Here’s How Investigator Meetings Can Be More Engaging

I'm just going to do the

introduction, which I'll change up later. Not the second part, but the first part, but to tie you up. So if we could mute what I'm talking as well, and vice versa, that would be great. So 3, 2, 1.

This episode I am joined by Ted Cruz, Maria Miller and Silvina baldino to discuss why investigative meetings that sometimes don't need to be such a snooze fest. Welcome to the podcast. Both of you. It's really great to have you on together again as regular contributors, and I'm so excited about the topic

we're discussing today because to be honest, I didn't really know much about IMS before and how they worked, and I was quite surprised about a few things.

I learned while researching. So how are you both doing? I am know. But we might want to change that, but.

Hi, Hannah. It's so good to be here. And it's such an interesting topic because both Sylvia and myself actually come from a field investigator meetings not so long ago. So it's going to be fun.

I'm excited. Yes I second what Maria said, and we have been on both sides, at least of the fence. I have been excited to have been a Sierra and study manager and now I am a service provider. So I have this perspective from the different points of view.

And I would like to really share with all of you our experiences with investigator meetings. Brilliant so let's get started. So not everyone listening to this podcast is going to be familiar with investigative meetings, how they function, et cetera. So silvana, let's go back to basics.

Could you explain what an investigative meeting is? Yes, I would be happy to. And I have been going on participating in different ways in investigator meeting for some decades. So have a lot of experience with them from the Ice Age when everything was paper and different.

So I think that investigator meetings have evolved. The only thing that didn't evolve is the name we are still calling them. Investigator meetings by the purpose of the investigator meeting is for the study team the opportunity to get together with site

representatives, vendors, different people that are part of the study, the sponsor. And this year of the Edison zero participating to discuss an early stage before.

In general, the studies activated the protocol, answer questions, provide additional information about the study and all the processes that involve the study help the sides to understand the best way to conduct the study. Many times these different presentations that people received your investigator meetings or the audience is mostly sites and site staff. They are considered like training. So I think that we are still calling investigator meetings these type of events because in the past it was mostly directed to investigators.

Study coordinators were not widely recognized in the past, but now, like everybody knows the importance of a study coordinator. When you are talking about conducting a clinical trial because really the study coordinator is the key of all the operational procedures at the site. So investigators recognize that. And for them, it's very important to have that person with them during the investigator meeting and is not less frequent than before to see in some investigator meetings more study coordinators than investigators attending, because maybe the doctors are seeing their skills and they cannot attend, but they rely on the other study coordinators to participate, get the information, and they go back to the sites and share with the rest of the site staff.

I don't know, Maria, if you would agree with that. Oh, absolutely, indeed. I would maybe just add that in the investigator meetings nowadays, we also have a huge attendance from the study teams. We have the project managers.

We have the study managers. We have the Sierra of the series. We have the medical managers as well. And especially for the sierras, is one of the main moments, the most relevant moments in the study themselves, not only because of all the trainings that you've mentioned so, but also because it's the first moment in the study where you get to meet and to see face to face and to be introduced to the sites that you are going to manage.

Now, hopefully, most of your sites, they're going to attend to the investigator meeting. And as you said, we're going to hopefully have the investigator and the study coordinator of each site, at least. But it gives you an occasion to have this first contact with them outside of the clinic environment. And it allows you maybe to spend some more time with them and chat through the study with them, chat through the assessments, through the vendors, chat through any questions that they might have even before actually initiating.

And it's somehow even a preparation of a Prius v right moment where you can make sure that sometimes even the Sierras come with maybe I can prepare my side so that the savvy is going to take even less time or it's going to be less stressful because we know that the invitation to the step is going to be a very stressful visit for you and for your sites as well, because it's extremely dense and intense. So sometimes these investigator meetings are even a preparation for the city itself. It's really interesting hearing both of you talk about investigator meetings, because when I first heard the term, I just didn't think so many people would be involved and they just sound a little bit complex.

