THE VALUE OF ENGAGING SITES IN CLINICAL TRIAL DEVELOPMENT

 

Vivienne Van de Walle, Co-Founder of PT&R – a dedicated clinical trial site in the Netherlands, and Chris Porter, VP of Marketing & Digital Strategy, ERT, explore how involving clinical sites early on in the trial process can help simplify the study for sites, help sponsors avoid common, yet important, pitfalls and accelerate clinical trial timelines.

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EPISODE NOTES:


Vivienne Van de Walle, Co-Founder of PT&R – a dedicated clinical trial site in the Netherlands, is joined by Chris Porter, VP of Marketing & Digital Strategy, ERT for a discussion about the importance of involving clinical sites in the design of studies. Sites are on the frontline of your clinical trials and as such, bring with them a wealth of experience and advice on how to make trials run more smoothly and efficiently, ultimately bringing drugs to market faster. Here’s a summary of what you can expect from the podcast:

The Value of Your Sites Embracing Technology

Paper data collection is still used in clinical studies. Learn how a site views the importance of embracing technology to get drugs to the patients who need them, faster.

Simplify Site Staff’s Day-to-Day Lives

Keeping sites engaged in clinical trials is vital. If sites are motivated, they will be high recruiters, help achieve high compliance rates amongst patients and give you the data you need to make your trial a success. To do this, we need to make taking part as simple as possible. Eliminate multiple portals with multiple logins, ensure automatic notifications to site staff are part of the protocol to capture patients who are non-compliant and ensure training requirements are kept to a minimum.

Involve Sites Early in Your Study Design

Sites spot problems which sponsors, CRO’s and vendors may miss. For example, is the device actually intuitive to use? If not, patients are likely to be non-compliant. Asking patients with specific neurological conditions to use a stylus to record electronic diary entries may prove problematic and might result in the failure of the entire trial. These kinds of details may be overlooked by anyone but the site, yet are vital for the success of the trial itself.


TRANSCRIPTS:

Good morning and welcome to Trial Better podcast, a series where we discuss best practices and industry standards in clinical trial management. I’m your host this week, Chris Porter and I’m the VP of marketing and digital strategy at ERT. Today we’ll be discussing the importance of partnering hand in hand with sites and what we can accomplish together for patients as a result of deep insight and partner engagement.

Joining me for today’s conversations, our guests, Doctor Vivienne van de Walle, a Co-founder, Medical Director and principle investigator of PT&R. Hi Vivienne, and thank you for joining us on the Trial Better podcast. Welcome.

Dr van de Walle:  It’s my pleasure to be here. Thank you

Chris Porter:       Vivienne, thanks again for joining and we should have noted that, you are joining us from the Netherlands and we thank you for taking your time once again. We’re going to roll through a series of questions here and feel free to stop, interject and we’ll try to make this conversational. But again, welcome and thanks for sharing your time and experience, taking time away from your patients in your specific site. To get us started, can you give us a little bit of background on your experience in clinical research?

Dr van de Walle:  Sure, thank you. I actually started in the business over 20 years ago and actually I started as a participant in a clinical trial and eventually I decided to move my career into that direction. I joined an independent clinic research site, and then eventually I took it over and branded into what it is nowadays.

Chris Porter:       Now, if I recall correctly, you have a pretty unique perspective in that you have been on just about every side of this equation, have you not?

Dr van de Walle:  Yes, indeed. I have. I’ve also worked as a consultant for Pharma companies for CROs. I’ve been teaching to these parties as well and of course, but the vendors like you guys who want to hear the voice of the site.

Chris Porter:       Well, we’re excited about diving into those different perspectives as we walk through this. Can you share your perspective on specifically electronic patient reported outcome assessments and clinical reported outcomes at your sites? Specifically, how these tools have impacted your staff and process and your daily workflow?

Dr van de Walle:  Sure. You know, when I started in clinical research way back when, we were all on paper and paper’s patient. But, with the speed of today, we do need to move forward into the electronic phase. So of course we are doing that in the clinical research as well. We’re dealing with a lot of systems, many systems, many portals, many login details that we have to remember. That can be a challenge. But over the years, I mean, it has been a learning curve how to deal with all of these things, but nowadays we do see the value of it, both for us, for the patients, and of course for a drug development in general.

