Transcription: Virtualizing Clinical Trial Recruitment for Speed and Massive Scale



Greg Kefer: (00:08)
Welcome to Digital Conversations. I'm Greg Kefer and I'm joined today by Justin Mardjuki. Justin, good to have you back.

Justin Mardjuki: (00:15)
Thanks Greg. Good to be back.

Greg Kefer: (00:16)
Yeah, we're virtual, still doing our podcast show from our home office and we're going to focus on a topic that's actually been in the mainstream news quite a bit, and that is clinical trials. And if you go to any mainstream news outlet in the era of COVID and the search for a vaccine, I think more general consumers know about clinical trials right now than ever before. Wouldn't you think?

Justin Mardjuki: (00:42)
That's right. It's on the front pages everywhere.

Greg Kefer: (00:44)
Yeah. And fortunately, some very promising stuff in the pipeline, but you know, clinical trials actually go well, well, beyond the need to get a vaccine for COVID. I mean, clinical trials are part of the development cycle for any drug that's made ever. And that is a process that isn't something that normally goes through in less than a year, right?

Justin Mardjuki: (01:06)
That's right. Between getting an IRB protocol approved recruiting patients, administering the trial, you can be looking at several years for a later stage, large volume trial.

Greg Kefer: (01:16)
Right. And that process historically has been somewhat of a slow cumbersome manual process to get those done. Is that correct?

Justin Mardjuki: (01:26)
That's right. The challenge has always been between sponsors, often manufacturers sponsoring the trials, the clinical research organizations orchestrating the trials, and the sites that are administering the trials and accepting participants into the trial. There's a lot of technology processes, workflows, that are siloed within each of those organizations. And because trials only occur over a finite amount of time, that experience or the technology pulled together can be wildly different from trial to trial.

Greg Kefer: (01:55)
Right. In many ways there's a dimension of getting patients to a physician, for example, as one of the big hurdles as part of that process, is that true as well?

Justin Mardjuki: (02:06)
Yeah. So the scheduling moment in a clinical trial at the top of the funnel where you've had a patient screen in, complete a pre-screener, they're eligible for the trial, and you need to get them to their first office visit. That could be in a remote trial, a virtual visit, or it could be an in-person visit at a trial site. That scheduling moment is one of the largest drop-offs in a clinical trial. 30% of all trial timelines are caused by recruitment. And a lot of sites struggles to even enroll one patient. 50% of sites never enroll a single patient. So getting that moment right, and making it easy for patients to refer to a site and schedule that first visit is really key.

Greg Kefer: (02:47)
Right. And, it's not to say they don't have technology, but I think one of the challenges has been the dimension of outreach and connecting with patients, patient engagement. We like to talk about engagement here on Digital Conversations, in terms of how do you contact that person? How do you help them get to that appointment at the right time at the right place? And that's a lot of phone calling, correct?

Justin Mardjuki: (03:11)
Traditionally it's the patient access agents or the front desk staff at those sites that are responsible for seeing that a patient has been referred to their site, calling the patient back, scheduling them for a visit. But that process can take several phone calls, several missed calls, and by the time they've actually connected with that patient, they might no longer be interested in participating in that trial. So, the current way is very manual and disjointed. And if you're the CRO or the sponsor of the study, you're looking at this through a very smoky lens. You have no idea exactly how the sites are performing. So it's a complex problem, one that sounds easy -- scheduling patients for their first visit, but with so many players in the mix, it's incredible how much of the process breaks down because of poor communication or the inability to reach patients.

Greg Kefer: (03:58)
Now, as technology has matured., you know, everybody's got a mobile phone, so that's one opportunity area. It's probably less about building and deploying new apps because there are simply too many apps for patients to consume. We've talked about that on this show before. We've talked about conversational technology and chatbots, and we've actually talked about it in the context of a hospital, where a conversational digital agent using interactive conversational workflows can get people scheduled for a physical, or a visit to the dermatologist. A lot of that same capability is now able to be applied into the trial dimension of healthcare to get people to those appointments. Can you talk a little bit about how some of that stuff is working out and some of the stuff you've been involved with?

Justin Mardjuki: (04:48)
Sure. The first thing to say maybe is that a chatbot or a digital assistant is a very easy, intuitive way for patients to interact or participants to interact with what might otherwise be a complex system. They can do it on their own time. They can do it when it's convenient for them. It will always meet them at the appropriate literacy level or language (if the trial is being held in multiple countries). And that chatbot front end is really just the tip of the iceberg of what needs to fall in place to schedule a patient. So, data about that participant can live in multiple systems. It can live in a recruitment system where the patient has completed their screening and eligibility. And the scheduling information is held by the clinic system, oftentimes an EMR system, or a CRM, or a scheduling system. So, a digital assistant that is addressing the trial scheduling moment has to be able to integrate with these various systems of record with disparate owners and be able to guide the patient smoothly from one end of that workflow, to the other. And potentially that can be one conversation or multiple conversations over days, weeks, months.

Greg Kefer: (05:54)
Right. So when you're talking about conversations, the chatbot is literally talking to a person in chat bubbles and explaining things in very common ways. And of course, when you're about to enter a trial, you might have lots of questions, right? I mean, you may wonder, do I really want to get injected with this thing that could kill me or make my arm fall off? Right? So there's probably a lot of apprehension that people have, and getting it from a conversational bot can obviously lower that anxiety, and maybe get more honest responses from people because they're not actually speaking to a person. Is that a dimension that comes into play as part of this?