Maria, could you explain more about your experiences of investigator meetings, your personal experience? Absolutely and and I would like to actually come with one specific example and picture this with me. I think it will give us a more clear vision of what an investigator meeting. So I used to be a Sierra in Spain for one of the top known Sierras.

So we were having this investigator meeting in

Vienna. It was in this case, it was a phase Ii ecology study that I was going to monitor with. I can remember the number of size where, but around seven or eight sites in Spain. So we went to this investigator meeting.

It was held at the hotel, huge hotel with huge meeting rooms. And in those meeting rooms, we stayed for four days. And when I say four days, you might think, oh, well, you know, you will have some meetings, then you can catch up with your email, then you can catch up with your site. No, it was four intense days of meetings, of trainings, of talks from 8 PM to 6 PM every single day of these four, four, four meeting days.

Now, how do you look like? Well, PowerPoint after PowerPoint after more PowerPoint. So let's picture of the first day. First and second day was dedicated for the study teams, meaning you are going to have the project managers, the study manager, the series and the medical managers together.

Going through the protocol, operational aspects, assessments. And then the second date would be for the study team again. So on the second day, you are going to go through the vendors one by one in that specific study. And I will always remember we had 14 vendors between the EDC and then specific to the study, an imaging vendor, a specific assessment vendor, the lab, the logo, the central lab pros, all type of vendors.

So we spent a full day with presentation going through each of these vendors. Now the third and fourth they came in were the investigators, and the study coordinators joined us and we did the exact same thing all over again. Day three a review of the protocol. A review of the operations, a review of the assessments.

A review of risks that we anticipated in the study. So as a theory, you go through it again as sites, you go through it for the first time, but it's a third day of intense training. Again, the fourth day is going to be the same as the second day for the series and for the medical monitors going through with the vendors that participate in the study, reviewing them together with your sites so that you make sure that if there is what's the reason why we're going through this again while your sites are present there. And some of them are international.

Right and not the main language that we're going to deliver these trainings in english, of course, but especially in Europe, not all of our investigators are going to be very fluent in English. So if you go through these trainings and you have your local series, it's easier for them if there's questions or doubts or that you might want to clarify to go to your site. Right and then you go through these difficulties and doubts together. So it was for four days that require your full attention.

And remember, it's four full days while your backlog of the other clinical trials that you managing is still accumulating, and your concern of when you're getting back to it, to your regular life, to your daily life, it's just it keeps increasing and it keeps building up. Wow Maria that sounds exhausting and stressful and to be honest, a little bit boring, I mean, to go over the same things again and again. Sophina quickly, you used the B word, boring to describe. I am.

No one wants to be accused of being boring, do they? I know so. Investigator meetings used to be different. So first, the biggest trials were not as complex as they are right now.

And investigators tend to go out all to the same investigator meeting in one place of the world. Well, now we have a lot of regional like

americas, Europe, Asia, different investigator meetings in the past were just one investigator meeting with everybody at any from different parts of the world. So the sponsors recognize the effort from some of the side stuff. Investigator and honestly, they need those maybe taking a many hour flight to be there.

So they used to have some in additional to all these presentations. And Maria, describe some off site activities like if you're in a place where the wineries go to a winery and have a tour and learn about how people make wine or do different things. But with the time, there were a lot of concern from regulatory authorities about sponsors kind of bribing investigators into investigator meetings to participate in different studies. So things change and they became more like straightforward, as many explained.

Anyway, I think that obviously virtual component has changed everything too. There are more things that you can do virtually, and we learned a lot about that with COVID. But I think that the sense of the essence of the investigator meetings remain the same. But we need to adjust to the new times.

So what Maria described for the fall days, the day, you know, you will never see an investigator meeting that long anymore, because for any sponsor that want the one for the investigator meeting, nobody will be happy to attend and they will refuse to. So investigator meetings tend to be shorter. Now, one today is one day and a half, I think is the norm. And they are trying to pack all that same information in less time.

