Todd Pruzan, HBR
Welcome to HBR Video Quick Take. I’m Todd Pruzan, senior editor for Research and Special Projects at the Harvard Business Review. A decentralized clinical trial, or DCT, is a method of conducting clinical trials in which part or all of the trial takes place outside of a traditional physical clinic or trial site.
It removes barriers to participation, enabling more patients to participate in research. And it improves the overall testing experience for everyone. Anthony Costello is the CEO of Patient Cloud at Dassault Systemes.
In this role, he led the development of Medidata’s patient-facing activities and solutions, including decentralized testing, technology, and strategy, and Patient Cloud, Dassault Systemes Product Apps, MyMedidata Patient Portal, Registry and Disease Recruitment, Telehealth and Virtual Visits, and Sensor Cloud and Biomarker Discovery. He is here today to talk to us about the increasing adoption rate of DCTs and how these solutions impact research. Anthony, thanks for joining us.
Anthony Costello, Medidata
Thanks so much for having me, Todd.
Todd Pruzan, HBR
Anthony, what does decentralized testing and use of new technology mean for patients, for pharmaceutical companies, for doctors?
Anthony Costello, Medidata
We are at an interesting time in the history of clinical trials and research. If you think about the way trials are done traditionally, they are highly centralized, meaning patients travel to a research center, often multiple times per month for months and months during a clinical trial. test. So what we mean when we say that trials are now decentralized is that research is moving outside of central research areas and further into the real lives of patients.
And the reason it’s so important for the industry is if you think about the way that the research is done and then the new drugs are commercialized on the market, patients use these products in their real lives, actually world, obviously, not in a method. which is centralized around a research center, but in their daily life. So we’re trying to move the industry and the discovery research side into the real world where these drugs actually work after they’re marketed.
So it’s a critical moment for the way research is done, the pace of research, the ease of research for patients, the quality and quantity of data that we’re getting—all things that are easier to get or get. -ot in a decentralized. model.
Todd Pruzan, HBR
OK, so pharmaceutical companies, what should they think about when they consider a DCT model for research?
Anthony Costello, Medidata
This is the real challenge in our industry. We have a conservative pharmaceutical research industry that is largely based on regulation, paper processes, paper data capture, paper consent signatures, etc. And a lot of what we’ve done in the last few years, as an industry, we’ve started to embrace and use the natural curves of the technology world.
Patients have more technology at their fingertips. They are more used to using it. They are more confident in giving information and receiving information through digital devices. Most patients carry a device in their pocket all day every day that is perfectly suited for research.
So the kind of hump to overcome, will pharma decide to use these capabilities and this – let’s call it the new digital era – as a way to conduct research that maybe we could have done before on paper or by many more. difficult process? So you take the idea that we want to decentralize outside of a site setting, then you add that we have the technology. Patients have technology. They are comfortable with it. We can measure it. It’s cheap—all these things that you couldn’t say 10 years ago or maybe five years ago in some cases.
You start layering things like wearable sensors that are easier to use, better battery life, smarter, faster, better quality data. You put everything together. And we’re in this perfect storm in the industry right now to facilitate research into all different types of disease markers.
We saw a bit of this during the COVID era. I would probably call it a foreshadowing of where our entire industry is striving right now. Because of a global pandemic, there is a lot of consolidation around “let’s do it faster.” We have more outreach to patients. We will decentralize.
Now you see it become the new normal, the trend. And everyone is looking for ways to use this perfect storm, if you will, as a way to change the way all clinical trials are going forward. And if we do it right, what we do is from a world where we try to expose as few patients as possible to an experimental product, which, obviously, we want to do that. But we want to expose the right patients.
We want to do it in a way that is not too burdensome for them. And we want to make sure that when that drug is approved and it hits the market and millions of people take it, that we do the research in as close a setting as we can to the kind of real-world commercial setting. where people will use that product.
Todd Pruzan, HBR
That’s great. So how does a patient participate in a DCT?
Anthony Costello, Medidata
Interestingly, I would say that patients do not choose DCTs as much as DCTs choose them. And this is because when you are a patient, you enroll in a study many times because you have no other health care options for your particular disease. And unfortunately, for many patients, clinical research may be the last option they have after trying everything else for whatever condition they have.
So a patient chooses a study because of the need in many cases. And hopefully, what we aspire to support in this industry and what we are working with our customers to try to achieve is more options for the patient in that study to use these technologies their situation in the real world.
Patient burden is a huge problem. In our industry, keeping these tests for a year, a year and a half, is heavy. Going back and forth to study centers all the time is very heavy. We lost many patients.
And actually, we have a lot of patients who are eligible for the study. They need to study. They have the right set of criteria, inclusion criteria, for that study, but they can’t participate because of the lack of geographical proximity to some study centers that run that trial.
So the decentralization—if you’re a patient in a study that happens to be decentralized, you’re more likely to stay in that study throughout, to be able to participate in that study wherever you live, and then, as I said earlier, to provide real-world data from your day-to-day activities that are critical to the pharmaceutical company that truly understands how their drug performs when it hits the markets.
That’s why it’s hard to choose for our customers. It is a challenge to decentralize a clinical program that you previously ran in research centers. But if you do this, there will be a huge increase, both for the patients and for the speed and accuracy of the research. And we expect that both of these factors will lead to an endless trend of decentralization and clinical trials.
Todd Pruzan, HBR
That’s great. This seems to be a very good set of developments. Anthony, thank you so much for joining us today. This is interesting.
Anthony Costello, Medidata
Thanks again for having me. It was fun, and I appreciate it.
Learn more about Medidata and decentralized clinical trials.
