[MUSIC PLAYING]
HANNAH: Hello and welcome to the Totally Clinical Podcast brought to you by Teckro.
Totally Clinical is a deep dive into the freshest trends, big time challenges, and most excellent triumphs of clinical trials.
I'm Hannah, your host. Join me as I chat with industry experts, trailblazers, thought leaders, and most importantly, the people benefiting from clinical research.
So tune in, settle back, and don't touch that dial. It's time to get Totally Clinical.
[MUSIC PLAYING]
This week, I'm joined by Teckro's Maria Milas.
Maria is an expert in clinical research with years of experience working in clinical research associate positions for the likes of ICON and IQVIA.
She's here on the podcast to give us a glimpse into the life of a CRA. Maria discusses how technology is reshaping the patient CRA relationship, why she's happy to leave her hectic flying schedule behind post-pandemic, and her struggle remembering 180 pages of the protocol.
Welcome, Maria. So could you start by talking the audience through your typical day?
MARIA MILAS: As a CRA, let's say that we have two main different types of activities, different days, I would say. So it really depends if you are going to have a monitoring visit, which means you're going on site, or nowadays, let's say, if it's a remote monitoring visit. But let's say you're going on site. And then a different type of day of activity would be an office thing.
So let's go first to the office day, which, I would say, it's more boring and not so exciting. And then we go to a monitoring visit. So if I am not on a monitoring visit, I would probably check on my emails, see if there's anything urgent. Probably I would get around three to five phone calls from my sites in the different trials I'm working on, asking for you a doubt, support, or guidance how to proceed with whatever activities they're doing today.
I might also have a look at--
if I had any monitoring visits, I would be doing the reports. Or if the reports have already been reviewed by the clinical trial manager, I might have to do a second review, and then do some modifications or changes or maybe some extra information that is needed. So there's a lot of small activities that you have to do in order to keep control of the status at the site of the clinical trial. And that would be more or less an office day for us here, right?
HANNAH: And I imagine a typical day at a site would look very different.
MARIA MILAS: If I was going on to a site for a monitoring visit, I would probably start the day traveling. Maybe if I want to just go the same day, probably wake up really early, maybe 3:00, 4:00 AM, catch a flight really early, go to wherever your site is, maybe an hour and a half flight. And then I would probably reach the site, and then I will see who I'm to meet. Maybe I am meeting the PI in that day, or maybe I am meeting the study coordinator.
So yeah, starting from there, I would need to find usually a place where to monitor. There's sites who have a specific room, let's say, for the CRAs to do the monitoring and visit. There are sites who don't. So usually, you can be working in the investigator's office, or in any office that--
anywhere you can find a spot and put your laptop on a desk.
So that I would probably just spend my full day doing monitoring of the data, which means you would make sure that what's in the CRF, in the system, is accurate with what we have of the medical--
in the medical history records. So there's not only that, but I would say that's the main goal of a monitoring visit.
HANNAH: Sounds like a long day. What about some of the other tasks?
MARIA MILAS: You have all the trainings of the site staff, you have review of the ISF. You would be also going to the pharmacy for a visit, short visit--
probably one, two hours visit in that day--
and check on the stock of the drug, whatever drug you're using in the trial. And again, you also have to make sure that the site staff at the pharmacy is also trained with the most current versions of the documents in the clinical trial.
And then probably I would meet back with the investigator, or the study coordinator, at the end of the day, and we would discuss findings, or queries, or if there's anything that needs to be done. Further actions.
And then I would probably, if it's just a one day monitoring visit, I would take a train or a flight back home. Or if it's a two days, I would just stay overnight and do the same thing tomorrow.
HANNAH: So, I imagine much of that must have moved online now, due to COVID.
MARIA MILAS: Absolutely. So I would say that, when I started, I must have had maybe 20% of my sites doing remote monitoring, and this has changed to, I would say, 80%.
So that's a lot. It's a huge increase, which, for a CRA, means less traveling. Most of us will be happy with that, because we spend a lot on the road.
It means that we have more software to synchronize the medical history. You need really secure and compliant software to do that, which means that also CRAs now prefer monitoring from the comfort of your home. Because all the data that needs to be monitored now is much more trackable. You can track if a patient has taken the drug today, because some sites, some trials, even use sensors that tell you--
in a confidential and anonymous way, of course--
they tell you if the patient has taken the drug today or not, and you can follow up on that.
So as--
being a CRA, if you can track almost everything happening at a site in your trial, it gives you a lot of more confidence of having control, and also being able to spot risks or potential risks before they even happen.
HANNAH: Do you have any examples?
MARIA MILAS: A patient wasn't typed.