So you can imagine how intense they are. Wow I bet the wineries were really popular. So they kind of went backwards in a way, if we can call it that. Why do you think this happened, that they're structured like this?

Is it an unwilling is there an unwillingness to change at all? Maria and I. I wouldn't say so. Hannah I think it's just that we've always done it this way.

Right and as Lena

says, we've had to find a way that we can put together a lot of training, a lot of content and deliberate to the team, to everybody who's going to participate and try to do it in the most efficient and precise way so that the information is transmitted. So I think it's just we we're replicating what we think kind of works from previous experiences. And I also think that usually those who are going to organize and prepare, put together these investigator meetings are the project managers and the AMS are just one task on to do list, right? So there is no time in their schedule, let's say, to think of ways to innovate, to think outside of the box because.

Again, as I just said, they have dozens of tasks that they need to do at the beginning of the trial, and the investigative meeting is just one of them. And another aspect that I also thought as a theory is sometimes you don't give a voice to the attendees, so you are focused on delivering. And all these trainings because again, this information is extremely essential and we have to go through with this information because you cannot avoid you cannot afford having mistakes and protocol deviations and serious breaches happen in your study. So you want to avoid them and do risk mitigation.

Right but sometimes we don't give a voice to the attendees. We are so stuck on those infinite responsibilities that we have to do that. Even during the investigator meeting, we're already thinking of what is next? What do I have to do when this meeting finishes at 6:00 p.m.?

Why do I have to do when I'm back from this investment investigator meeting so we don't allow time to give feedback to share together what we could do better? Maybe, you know, Sierra could come up with new or more innovative ideas or just maybe sometimes even take responsibility over some of the sections in the investigator meeting. Maybe do some workshops, maybe just think. Yeah, give the space half the space of how space and time, as I said, space and time to how we could do better other than perceive the investigator meeting as one of the tasks on to do list when you initiate a study.

Yeah you know what? I know. And Maria, I also think that I heard this week

somebody said that our industry is an industry of evolution and not for revolution. So and that is true.

You know, things take time. But I think that during covid, everybody learned, especially in our world, in health care, that, you know, we have technology and we can tap into that. As needed. I think that we are always extreme.

And because during covid, nobody could attend to investigator meetings. And it was very important to keep clinical research going. They moved to 100% virtual investigator meeting, which has been challenging to engage and really having people to participate because one of the most important things for the investigators study coordinators type stuff, but also for the project teams, it's during the in-person investigator meeting that opportunity to exchange to, you know, exchange experiences, to meet each other, to see each other and, you know, to share a moment out. As Maria said, not in the clinic setting, you know, different hospitals, maybe investigators or study coordinators.

They're working the same thing about the area. And they have this opportunity, the investigator meetings, to see each other and to, you know, have a conversation about this trial or maybe other trials they are conducting. So now that we are in our lives are back to normal or almost normal. And there are some investigator meetings coming back to in-person.

I think that we could use technology to do some pre-work, and I have seen that in investigator meetings this year. So the sponsor, the project team provides to the site staff before the investigator meeting some information upfront so they can really be prepared. And then when they come to the investigator meeting have shorter stations and really more discussion because if you already know some of the content that will be presented, then you can go to the investigator meeting and make they more participate, you know, more participation from both sides instead of just somebody from the sponsor in the zero giving a lecture and just the sites listening.

So if you do some pre work and prepare, then you can have a more interactive session that is better for everybody. So I'm just I'm going to ask that question to Maria, like about solutions, because you just gave a solution. So so

I'll. I'll ask that to Maria.

Sorry so. All right. So, Maria, do you have any other potential solutions that could be adopted to make IMS more engaging? Oh, Hannah, I'm a fan of workshops as engaging and as fun as we can as we can think of them, because.

