Virtual Clinical Trials: Insights from a Podcast Episode with Daniel Piekarz

In DataArt’s recent podcast, Daniel Piekarz, SVP, Leader of Healthcare & Life Sciences Practice, discusses the impact of COVID-19 on the clinical trial ecosystem, shift to decentralized trials and use of AI in patient retention.
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By Daniel Piekarz
Sr. Vice President, Healthcare & Life Sciences, USA
Virtual Clinical Trials: Insights from a Podcast Episode with Daniel Piekarz

The podcast episode was transcribed below. Find the full episode, «Virtual Clinical Trials» on SoundCloud by following the banner below.

«Virtual Clinical Trials»
Listen to the Podcast Episode

Varvara Bogdanova: Today we’re happy to welcome Daniel Piekarz, Senior Vice President of Healthcare and Life Sciences here at DataArt. In this episode, Dan is going to tell us more about virtual clinical trials and how they have developed due to the COVID-19 pandemic. Hi, Dan! Thank you for coming. How are you?

Dan Piekarz: Good, how are you, Varvara?

V.B.: I’m fine, thank you. I have prepared a couple of questions for you. In your article on the impact of COVID-19 on clinical trials, you say that the pandemic has negatively influenced the clinical trial ecosystem. In what way exactly has it been affected?

D.P.: So, when COVID-19 came out and was affecting the United States and the world in general, different countries started coming up with the lockdown rules, i.e. stay-at-home or social distancing. This basically stopped the ability of patients to visit investigator sites where everything actually happens. In the United States and other nations, the regulatory bodies came out with guidance around how the sponsors and the investigators can continue to handle clinical trials under these stay-at-home rules. It accelerated the use of technology to solve a lot of the problems of not being able to see the patient directly. That was the main impact here. There is also some impact over the likelihood of a person becoming infected with COVID-19. This is impacting clinical trials because, as you go through a clinical trial, you are trying to understand the clinical outcome of providing a patient with a medical device or a drug. If a patient gets ill with something like COVID-19, that can throw off the results of the trial for that patient. Those were the different ways that the ecosystem was impacted, and luckily we have advanced technology pretty far to the point where today you have telehealth, you have remote patient monitoring and things like eCOA (Electronic Clinical Outcome Assessment), ePRO (Electronic Patient Recorded Outcomes). You have all these technologies to choose from to help offset the issues we had with COVID-19.

V.B.: I see. So, the pandemic has sped up the move towards those virtual clinical trials, hasn’t it?

D.P.: In the United States, the guidance from FDA was that the sponsors running the trials should use these technologies during the pandemic. This sped up the adoption of the use of these technologies. While I believe that this will continue to accelerate the use of these technologies, at this point we don’t know what the future guidance of the regulatory bodies will be. But I think everyone in the industry is hoping that this accelerates the use of these technologies and in turn improves the ability to collect self-monitoring data and understand safety monitoring data through the trial and have richer data sets than we would have had before. But we have to wait and see what happens with the regulatory guidance once the pandemic has passed us.

V.B.: These regulatory issues are a real challenge here to adopt these technologies.

D.P.: Yes. Let me explain it to you this way: all the trials that have been running were collecting information by directly interacting with the patient. Everyone is worried about the fact that those trials have now moved to remote monitoring, televisits, phone visits, and the change in the way they are collecting data because there is fear that that change in the collection of data from in-person to virtual could potentially impact the quality of the data overall. Then, when they are finally ready to submit the results of the study to the regulatory bodies, there could be problems found in that. That is the biggest fear because nobody wants any of these clinical trials, especially a clinical trial that is providing a drug that can potentially help millions of people. Nobody wants to slow that down. A change in the middle of the studies is always very risky.

V.B.: Do you think there is a way to overcome those fears? I mean to overcome the problem and the risk of the data not being reliable.

D.P.: I think the first point of ensuring that we can overcome that fear, and that we not only overcome the fear but actually collect equally valid data falls on the investigators. One of the things from what I have seen is slowing the adoption of some of these technologies. The primary investigator is the one responsible for the health of that patient. And if that investigator does not think that providing these services through a televisit platform and self-monitoring are going to be appropriately safe compared to monitoring in the investigator site, then they have an obligation to bring that up and choose a different route. Right now a lot of it comes down to whether or not the investigators are comfortable delivering the trials in this fashion.

V.B.: How can technologies help here, and what kind of technologies can help?

D.P.: A lot of people want to get really creative with these whole new systems, but, to be honest, things as simple as a phone call can replace some visits. Beyond the phone call, when you have to actually see the patient, then it is telehealth visits using things like Zoom that are HIPAA compliant. That can replace a lot of the visits. Anytime when you have to actually physically see the patient, then you move on to remote patient monitoring. This is where you have a mix of a mobile app with a wearable or other medical devices in the home that the patient uses to track their daily clinical outcomes. It could be a lot of different things depending on the trial. There is also eCOA. These things have been used for years, but at different levels of penetration. eCOA is basically a survey for a patient that is regularly sent out, asking how they feel, how they are responding to what is happening in the trial. Or patient diaries, or ePRO, which are, again, a sort of like patient diaries with very specific questions, and the questions have to be worded in a very specific way. These are the typical technologies that you are seeing being implemented. But we have a lot of innovation happening in the marketplace. People are looking at ways to leverage artificial intelligence for clinical trials. There is a lot of new things coming out, but because the clinical trial industry is so risk-averse, they are going to the more tried and true things first, and the innovation that is more cutting edge will come later.