Chris Porter:       So, diving in a little bit, specifically there regarding the workflow. Any commentary on sort of the configuration upfront of these assessments in the electronic format, meaning the order of events, any edit checks and how that may or may not jive well with your day to day workflow?

Dr van de Walle:  Well, it all depends on how the system is actually set up. We’ve seen really good systems, we’ve seen lousy systems to be frank with you. And of course I think it’s been a learning curve as I said for us, but also for the vendors, for the sponsors, for the CROs on how to set it up. Some systems are very intuitive, some aren’t. And it all starts with the trial itself. Like what are you going to implement and how are you going to implement it and are the devices that you’re going to use, are they actually going to work for you? You don’t want them to work against you and the device shouldn’t be a trial in itself. We’ve been there, especially in the beginning. The workflow itself is… One of the biggest challenges for us as a site is that there’s a multitude of portals that we have to deal with.

On any given trial we can deal with like 10 different portals that we have to log into. And it’s not only remembering your login details, but it’s also queries are being generated at all these different places. So we do have to log in regularly to see what’s happening and we have to see whether our patients are complying. So we have to log in. So that takes away time from what we really want to do is taking care of our patients. And so we try to communicate that back to sponsors and CRO’s and to the vendors. Like can you make this easier, have a single login, warn us whenever there’s a noncompliance with a patient or when there are queries being generated that we need to do to resolve. Instead of us going in there and nine out of 10 times there’s nothing really happening, but we still have to go in there to see if something has happened.

Chris Porter:       Right. You make two specific points that are interesting. One is the technology itself, but the other you noted was the importance of configuration, which puts a premium on the study startup process and specifically the study design, preview, verify and deploy process. Many would suggest that’s the most critical phase of the study, sort of that first 90 day implementation phase. Do you feel like you have enough insight or input in general and how can we make startup easier and quicker for all stakeholders?

Dr van de Walle:  Exactly. All stakeholders. And sometimes I feel we, meaning the physicians, the coordinators and the patients are not considered a stakeholder. Other people are actually deciding what we’re going to work with. And as I said, sometimes it does work against us. To give you an example of a trial that we wanted to participate in, but eventually declined based on the device that we were going to use, but we only found that out literally just before site initiation visit, was a Parkinson trial. They wanted these patients to fill out an electronic diary, I think three or four times a day, but with a stylus. And you have to remember that Parkinson patients, they have a tremor. So you know, their hands are shaking all the time. So for them on this very small device to tick the little box was going to be a challenge and you couldn’t even say whether it was a reliable answer that they would be providing. They would have ticked a screen, but not knowing if that was the one that they actually wanted to answer.

So in our start up process, I immediately already during the feasibility phase, but especially during sites selection phase, I do ask my sponsor and my CRO, what vendors are you going to work with, what kind of tools are you going to implement? So we know what trainings are involved, what equipment we’re going to work with, and whether this is something that we think that we can work with and our patients can work with.

But much to my surprise, often they cannot tell us. They say, well, we’re still working on it, we’re still negotiating or we’re still trying to figure out who to work with. And I thought these things would be more in parallel, but I found out it’s not always happening. And sometimes we have to delay our first patient because the devices or the equipment has not been up and running yet, which I think is a shame, to have that being the bottleneck for our first patients to be included.

Chris Porter:       That’s fantastic insight. And so in that specific example, the investigator or site input just wasn’t early enough in the process?

Dr van de Walle:  Yeah. I think my recommendation would be to have it involved in the feasibility. Not saying like we’re going to use that, but have the site involved in your train of thoughts, like this is the kind of equipment we’re thinking of implementing, do you see this as as workable, doable? Or is it something that from the day to day business that you guys are doing would actually be quite challenging to implement in the clinic?

