Closing the Gap in Clinical Trial Communication

Hello and welcome. And today, we're going to look at the topic of communication that we know that clinical trial success is dependent on effective communication between study teams and research personnel. And yet when we talk to sponsors, they aren't really sure the best way to communicate with sites that is helpful for them. And on the other side, we know that research staff are often frustrated at how long it takes to get answers from study experts.

So in today's session, we're going to look at a simple, modern way to connect investigators inside staff with both the study instruction in the protocol, as well as expert guidance when and where they need it. And we'll also look at how study teams gain critical insight into both trial performance as well as engagement. Now for today's session, I'm joined with a couple of tech experts. First, we have Andrea Parrish, who is tech co-head operational excellence.

Andrea has been in the industry for quite a long time, so she's very well-suited to talk through the challenges and also to present a solution for us in terms of bridging the gap of communication. And second, we have Declan O'Dwyer, who is a tech product manager. And if I'm not mistaken, he's one of the very first employees at tech grocery. He's been here for quite a while.

He'll talk about some research that we did for the launch of a newer product within the communication side of the tech portfolio. And he'll also take us through a scenario to show the potential of how this product can work to bridge that gap myself. I'm Kelly brown, and I am the chief marketing officer for tech growth, and I'll be moderating this session. For today's agenda.

We have a few simple things we'd like to accomplish. So, first of all, I will go through today's challenges with communication. Next, we'll look at a new approach to New way of thinking about how sites and study teams can be communicating. And then we'll look at a sample scenario flow of what is possible.

And finally, I hope we will have piqued your interest enough that you want to find additional information. And so I'll point you to some additional resources at the end of this presentation. Andrea, over to you. All right.

Thank you, Kelly, for the introduction and for the opportunity to speak with everyone today. Well, let's just get started. When we think about the challenges involved in conducting clinical trials, I think we can all agree that there could be a number of contributing factors. We know that sponsors and sites are focused on the overall safety of the patient and that the trial is conducted in accordance with the protocol.

And in order to manage these responsibilities, it requires efficient and effective communication with the key study stakeholders. So taking the challenges we just spoke about into consideration and knowing how important it is for sponsors and sites to meet their objectives, the lack of effective communication is a key component to contributing to some of those challenges. In addition, inefficient communication has a direct impact two variables that are absolutely critical for the sponsors and sites during the conduct of clinical trials, and these include time cost, quality and compliance and visibility.

So we know that the inefficiencies in communication exist across a number of stakeholders. But I wanted to focus this discussion today on two distinct groups, specifically sponsors and sites. So why focus on just these two groups specifically? Because ultimately, sponsors are required to maintain oversight of all trial conduct related to their protocol or study, and sites are required to ensure the safety of the trial subjects and remain in line with the requirements of the protocol.

So the inability of these two stakeholders in managing this these requirements has the potential to put the trial and the trial subjects at risk. So this would be an issue. So communication is key. So what are some of the challenges experienced by both sponsors and sites?

Here's a few that just stand out that came to mind specifically for sponsors. I would say that there are multiple stakeholders and oftentimes it is very hard to align on key decisions. Also, delayed response times from sites and series is very common for sponsors. Finally, there is no visibility in any site activity.

You don't know what documents they're referring or referencing as an example. You have no idea what's happening out there at the site. So what are some of the site's challenges? Well, it's difficult to get protocol clarifications resolved quickly.

We know that there are important study details that are actually buried in email that are never actually accessed. And for those of you out there that work with multiple sponsors, you do know that you're working across multiple portals for those different settings. So you can imagine how difficult it is to try to manage in between all of those passwords. So also finally, four sites, I would say managing multi-site trials and streamlining that communication.

What we've been told can be very, very difficult. So as I mentioned previously, we need to address not only the impact of inefficient communication on sponsors and sites, but we also address how that inefficient communication has a direct impact to time, cost, quality and visibility when conducting the clinical trials. So let's talk about what can improve clinical trials, and I want to talk about how to approach can help address some of those variables that we've been referencing. So just to get you oriented, we just to let you know that tempo has three pillars which can help sponsors and sites improve the clinical trial process.