Rather than focusing on going through all the content, I think workshops would help us focus on the key elements of what we want to take home with us of these investigator meetings. So maybe when we're reviewing the vendors or the tools that we're going to have in the study, maybe we could try to make these trainings as well as that more engaging, more hands on, more visual, and even more why not disruptive. So that when we go home it sticks with you, it stays in your mind. You will remember, you know, I always I know I'm pretty known

now by always using cut slides and I know it's everybody likes kids, so of course I'm going to use lights.

But it's more kiddie slides. But it's more because. Instead of having those PowerPoints full of text that they're all the same, that they're always in Black and white, the boring kind of powerpoints, if you can just associate that information in that context to an image that's disruptive, that's going to be different. That's going to stick with you.

We're visual creatures, most of them a huge percentage of the human population. So just trying to do things in a more disruptive way, thinking outside of the box, having the time to think outside of the box, because we do want the participants at the investigator meetings to just go home or go to the clinics and start the trials, having actually retained the information that we are providing them. So I'm a fan of workshops. So let's move on to optimism.

How optimistic are you that you will see change with investigator meetings, silvana? I am I am optimistic and honestly, I have the chance to attend to some investigator meetings in different countries this year. And one of the things that we were able to do in the in-person investigator meeting is to have it both or the table. So not just us, but other vendors.

So when sides go to investigator meetings, maybe our presentation is short, but instead of trying to pack everything in a few minutes presentation and overwhelm people, we provide just the information that they need. But we are available. So that during the breaks they can come, they can talk to us, learn more, and, you know, make the specific maybe side questions that they have. So that, I think is really useful.

And it's a better use of everybody's time. And the other thing I must say, that's technology I have seen like a investigator means is in which the sponsor gives iPads to all the attendees so they can answer balls during the investigator meetings. And in this way, everybody is checking, understanding, and if there is a ball and they are not answering in the right way so the presenter can go through a specific topic that what are these person in that presentation? And I think that I see some really intention to make the investigator meetings more interesting and more helpful for everybody, because at the end of the day, the reason why we are doing this investigator meeting is because we want to have a successful clinical trial for everybody.

So I think that there are many ways to get to the same objective, to achieve the same goal in a better process to get there. So I think I am optimistic. I agree Salvino with you. Definitely and maybe even I am optimistic because.

We need change. As in it's coming. Like if you think as we were saying, right. You were saying before that I used to go I went to these investigator meetings.

That was for days. We can't afford that anymore. The investigator meetings are not that long anymore before. Also, at least in Europe, we even investigator investigators, study coordinators or series, we wanted to go to these investigator meetings because it provided you the chance to visit New countries or to know new places around the world and bring your families on these work trips.

But nowadays, it's so much easier to actually have these personal trips. So that's one less attractive aspect to go to an investigator meetings. But even on top of that, we make these investigator meetings intense, boring and stressful and, and, and so dense. Why would we want to go

to it?

And we can definitely see how the attendance of the invited and target attendance to the investigator meetings has decreased. Incredibly, the last investigator meeting that we went to were expecting 300 attendees. We had very little few more than 100. So absolutely.

I am very optimistic that change has to come. That's a very positive note to end on. So thank you so much for coming on. And we're going to wrap things up.

Now But one last question. If the changes you suggested are implemented, will investigated meetings be more fun for you and less boring? Definitely definitely. I can think about if I still wasn't zero.

But even now from tech that we still like to attend to these investigator meetings. If we make

them fun and we make them light and we make them less something that we can look forward to even. I'm having an investigator meeting next week. Yay!

I want to go, too. Absolutely I would love to go to as many as possible. I agree. And I think that the investigator meeting set the tone for the study.

So with a good start, everybody positive and in collaboration, this is something that will translate during the duration of the trial. So, yes, definitely. Let's just hope this happens. Thank you both so much for today.

It's definitely been fun. See you next time. Thank you, Hannah. Bye bye. Great OK, so I'll start recording.

So, how did you think? Oh, let me just stop recording. Could stop.