Chris Porter:       Right, right. Well, staying on that topic, thinking about the trial stakeholders, as we mentioned, you’ve got a unique perspective across several, and looking at it from where you sit today at the site level, tell us more about the timelines and the milestones of study startups, specifically related to these stakeholders as well. And how they align or perhaps they don’t always align and what we can do to better smooth that process?

Dr van de Walle:  As I said start with feasibility, have us include in your train of thoughts, like what you’re thinking of implementing. And especially during site selection visit, because that’s the next step that we have as a site, where the sponsor, or the CRO is actually coming to us seeing whether we can conduct a trial. We try to be as proactive as we can during that phase. Not only do we want to display our site, so they know whether or not we can do it, but also want to get as much information on the trial itself, look what are the bottle necks in exclusion criteria. But also what kind of equipment or e-tools or things are you going to implement that we have to take into consideration as well, whether or not we can do this trial.

Then the next phase, most of the time is actually the budget negotiations. So we do have hopefully final protocol, but that’s a totally different topic. We have the protocol. But then again, I ask what vendors are we going to work with and how many hours of training is involved to be able to work with all the equipment. Much to my surprise, I think in at least 50% of the times, they cannot provide me that information. And you know, the joke I always make is that people keep telling me — but oh, the system is so intuitive. But still need a three hour training for an intuitive system, which I think is a bit of a contradiction.

So that’s the kind of information I want, because if I’m working with a vendor and they want each of my staff to do, I don’t know, four or five hour training, meaning that I’m losing 20 hours of staff, just for this one trial. And I need to incorporate it somewhere in my budget, somebody has to pay those hours for that staff. That’s also a challenge because a lot of sponsors say, but oh that’s part of doing the business. And I keep telling them that’s part of doing business with you, because if I would not be doing this trial, meaning I would be doing something else and then I could work on that and make my revenues from that. So as soon as you want me to work on certain things connected with your trial, I need to have the reimbursement to be fair and square to my other sponsors and get my revenues. Yeah, I hope this kind of answers your question?

Chris Porter:       Absolutely. In fact, it jumps down my page in terms of the questions that I was hoping to ask you. So, I’m going to skip ahead and then skip back. Given that you mentioned training and intuitiveness of systems, what in your view would improve training and investigator meetings? And how do you think about e-learning systems or online tools to support that with those things? Help, is there anything sort of wrong with the traditional method or should we be more forward leaning in how we think about training?

Dr van de Walle:  Well, I am still a believer of good investigator meetings, face to face meetings. Because when you’re having a face to face meeting the dynamics and the conversations are always different, more dynamic I think when you’re doing webinars and things like that. But of course a lot of physicians find it difficult to step away from their clinics and spend time at at these meetings. I myself still find it valuable to go down there, but it has to be a good meeting and have a hands on training with the devices and get my certification there. I can’t take my whole staff with me. So we need to have a combination of ways to train everybody involved in the trial.

So if somebody has like the hands on training, if they’ve done that at an investigators meeting, and we have e-learning, we can help each other to get through it. What I think would be very beneficial is that e-learning is often generic on the device itself, but not protocol specific. And once you’ve done that, I think other sponsors should be able to accept the fact that you had the training, you are familiar with the device, you are familiar with the vendor, you are familiar with the portal and you don’t need to do to training over again just because it’s a different sponsor. Nowadays that is still happening in most of the cases that we’re duplicating our trainings, which I think is a waste of time, which we better should be using for recruiting patients for the trial.

So if we could change that and then perhaps have a small protocol specific training, either e-learning or doing the site initiation visit on specific things that you need to know for the protocol, I think that you’ll be covering the whole scope of working with the device and that would be very…. I think that you would cover everything.

Chris Porter:       Well, you’re clearly suggesting taking a strategic approach to the overall training plan and what I hear you say is making sure you’re taking into account certain potential pitfalls. Like you can schedule your investigator meeting and then you may have a four month delay from that meeting to first patient in, in which case you need to think about refreshing, and maybe that’s the role that technology plays to bridge that gap and move through that early critical startup phase we mentioned before.

Dr van de Walle:  Yeah, it’s not just one, I think the combination is the strength.