So what are those? These are insights, content management and communication on the whole. But, you know, having mentioned how important communication is to sponsors and sites, we're going to focus on this key area for discussion and specifically how it relates to those attributes. We spoke about time, cost, quality and visibility.

So let me elaborate on a few examples on how tech broken can have a positive impact on these variables. So let's start with time. Well, we all know that time is of the essence. With sponsors and sites, it means everything.

So with tech row, what you can expect are faster answers to your protocol questions because you can get those answers right in your palm of your hand. Quicker decisions and in terming eligibility of patients. Our study participants, I mean, this is critical when they're sitting in your office and you have limited time with the patient and the protocol, and you're going to have faster clients or access to critical site information, which often is not happening. It's sitting in binders on a shelf.

Right so next, let's address cost. We know that money matters and the cost of doing business is quite extensive in the clinical research space. So sites and sponsors are always looking for ways to be cost efficient. So with tetra, what can you expect?

You can expect fewer protocol, deviations and quality issues. Having that seamless communication channel reduces the probability of those instances occurring because you're getting the right answer the first time. You're also you can also expect faster recruitment by connecting with the sites and keeping them engaged all throughout the study, which is rare. So now let's talk about quality.

We all know that the goal in the clinical trials space related to quality is compliance with the protocol. So what can you expect to grow in this space? It would be proactive compliance. You're actually de-risking the trial in real time because of the features of our platform.

You're able to understand what those risks are and manage it with the tools that we have, particularly our communication channels. You also have direct access to medical experts with our product. And finally, in this space, I would say that have a targeted communication channel, and we all know these. We would much prefer a targeted message in your hand versus waiting through spam.

Those emails never get read and therefore you are getting information that is irrelevant for you. So finally, let's discuss visibility. Right now, we know that there is zero visibility into how teams are accessing information about the protocol or starting study documents. You have no idea what they're touching or reading.

So but what you can expect with tech row, though, is access to who is interacting with the study documents and when. Also, you have the ability to see who is opening and reading study messages. So you can begin to gauge who is engaged with your study, which is critical for all clinical research trials. And then finally, you have immediate feedback to assess, study, feasibility or sentiment regarding the study.

Again, all of these are ways in which you can improve the clinical trial process in the communication space. All right. So as you can see, the tech platform can have a direct impact to the communication challenges faced by both sponsors and sites. The communication streams we just spoke about are seamless, directed and instant and can help you manage the variables that are absolutely critical for success during the conduct of clinical trials.

Specifically, as it relates and coming back to it again, time cost, quality and visibility. So back to you, Kelly. Thanks for taking us through that, Andrea. And I would like to pause for a moment here to just set the context a little bit more around the tech product portfolio.

So as you can see from this chart here, Andrew has taken us through the three pillars around insight, content and communication around that. We have several different products that you can see. So we have tech search, which is related to the content side. On the communication side, we have tech connect, tech engage and we have tech survey and they'll serve different purposes.

But for the point of today, what we'd like to do is talk a bit more about tech connect, which is one of the newer products within the portfolio. And for that, we'll have Declan take us through from product manager perspective the explanation of how and why we came to ad tech or connect to the product portfolio. And then he'll take us through a sample of how it can actually be used. Thank you, Kelly.

So I'd like to start by giving some insight into the evolution and background of tech connect, which essentially can be described as a communication channel, which allows sites to speak directly with medical and study experts. The common recurring theme that we found when speaking with sites was that they frequently become blocked, and it's a direct result of poor and inefficient channels of communication. And we found that this lack of direct engagement with the experts are a source of truth, if you like, and can lead to a lack of trust in the integrity of the information that they're receiving.

And it also leads to unnecessary delays. And sites are often delayed for disruptive really long periods of time. And when waiting for term vacations. So by introducing this direct channel with the experts and removing the potential need for clarification to have to come through a third party.