This patient was going to have some lab samples that day, but for some reason, the--
the lab nurse was using the incorrect kit.
So I was literally notified of that on my watch, so that was amazing. Like, I could see that on the spot, I could go down into my lab, to go into the report, see what was missing, which kit was incorrectly used, and call the nurse, and tell her, hey, this is what's missing. Please run the missing tests.
So that's--
for a CRA, having that accessibility to data in real time is crazy.
HANNAH: It just goes to show how fast things can change in the world of clinical research. Moving on from this, could you tell me about the biggest challenges you face in your role?
MARIA MILAS: One of the biggest challenge I have as a CRA is this feeling of responsibility. You are responsible of reviewing all the data in that clinical trial, and you can't miss a thing, let's say. I mean, you sometimes do miss something. We're all humans, right?
But the idea is that you don't miss a thing.
And at the same time, you can't know a protocol of maybe 180 pages by heart, so you're struggling between giving a response or a guidance at the time where the patient is still on site, and they need--
the investigator needs a response now. Between that--
you're struggling between that and also going back to the protocol, which is in a paper document, and trying to find the answer that you might not even know by heart.
So that responsibility of giving guidance when sometimes there's not--
nobody who you can go to, because maybe your sponsor is in a different time zone, or maybe your trial manager is not available, he's in a call or--
you need to take that decision, or this specific assessment, or whatever needs to be taken. The decision will not be taken right at the moment when it needs to be taken. So there's a feeling of responsibility, a huge feeling, when you are a CRA.
As a CRA, there's probably a lot of stress as a--
as a challenge. So it's this feeling that you have that, in any instant, at any point during the day, you can get a phone call from somebody on one of your sites and boom, there is a terrible issue that you need to solve, or an urgent thought that needs a response. And it has to be done now, but like, really right now. So as a CRA, I think you always need to be ready--
in a ready for sprint position.
HANNAH: In terms of the pandemic, you've touched already on how your role has changed. Could you expand on that a little?
MARIA MILAS: Let's say that before the pandemic, a CRA would more or less know what the day to day would be. You would know, more or less, what the timelines or the deadlines for your study, for the trial, are going to be. There were not many delays. I would say there were not many unexpected things that would happen.
But with the pandemic, as you can imagine, there's been a lot of delays in both recruitment, also in patient visits. So, because of the pandemic, many visits had been not only delayed, but also canceled. So that means that your activities as a CRA may also get on hold. So I would say that now, as a CRA, there's a lot more uncertainty.
Although, on the same page, I would say that there is more software, and there's more technology that has been implemented trying to compensate this need of having more control over the study. Which helps you as a CRA, of course, but there is still that feeling of something can happen at any point. And we need to adapt both the protocol, both the procedures of the trial. And you as a CRA, you have to adapt as well.
HANNAH: Could you explain a bit more about this, how you adapt?
MARIA MILAS: Instead of going to a site, where you're going to do a remote monitoring visit. Maybe, instead of doing a frequency of 8 to 12 weeks, you're going to do a monitoring visit every four weeks, trying to compensate that potential risk of not knowing what's happening at the site.
And same happens for the investigators. There's windows in the protocols for the patient visits. So, let's say that you are supposed to have a patient coming in next week, and you have a three days window. So there's a lot of uncertainty, because you don't even know if the site--
if the patient is going to be able to make it to the site.
I would say this has changed a lot in the CRA role. You need to be a lot more adapting to the new circumstances, and of course you learn new vendors, new technologies, new supports, new infrastructure that nowadays we have, and we didn't used to have.
HANNAH: There's been a lot of talk about the inevitability of decentralized trials. What do you think about this, and how do you see your role changing in the future?
MARIA MILAS: I definitely think it's a matter of perspective. There's this word constantly in clinical trials that we hear it every day, which is patient-centricity. So definitely patient-centricity should be at the forefront of our minds, and moving clinical trial activities to maybe more local and/or more digital setting could be more attractive for patients.
I remember an article saying that 70% of the patients in the clinical trials actually live more than two hours away from a research site. So there's this inconvenience of traveling to the sites that is taken away with decentralized trials, or at least the frequency. You don't have to go every single visit to the site.
HANNAH: And do you think we'll see more efficient trials if we move towards decentralized hybrid models?
MARIA MILAS: I believe that there will definitely be an increase in efficiency of a trial with decentralized trials. We can see that it accelerates patient recruitment. It increases also participant diversity, because you can reach a broader, let's say, sample of patients.
But there also will be some challenges. And I can think of, if a trial visit is run over the phone, how you can ensure patients' identity? Or, how can you ensure whoever else is on the phone at that moment?