Chris Porter:       Perfect. Perfect. I know we’ve talked about a few topics and there are some challenges woven in there, but I know people listening would love to hear more of your comments on some of your key challenges at the sites specifically and some of those big topics such as maintaining patient compliance. Why don’t we start there and get your thoughts on maintaining patient compliance and how process and technology can help?

Dr van de Walle:  There’s a huge responsibility at the site level on patient compliance. And it’s explaining to them why the e-diaries or the wearables or whatever we’re implementing is so crucial for the clinical trial to get the data. Paper diaries, we know that they’re unreliable, so electronics we have high quality data, we have real time data so we can follow up with the patients, whether or not they’re compliant. And it does help when there’s automatic warnings sent to the site, like, this patient isn’t been compliant, please follow up with them.

So all these things, when these are implemented makes that, at least from our site, we have a very high compliance with our patients. But again, it’s explaining to them why this data is so important, why their entries into these e-diaries are so important. The challenges that we do have is when patients are traveling, especially when they’re going to different time zones. Can we change the time in the device or not? Sometimes the sponsor doesn’t allow us. So meaning that they have to wake up in the middle of the night to answer questions in the e-diary, or otherwise the e-diary will actually give them an alarm in the middle of the night, which I think is very inconvenient and not very friendly towards the patients. Devices can malfunction and it’s always good to have some spare ones that we can switch whenever something like that happens, so we have sufficient equipment on our site to do that.

One of the things that we really like is help desks that do help. And sometimes some sponsors, I don’t know why they say it, oh, but you can do it all as a site. And of course we do have years of experience with all these devices and there’s a lot of things that we can resolve, but still, I don’t think we should be the first line to resolve the issues. I think it’s the vendor who provides the stuff should be the help desk. For two reasons, is that, again it’s taking me away or my staff away from our day to day work because these people call us randomly, most of the time they have to enter their diaries at night, so of course they call me because they all have my cell phone number. So I’m getting these calls in the evening, and of course I help them, but I do have a social life as well sometimes. The other thing is, if we always resolve the issues, then the sponsor and vendor doesn’t know there are any issues. So there’s no learning curve there and I think it’s crucial that we do share that information and it’s not like witching and whining, but it’s to know what are the challenges when we’re using these things and how can we learn for the next trial and blueprint and move forward and even do better on the next one.

Chris Porter:       Well, we certainly would like to help you have a social life…

Dr van de Walle:  Thank you.

Chris Porter:       — and you are again, highlighting the key point here is that partnership and sort of multimodality interaction with the patient, depending on what the issue is. For certain issues, I’m sure you’re happy to pick up your cell phone and for other issues, first line help desk support is the right approach. Relatedly, to patient compliance, closely related, tell us about patient engagement and what methods you use or in partnership with technology and service providers can help engage patients to improve operational success? We’re talking about software devices, you know, additional training and support.

Dr van de Walle:  Keep it simple. You know, if there’s one statement I could make it’s just keep it simple. Just like with consumer technology, it’s simple. If people can buy it then they use it, a lot of people hate having going through manuals, they just want to pick it up and use it. So when we have to spend half an hour or an hour with the patient to explain the device, that is going to be a challenge for a patient to be compliant. When it’s so logical you know patients are going to use it because it’s, as I said, it’s intuitive. I was going to say something about that, but I just forgot about it. Anyway…

Chris Porter:       That’s OK. So when you think about how technology can engage, in addition to the principle objective of collecting that outcome data. In terms of reminders and alerts, you mentioned [inaudible][21:17] notifications, content pushing, those types of things, how have you seen that help in the process to keep patients engaged and aligned along their schedule events?

Dr van de Walle:  Definitely. The thing I was going to say is that some people assume that it would be more challenging for elderly people compared to youngers, because they aren’t used to work with a technology. That might have been the case 10 years ago, nowadays we don’t see any differences. I see 70, 80 years old picking up the e-diaries or whatever we have and working with it and being compliant, just as easily as an 18 year old. So, because it is implemented in our day to day life, I don’t think that is a challenge anymore. But we have to make it simple for them to use, don’t make it complex and make it logical for them. And have them see the value of the data that they are entering. I don’t get any questions on privacy because they know they don’t enter their own personal information, so there’s no reluctance there. And most of them, it doesn’t even take a lot of time to enter the data, so that’s easy for them to use as well.