V.B.: What about AI? You mentioned AI for clinical trials. How can it help and where can it be applied?

D.P.: There is a number of ways it could be applied. It is artificial intelligence, so it can look at data and come up with insights on that data. A good example of an area where I think AI could be applied is in patient retention. You could have a system that is trained to identify high-risk patients. When I say «high-risk», I am talking about patients that are likely to leave the trial or are likely not to follow the protocol. The system is trained to highlight them, so that the investigator site can interact with those patients more and keep them engaged in the trial. It can be things as simple as that. There is also a company out there called AiCure which uses artificial intelligence as a way to handle medication adherence. They apply AI to the video feed from your cellphone to ensure you are actually taking your medicine. There is a lot of different ways you can apply AI. For any problem that people run into in the clinical trial realm, there is probably a way we could apply AI to improve our understanding of that problem and the data that surrounds it. It is just a matter of us getting creative with what we want to solve, and then spending the time to train up a model that can actually assess that information and come back to us with intelligent insights.

V.B.: What about the technologies that are currently used for virtual clinical trials and that are being developed? Will they stay after the situation with the pandemic is over, or will we come back to traditional clinical trials?

D.P.:If I bring out my crystal ball and try to predict what will happen... I think we are going to end up with what people call decentralized trials. A decentralized trial is kind of a new word for what we used to call «hybrid trials.» This means that as we move forward, COVID-19 is not going to just disappear overnight; we are probably not going to be back to normal until we have a vaccine, and a good number of people inoculated with it. That is probably the reality, and between now and when that happens, what we are going to see is people using a mix of change of process, change of services, and change of technology. For instance, the biggest issue right now is patients visiting sites. To protect the patients’ safety, we have to make it so that we can bring the services to the patients somehow. Some of the services, for instance daily IV injections, can be brought to the patient with the technologies I have already spoken about. The patients are either going to need to go to the site, or the site is going to need to contract with in-home nursing care, or daily visits from the nurses to the patient’s house to provide those kinds of services. I think what we are going to see in the future is clinical trials’ shift to only having patients come to the investigator site when it’s necessary and have remote nurses visit patients when it is not necessary for them to come to the site, but somebody needs to be in the same room as the patient. Everything else will be happening through remote patient monitoring, telehealth and phone calls. It is going to simply change how clinical trials are run, but it is not going to happen overnight. Some trials are going to be considered riskier than others, and they will require patients to come to the site every single visit. You have to understand that there are trials that happen where the patients stay at the site for a month. There are other trials that happen for years and years, and the patient only visits once a month or sometimes even less, every 6 months. It all depends on the need in that given trial. But I do think there is going to be a definite change to how we operate when it comes to clinical trials moving forward.

V.B.: I have a couple more questions that our listeners are interested in. With such innovations coming into clinical trials, how do you see the change of CRO landscape?

D.P.: We have seen CROs change over the years. Years ago, a CRO was simply a services company that managed the day-to-day service for the sponsors. They have shifted to also managing aspects of the technology, and then some of them shifted to having and creating technologies of their own that they sell into the clinical trials. You actually see some companies coming out now that are focused on delivering decentralized clinical trials. I think the way it is going to change for CROs in the future is that they are going to have to provide the services and the technology or at least be technology agnostic and have partnerships with the companies that provide these technologies, so that they can basically operate the decentralized trial and make it easy for the sites, the sponsor, and the patients. There is definitely a lot of pressure that will be put on the CROs to be able to make this happen and to make that switch quickly.

V.B.: What would you advise them to kind of make that switch quicker and adopt such technologies, and what can play a greater role there?

D.P.: The issue with technology and some of these switches is whether or not the investigator is comfortable delivering healthcare-related services to the patient over those technologies and whether or not the change in how we collect data will impact the data itself. If this is a trial that has been running for years, will that shift from in-person data to remote data cause an anomaly in the data that would cause a problem with the trial in the long term? I think those are the problems that we have to get around, and I think that a lot of it just takes a bit of due diligence, a bit of training when it comes to the investigator sites, the investigators and the CRCs. There is also going to have to be a shift in how CROs monitor those sites. They have to go one step at a time, and, because the industry is so risk-averse, everything has to be double-checked. Unfortunately, I don’t think there is a simple answer here. We have to make a lot of changes to the industry in a short time, and we have to do it right.

V.B.: Thank you for coming today and giving us an interesting talk about virtual clinical trials and their future.

D.P.: No problem at all, it was good talking to you, Varvara.

V.B.: Hope to see you again, thank you!

D.P.: Bye, have a great day.

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