Having more technology means that there is a higher volume of data that needs to be managed and processed, but at some point, technology may--
could fail, and you could lose patient data, which is crucial. We have to adapt.
HANNAH: It's evident that technology has played a major role in improving your work life as a CRA. So moving to work for a technology company like Teckro seems like a natural move. To finish, could you give the audience some insight into how Teckro streamlines communication and makes the clinical trial process more efficient?
MARIA MILAS: That's a good question. Let's say that, until now--
or still now--
the usual communication flow would be, sites go to CRA, CRA goes to sponsor, sponsor goes back to CRA, and CRA goes back to site. So that will be like the standard flow, which means inwards, even an investigator has a doubt, has a question, or a study coordinator wants to check something, they will probably contact you, the local CRA, sometimes even because you are in their time zone, or you speak their language, or they have your phone number.
And then you, as the CRA, if you don't have that answer, you would probably go to the sponsor directly, who asks the medical advisor. They would get back to you with a response probably the following day, because usually, if you are based in Europe and your sponsor is based in the US, you have this time zone difference. And then, following day, as a CRA, you can go back to your investigators and give them their response.
With Teckro, what we've seen is that an investigator, instead of going to CRA and waiting, maybe for an email to be responded, maybe for somebody to pick up the phone, or maybe just waiting for the CRA to go to a medical expert and then have a response, and come back the following day. Now with Teckro, sites can actually just, on their phone, open the chat, open the direct communication channel, let's say with medical experts, and just put their question. And in a matter of minutes, they have the response to their question.
Now, this experts--
of course, the CRA can be one of the experts that are delegated that are in this chat group. But there could be also maybe some medical advisors from different time zones, or some other CRAs from different time zones, or study managers.
So what we see is that with Teckro, the investigators, their sites, don't depend on one single person to get a response, and they don't have to wait. Which means the activity at site--
and as well as the enrollment--
but the activity is much faster. It's more efficient, and they actually get what they need while the patient is still on site, without needs of delays or reaching any content that you possibly could get.
HANNAH: So, do you have any specific examples of how Teckro has helped site staff?
MARIA MILAS: I was on a monitoring visit in one of the big hospitals in Carioca, here in Spain. So I was monitoring from the PI's office.
Of course, I struggled with finding a spot where to put my laptop, honestly, because imagine her desk. There were around 15 or more paper protocols scattered all over the desk. So I met with her, we discussed how the day was going to be run.
So she goes and she sees a patient. Meanwhile, I'm doing monitoring visit. But after just some minutes, she comes back in a hurry, and she starts looking for a specific protocol of the study that she was performing the visit at that moment.
But she couldn't find it. And of course she couldn't find it, because there were so many booklets, paper protocols on her desk.
So the issue was she had this doubt.
Her CRA didn't pick the phone, her sponsor was in the US. I couldn't help, of course, because I was a CRA, but in a different study. I didn't have the response of her study. So, the obvious question was, hey, do you have Teckro go on your phone?
So, you know when you can see on someone's face when they go from intense stress to complete relief? So that's what her face went when she realized that she had Teckro.
HANNAH: [INAUDIBLE].
MARIA MILAS: Yeah, that was really--
it was really nice to see how she had a tool that she could use to get the response right there, when the patient was still there. And she came from complete stress of what to do, not knowing who to reach to.
Another example I can think of is, so I was--
again, I was traveling to Vigo. Vigo is a smaller city in the north of Spain.
The phone connection was not very good there. So I was--
I knew where I had to meet with the study coordinator, so I was at the meeting point.
The study coordinator was not showing up. 20 minutes went by.
The PI was not answering the phone, so I knew I had to reach her backup. But, because I was not expecting that, I did not have her backup's contact.
So, OK, I had to look for a cafe where I had a little bit of better internet connection, log into my laptop, log into SharePoint, get her phone number, then try to contact her, talk to her, and go back to the site of the meeting point. So that meant a delay of maybe an hour.
I didn't have Teckro at that moment, but if I had it, it would have literally been just a matter of logging in to Teckro and looking at the site's contact cards. And let's say that my problem would have been solved, instead of 40 minutes, in two minutes.
HANNAH: Thank you, Maria, for giving us a glimpse into your important role as a CRA, and how it's changed in such a short period of time. And thank you to all the listeners for tuning in today.
And that's your dose of Totally Clinical. For all the listeners out there, you can follow Teckro on Twitter--
the handle is @teckroofficial--
LinkedIn, and Facebook, and subscribe to our YouTube channel. And of course, download the Totally Clinical podcast on Apple, Spotify, and Google.
See you on your next visit, and remember to bring your friends. Thanks for listening. Goodbye.