But I think explaining is crucial. I remember this one case as an example that this patient said, but hey, listen, I’ve been compliant for like, I don’t know, 75% of the time isn’t that sufficient? And then I tell them, if you buy a new car, you need your four wheels on that car to test drive it. Don’t put 75% of the wheels, meaning three wheels on the car and then test drive it. So we need all that data, we need the data from day one, in the middle and in the end to make a good judgment on the drug that we’re researching.

Chris Porter:       Makes Sense. So, simplicity, training, collaboration, feedback was one of the things that you mentioned, in terms of keeping that patient aware of their own status and how they’re doing, all of which would help maintain their interest going forward throughout the trial. Very helpful.

Dr van de Walle:  Sometimes we had a trial where even numbers were being shared, not so much data, but like how many patients are participating, how many data have they generated, things like that. And patients were intrigued by the enormousness of the data that was being gathered in the content of the trial.

Chris Porter:       Well, it gives them an idea that they’re participating in something larger than themselves, right. And I think that’s part of why they agreed to do it with you at the outset, correct?

Dr van de Walle:  Exactly, yes.

Chris Porter:       So as a technology and service provider, how do we improve collaboration generally and make the process better for your team? You’ve hinted at a few things, but I was hoping you’d speak to that specifically.

Dr van de Walle:  The unfortunate thing is that we often don’t, well I’ve never been able to choose which vendor I was going to work with in a clinical trial. Fortunately enough some sponsors have a fixed collaboration with a vendor, so every time we do a new trial, then we know what vendors we’re going to work with. And then it’s easier, then you know you have a jumpstart. There’s, as I said, blueprinting, even login, my login name is the same, the portal is the same. You have multiple trials within the same portal, making life so much easier and the trial much more efficient for us to conduct.

So as long as I don’t have a say in what vendor we’re going to use, I still hope that we can have those jumpstarts when we’re working with the same vendor, although it’s with a different sponsor. That we can actually show them, we’ve worked with them, we know how their devices work, we know how their portal works, they’ll have us go back to square one, with all the training and start from scratch basically. The other thing is that we often know what’s out there, we know what you guys have to offer. Some sponsors take the whole package and some of them don’t. And it can be frustrating when we know that you guys have these emails warning us about noncompliance or whatever. One sponsor actually allows us to have them and the other one says like, no, you don’t have it.

We often have discussions with CRAs, saying — oh, but they don’t do that. I said, they do it, but you guys didn’t incorporate that in your contract or whatever you have with this vendor. My experience over the years is that we do have more knowledge than the average CRA that is coming to our site, which is frustrating for both parties because we have an issue and we explain to them, but in another trial, this is how it was resolved and the CRA is a bit reluctant. We’re sitting there telling them how it’s actually working and they don’t have a clue about it.

So I think there is also something for sponsors to be aware that CRAs should be trained very well in the equipment and the vendors that sites are going to work with, because they are dealing with our day to day issues as well sometimes.

Chris Porter:       So it’s interesting, on the one hand it goes back to the unique perspective of the site and what I heard there clearly is that you have visibility across vendor, across sponsor, across CRO as an example. And we should recognize, we as the part of the community, should recognize that knowledge and leverage it, and understand the lessons that you learned working across trial, but not just across the studies, but across all the different approaches.