And tech reconnects and not only improves the time resolution for sites, but also improves the level of trust in the integrity of the information that's being returned. And then with sites unblocked and they can move forward with their day to day activities unhindered. And this ultimately leads to improved site engagement and productivity. So I would like node to walk you through a sample user flow of how Tech Connect could be used in a clinical setting and support.

Noting that in this scenario, key to the trial success is that the study experts can respond to questions in a very quick, a very short time frame. So in this scenario, we have a principal investigator, Dr. Michaels, who needs clarification and how to proceed with treatment for a patient who has experienced skin reaction and is first port of call is to search for the relevant protocol instructions on his mobile phone using type of search. Having done this, he then finds that he needs for furniture, for patient, determine whether the patient needs a dose reduction or where the treatment needs to be interrupted.

In order to do this, he simply types this question into tech, reconnect and starts a conversation with the team of experts on a supporting site. Then we have a group of medical monitors who form a team of supporting experts. And they are fully prepared to respond to messages when received. Having been trained on tech or connects, they are ready to react when alerted and as tech reconnect supports rapid alerting.

All of the team will be notified when a message is received, whether that's within the application or by email or push notification on their mobile phone if you happen to be offline at that point in time. So in this instance, one of the team responds to doctor Michael's, informing him that, yes, the treatment should be interrupted and doctor might extend. Having read and having read the message, the physician needs further clarification around how best to proceed with treating the patient's skin reaction itself. And he simply asks an additional question.

In this instance, a different member of Team responds and terrifies how best to proceed with the treatment. Once start to meet, the standards confirm that he's happy with the information that he's received and is clear, fully clear as how to proceed. And any member of the team can then resolve the conversation at this. The conversation can be exported to PDF for inclusion with trimester form.

So in essence, here we have an example of a research team answering the question, making the right decision in a timely manner, and maintaining the patient safety and doing so all in compliance with the protocol. The scenario that Declan just walked through with us is not just theory. We recently had a phase Ii study where a research team needed time sensitive guidance related to the participants safety, which is always paramount in less than 15 minutes. The principal investigator had everything that they needed, and it started when the study coordinator using tech research to find a protocol instruction.

But the pi needed further clarification. So what happened next was they used the tech reconnect feature and they initiated a conversation with a medical monitor who responded to the question within 4 minutes, which is unheard of, as we all in this industry. So after a few more clarifications, the research team was very clear on exactly how to proceed. So all this, as you can imagine, in just minutes.

So imagine in the old model how long this exchange would have taken. We all know there is no comparison. So that concludes my summary today, and so I'll kick it back to you. Kelly Andrea, Declan, Thank you both very much for your presentation.

So if I could summarize briefly what we saw today. We talked about communication and really bridging the gap between two main groups, sites and sponsors. And we also talked about four key components that are absolutely critical when we think about clinical trial operations being time cost, quality and visibility. And of course, sites have a role to play in that and sponsors have a role to play in that ultimately for the betterment of patient safety.

And we also talked about tech row and the fact that our platform is organized in three key pillars. But today we really drilled into the communication side. And as we saw with Declan, it really allows for a new approach for research staff to directly connect with monitors, study experts, however you want to structure your trial, but really allow for that direct, real time communication. So no more back and forth with email and no more time delays.

It really puts the answers at the fingertips of research staff, which again, is going to help with the four components we talked about and ultimately improve the trial quality as well as patient safety. And so from here, I'd like to wrap up, but I'd like to do is share some additional resources for people. As I said the beginning, hopefully we peaked your interest and you'd like to know more. So the first place is to visit terracom, which is our website, where you'll find more product information.

But we also have quite an active blog. So Andrea, for example, is a regular contributor and she's written quite a lot actually on the topics of quality management site engagement and others. So you might want to look at the blog in addition to some of the other resources that we have on the website. Second, if you'd like to have a demo, you can email us at demo tech Broadcom, and we'll have one of our subject matter experts set up a demo specifically for your particular needs.

And finally, if you are on social media, we are on social media. And we love to connect with you. We're quite active on LinkedIn, but you'll also find us on Twitter, Facebook, Instagram and of course, we have a YouTube channel. And so with that, I Thank you for your time and attention and good day.