable with it. We can scale it. It’s affordable—all of these things that you couldn’t say 10 years ago or maybe even five years ago in some cases.
You start to layer in things like wearable sensors that are getting easier to use, better battery lives, smarter, faster, better-quality data. You put it all together. And we’re in this perfect storm in the industry right now to hyper-accelerate research across all different types of disease indications.
We saw a little bit of this during COVID. Maybe I’ll call it kind of a foreshadowing of where our whole industry tries to go now. Because of a global pandemic, there was a lot of kind of consolidation around “let’s do this faster.” Let’s have more outreach to patients. Let’s decentralize.
Now you’re seeing that become the new normal, the trend. And everyone’s looking for ways to kind of leverage this perfect storm, if you will, as a way to change the way all clinical trials work into the future. And if we do it right, what we’ll be doing is going from a world where we try to expose as few patients as possible to an experimental product, which, obviously, we always want to do that. But we want to expose the right patients.
We want to do it in a way that’s not too burdensome for them. And we want to make sure that when that drug gets approved and hits the market and millions of people take it, that we’ve done the research in as close a setting as we possibly can to the kind of real-world commercial setting where those people will use that product.
Todd Pruzan, HBR
That sounds great. So how does a patient participate in a DCT?
Anthony Costello, Medidata
Interestingly, I would say patients don’t get to choose DCTs as much as DCTs choose them. And it’s because if you’re a patient, you enroll in a study many times because you have no other health care option for your particular disease. And sadly, for many patients, the clinical research may be the last option that they have after trying everything else for whatever condition they have.
So a patient will choose a study out of necessity in a lot of cases. And hopefully, what we’re aspiring to support in this industry and what we’re working with our customers to try to achieve is more optionality for that patient on that study to be able to use these technologies in their real-world setting.
Patient burden is a huge problem. In our industry, sticking on these trials for a year, a year and a half, is burdensome. Going back and forth to study centers all the time is very burdensome. We lose a lot of patients.
And frankly, we have a lot of patients who qualify for the study. They need the study. They have the right set of criteria, inclusion criteria, for that study, but they simply can’t participate due to lack of geographical proximity to some study center that’s running that trial.
So decentralization—if you’re a patient on a study that happens to be decentralized, you’re much more likely to stay with that study throughout, to be able to participate in that study regardless of where you live, and then, as I said earlier, to be able to provide real-world data from your day-to-day activities that are critical to the pharmaceutical company really understanding how their drug is going to work when it hits markets.
So it’s a hard choice to make for our customers. It is a challenge to decentralize a clinical program that you have formerly run entirely at research centers. But if you do it, there’s a huge upside, both for patients and for the speed and accuracy of the research. And we’re expecting that both of those things are going to cause a forever trend of decentralization and in clinical trials.
Todd Pruzan, HBR
That’s great. It sounds like a very promising set of developments. Anthony, thank you so much for being with us today. This is fascinating.
Anthony Costello, Medidata
Thanks again for having me. It’s been fun, and I appreciate it.
Learn more about Medidata and decentralized clinical trials.