Dr van de Walle:  I often challenge everybody — pick my brain, just please do it. Because we want to be constructive, we want things to work for us. We’re all in this together, we all want good data, reliable data, quick start up timelines, quick recruitment. And we can only do that when we’re actually looking at each other and joining hands, instead of being at opposite sides and saying like, oh my God, are we going to work with this vendor again. But as I said, no witching and wining, be constructive and find solutions. That’s what I always wanted to do in my work is, OK, it’s not working, but what can I do to make it work, and if it’s not working for this trial, hopefully we can have it work for the next trial. But then again, there’s a responsibility from sponsors and CROs to have us as a site, or sites in general included as early as possible in the process so we can see sometimes bottle necks from the working floor that a project manager at a CRO might not even emphasize that that’s going to be an issue. As I said, the Parkinson example is a perfect example. It all made sense to have it easier for patients, so we do an e-diary and you can look online but don’t do it with a stylus, that was the only mistake that they made. And it’s actually making or breaking a trial by such a simple thing.

Chris Porter:       Well we know there are key decisions that can do just that, that can make or break a trial and key to incorporate all the stake holders as you point out. So a related question that occurs to me is when you have this vantage point, are there key differences that you see across sponsors, even when the vendors may be the same? So they may be two different Pharma companies using the same CRO, same technology vendors, yet they operate in a very distinct way that is notable to you, worth commenting on a course without naming names.

Dr van de Walle:  Sure. One of the things that sometimes they want us to be the help desk and then if we can’t resolve it, that we call it the help desk. Other ones say, no, the patient can call the help desk themself. Other differences are, as I said, the notifications, automatic notifications, some have done automatically and the other ones [inaudible][30:14] we haven’t incorporated that into this trial. It’s the service packages I think, that are often different. The device set up I think is pretty generic by the way a vendor sets it up. So that’s not really different between the various sponsors. It’s more, as I said, the service package around it, make it easier for the site to work with the device. And the other thing is getting sufficient supplies and getting it in time, which again, is something that a project manager from the sponsor often sets up, like whether you’re a high recruiter or a low recruiting site, they will ship a certain of systems to you. I always want to have at least one spare supply in case something breaks down. I don’t want losing patients over noncompliance because their e-diary is malfunctioning, they’re an un-compliant. We’ve had this happening, patient has to be 80% compliant during the screening phase, there is a malfunctioning device, we weren’t allowed to do it on paper. Patient device broke down. We don’t have a spare. He’s 75% compliant, meaning he didn’t meet the inclusion criteria. We weren’t allowed to rescreen it. And so I lost I patient over a device, which I think is totally unacceptable and it’s not something that I can explain to a patient that it wasn’t his mistake, he couldn’t do anything about it. I was able to substitute for that and it’s not that he is not going to benefit from the drug, in contrary, because he was actually fulfilling all the other [inaudible][31:55] criteria, but he was not compliant on the e-diary.

So I try to explain to the sponsors — make sure that we have sufficient devices, that if something breaks down or something is happening that we can replace it, because I don’t want to lose patients over technology. And of course there are fortunately sponsors who say when that’s happening, you are allowed to re-screen or extend the screening period, but they have to incorporate it their protocol of course, whether do you can do that or not. Perhaps it’s something from a vendor’s point of view, it’s something to consider as well how crucial is the 80% or the 75% compliance, and how can we resolve an issue and not lose a patient over technology?

Chris Porter:       Right. Very interesting. Well, thinking about the process as well across those sponsors and CRO vendors, have you seen different approaches to your involvement in UAT? And are you involved at any point in time and would you like to be involved at that upfront stage of making sure that it’s configured according to protocol and according to the operational reality?

Dr van de Walle:  Me being here today, I think yes, shown that I want to be involved. As I said, we’re all in this together and we can only learn from each other. By doing that we can improve timelines as well I think for a clinical trial. What we can do, of course I think it varies of what devices you’re going to implement and what kind of trial it’s going to be. And perhaps it’s not trial specific, but more generic on a device, on layout of devices, how you’re going to set up certain things for certain patient groups, make it more generic in that sense. Because I know timelines are very comprehensive and very challenging sometimes at the start up of a clinical trial. So if we can be proactive in looking at certain things that you’re going to implement, like how can we make it in a way that is going to work over and over again when we’re working with this specific patient group.