Justin Mardjuki: (06:32)
That's right. If you look at a lot of consent or education or awareness flows around a clinical trial, there's often information or literature on a website, which patients can read on their own time, or they're relying on clinical research associates that are reading from scripts that were approved by the IRB. And if someone is reading off a script to you, human nature is not to take up more of their time. It's to get to the other end of that phone call. So it's no surprise that in polls of patients that dropped out of trials before they were able to schedule that first office visit, 40% of them said they were unwilling to enroll because they didn't actually understand what was going to be asked of them, or required of them, in the study. So to equip them with a tool, a digital assistant that can be with them every step of the way from awareness pre-screening eligibility, through scheduling, through a consistent, easy to use experience is night and day between that and getting juggled between three different clinical research associates, all working in different time zones.

Greg Kefer: (07:31)
Right, right. If you've ever read those clinical papers, those PDFs, they're not exactly the warm and fuzzy kinds of things that are going to make you feel really excited about being part of the trial as a potential patient. Right? So the other thing that we definitely touched on is just the dimension of scale. I mean, again, this COVID vaccine chase that's underway obviously puts an immense amount of pressure to go big and go fast. And of course, once again, if you've got armies of people, reading scripts, dialing for patients that still takes a lot of time. And I would think that, you know, this ability to kind of exponentially scale the scope and outreach through digital assistant could really compress timelines.

Justin Mardjuki: (08:13)
That's right, automating these care coordination, scripted workflows can have a huge impact on the staffing or the training time that it takes to get trial recruitment up and running. And one of the subtle benefits here is while currently only a small percentage of trials are fully decentralized virtual trials, a majority are still centralized in person trials, putting a digital assistant wrapper around that front end experience of getting into a centralized in-person trial can give it some of that scale, dimension, and reach of a virtual trial. So being smart about where to pick your spots, where to automate workflow, where it's already scripted, defined, and high value to automate, we feel that, at Lifelink Systems, scheduling is one of these perfect opportunities to automate with digital assistants.

Greg Kefer: (08:59)
Yeah, sure. Here's another dimension that I would think could be really interesting. I'm sure that there's a lot of data, a lot of intelligence that's gleaned from all of the systems that are in place helping these trials. But you know, you add in this conversational layer into that mix and you capture all of the touchpoints, all of the pathways, all of the responses,...there's probably a lot of really interesting business intelligence at a behavior level that you can use to even get smarter as you move through these trials. Is that part of this mix too?

Justin Mardjuki: (09:32)
That's right. Once you've automated a high volume workflow like this and you have enough data -- micro data -- about...chatbot said, participant said, chatbot said, participant said,...you can see exactly where participants are getting hung up or confused or dropping out of the funnel. When you have enough of that data, you start unearthing these opportunities to optimize those automated flows. So you can get percentage improvements in scheduling conversion by running many, many A/B tests. And that's exactly the type of work that Lifelink Systems does across our customers. And once you're there, there are all kinds of opportunities to then dive into the data, to look at conversion by patient population or scheduling by distance to sites, all informed by this new form of conversational engagement data that you never had, before participants scheduled.

Greg Kefer: (10:22)
Okay. So final question: COVID is forcing these trials to pick up speed, go much larger than maybe the average trial, because it involves the world. Do you think that this is an inflection point in the way trials are done that, you know, when the pandemic is in the rear view mirror and we've got a cure and we're telling our friends about it decades from now, is this the way trials are going to be conducted in the future? Do you think that this is the straw that broke the camel's back in terms of getting out of the old ways and into a new, smarter modality?

Justin Mardjuki: (10:55)
Yeah, I think COVID, and the scale of these trials has accelerated the process towards digitization, automation, and virtualization by a decade. There was always the promise of patient reported outcomes, and real-world evidence collected in "phase five trials" after your traditional trials were done, but sponsors and CROs have never had to deal with this level of increase in volume an order of magnitude larger in volume with half the time. And I think some of these changes will be here to stay once we start seeing what the value opportunity is between cost savings, FTE reductions, and just how much better of a participant experience it is.

Greg Kefer: (11:37)
Yeah, for sure. And there's another part of this whole equation, which we'll have to cover in our next podcast, which is trial execution, you know, the whole PRO dimension and the execution of the trial. Once they're in the trial, once they've been enrolled, once they've started, keep them on plan. That sounds like a ripe, conversational agent opportunity.

Justin Mardjuki: (11:58)
That's right. Imagine you've done all of the hard work to get a patient scheduled into a trial. And rather than fully let the sites determine the engagement with the patient -- sometimes they're reaching out, sometimes they're not -- CROs, sponsors, and other organizations can start bringing in some of this technology to follow patients throughout the entire journey to make sure that they're staying on protocol and identify times when they might be deviating from it.

Greg Kefer: (12:22)
Right. Yep. Okay. Well, I suspect we will be hearing and seeing more about this as we move through this interesting time. Justin, it's been a pleasure having you on the show again. We'll have to have you back again soon. Thanks. This has been Digital Conversations. Thanks for listening to Digital Conversations. If you liked our show, you can always subscribe on iTunes and feel free to like retweet and share on your social networks. This and other episodes are available on iTunes, Spotify and Linkedin.com. We'll be conversing again soon with a new episode. So long.