But the other things that I challenge sponsors and vendors is give us a device and my staff and I will play with it and we’ll get back to you within, I don’t know, 48 hours, three days, whatever, with some preliminary feedback on what we think about it. Or if you want to have us test it with a couple of patients. Is this something that’s workable for you? Is this something that is clear to you? Is it easy for you to use? We’re more than willing to do that. And unfortunately enough, people say — oh, that’s very nice that you’re offering and it’s something that we’re very interested in, but it’s hardly ever been been done. We hardly have ever been asked to do that, because well, you know, the timelines are so strict so we don’t really have time to ship it out and then get your feedback.

So that’s why I say, let it be proactive. It doesn’t have to be protocol specific, but can we look at a more helicopter view of certain things? But it also goes with EDCs. Some EDCs are so logical for us to use and other ones we’re struggling with, despite the fact it is with the same vendor, but it’s so difficult to find the correct pages where we have to fill out everything without forgetting anything. Help us as a site to make that simple, because we don’t to forget anything, we want to fill out everything. But working with multiple systems, it’s not always that logical to find all the pages and you think you’ve done it all, only to find out that there were three other pages hidden behind somewhere else that we had to fill in data as well.

Take into consideration that we’re working with more than one system and it’s not our day to day job to be into technology, it is something that is helping us to conduct a trial, but it’s not the core business of conducting the trial.

Chris Porter:       So while you’re saying there’s effort and some complexity in being involved up front, it’s worth it from a downstream issue, resolution and anticipation and something we should consider doing more of it. I think that makes a lot of sense.

Dr van de Walle:  Yes, please. I know I’m not the only site who you could approach to do that.

Chris Porter:       Perfect. Well as we move to wrap up and sort of bring it back up to the technology level, as we think about eCOA, how would you describe the value of eCOA in three words?

Dr van de Walle:  Well, the e in eCOA, I think in three words, is it shortens timelines. Meaning that we get a drug quicker on the market, meaning it’s available to our patients quicker, meaning we can save lives. I mean, what more do you want?

Chris Porter:       That pretty much says it all I think. And I appreciate the simplicity of that answer and it’s why we’re all here.

Dr van de Walle:  Exactly.

Chris Porter:       I want to thank you very much for your time. It’s been incredibly insightful and I want to give you an opportunity for an any other final thoughts that you want to leave us with as we wrap up.

Dr van de Walle:  Well, thank you for that opportunity. You know, technology’s here and it’s here to stay. So we’re not going to get away from it. It has proven its value with higher quality data, reliable data and that’s what we want. We want to draw conclusions on the drugs that are being developed. As I said, we want to have it quicker on the market, we want to have it quicker to our patients and for certain drugs, meaning that we are actually saving lives. If we can do that by using technology, I think it’s a no brainer to do that. And for other sites don’t be reluctant when this is going to be implemented, take it, embrace it and it has a huge potential and I think we’ve only seen the beginning of it. I think the next step is going to be the virtual trials where patients don’t really have to go to the site all the time, where we can monitor where ever they are and we can do things on a distance. So I’m looking forward to the future and what it has to bring with all the technology.

Chris Porter:       That’s a perfect wrap up. And we’re very thankful for you taking the time and you have certainly given us and our listeners a lot of things to consider and some provocative insights as well. So we’re very much appreciative of your time and look forward to the next opportunity to talk. Thank you very much Dr van de Walle.

Dr van de Walle:  Thank you very much for the opportunity.

FEATURED GUEST:


Viviënne van de Walle studied medicine both at the University of Maastricht and at the University of Oxford. In 2004 she successfully defended her thesis for her Ph.D. and in 2011, she passed the CPI exam. She has always combined clinical research with patient care and has been a full-time investigator at independent clinical research sites. She co-founded and owns the independent research site PT&R (www.ptr.nu) since 2006. Her entrepreneurship is reflected by her skills as a thought leader and in consulting, education, management, and executive functions at CROs, pharma and trade organizations i.e. ACRP, SCRS, TransCelerate, and NVFG. With her PT&R-team she was also the proud winner of the inaugural SPRIA EU. She started her research career as a participant in a clinical trial. As a result, Vivienne has a unique perspective of the various sides of the table in clinical research and is eager to share her many years of experience.



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