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HANNAH LIPPITT: 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.

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HANNAH LIPPITT: It is not overstating it to say that clinical research has a workforce

issue. This is a problem because every one of us benefits from the hard work of staff at all levels of the industry. Now the reasons for the workforce shortage are multifaceted, and here today to discuss more about this topic are Judy Galindo and Monica Cuitiva, co-founders of Latinos in Clinical Research, an organization to help increase Latino participation within the research community.

Hello, Judy and Monica and welcome to the podcast. Now, let's start by examining exactly why there is an issue of workforce shortage in the

industry, starting with you, Judy.

JUDY GALINDO: There's various issues that are contributing to this. One of the things that a lot of people don't know about the clinical research industry, so they don't know, there's so many different job opportunities or those who might have heard about it don't really know how to get started to get into the industry and learn about it. And then those that are in the industry that maybe don't have a lot of experience have trouble advancing or going on to other positions because the lack of training.

So clinical research has been around for a very long time. I think, in general, people don't really understand what it is compared to someone who's a doctor or a vet, and I think that's why we have a shortage in the industry. But if we have more opportunities out there to get more people into the industry in the various communities, we would have a lot more people that we can put into various positions, whether at the site level, at the sponsor, CRO or vendor level.

HANNAH LIPPITT: And Monica, what are your thoughts?

MONICA CUITIVA: It's also known that the research industry – or what we do in research – is not a popular topic. I mean, nowadays with COVID, it became a little more popular. But we need to educate people about the clinical research industry and what it is to be part of this. Sometimes people are scared of jumping on a different industry, especially this one that seems to be only for people with white coats, right? So that's another factor that could be affecting. So we

need to start educating the younger population about it so that way we can break that stigmatization about this industry and obviously giving the opportunities to those that are entering industry as a new entry-level positions. In that area, we need to expand, especially the sponsors and the CROs, to give opportunities for people to do entry level positions, because the majority of this get through the clinics, the clinics train them and then the sponsors get them, unfortunately because of the shortage in the industry.

HANNAH LIPPITT: I know that there's also a problem of retention. Once people have been recruited,

they don't always stay for very long. Why is this and how can we resolve this? Starting with you, Monica.

MONICA CUITIVA: OK, so I was mentioning before that the reason why is obviously because of the shortage. So the sites train, oftentimes this new entry-level positions, and then, and then they get opportunities or they see opportunities to go higher, which is normal, right, within the industry. However, if the whole industry, they get the CROs, the sponsors and the sites give opportunities to these entry levels, it will naturally bring, obviously, more professionals, but then at the same time, it will bring diversity as nowadays due to COVID, people have a little bit more knowledge about what is research. And I think this is the great opportunity for us to educate

more about it. This will help also the industry shortage and therefore also the retention.

HANNAH LIPPITT: And Judy, Monica talked about how the companies need to give opportunities to entry level people who don't necessarily have much experience. How do you think that this can be achieved? Because a lot of companies, they demand experience.

JUDY GALINDO: Being a site owner for a small research center, I think there's a lot of things different companies can do. Opportunities such as offering maybe internships, entry level training opportunities where somebody can get started at your site and from there you can see what their strengths are and maybe what you can transition them into. So, having those resources available could help with hiring and retaining staff, what opportunities do you have that you're going to offer at your company to get in and to be able to advance? Because that's what people are looking for. They want to get in the industry. They want to work in this field and they want to move up into and find that position that works best for them.

So, we have to be able to offer those opportunities, but we need to have these available at

various time points, I guess, when you enter clinical research. So not everybody has that experience as Monica mentioned and we were talking about. So, what are we going to do to change that, to get those people in and what can we offer at our sites, at the sponsor, vendor, CRO levels to get these people in?

MONICA CUITIVA: And Judy, I would like to mention also that

sometimes you see that they post jobs that they say “entry level”, but they require one year experience, so that's not a true entry-level position. What we really need is true entry level positions.

HANNAH LIPPITT: Sponsors and CROs definitely play a role in resolving this problem. Judy, I know you have some thoughts about resources.

JUDY GALINDO: I think a lot of the protocols that we are working on that we get at the site level have become more challenging in regards to the criteria, inclusion criteria, exclusion criteria, the type of participants we're looking for and what we're collecting in the study and in the protocol, a lot of different electronic systems, different vendors, portals or diaries that we're using. And so sometimes I feel as a site that the sponsor CROs give us the study, they give us all these things that we need to use and they don't really provide much support, training, additional resources to help sites like ours recruit, manage the day-to-day aspects of the study, use the various systems so it becomes challenging. And so it pretty much falls on the sites and the site staff to figure this out, to make sure they have the staff that are trained on how to use everything that we need to use, all the protocols and we have to get additional staff sometimes to support specific protocols, and sometimes we have five or six people working

on one protocol alone when we have various other protocols going on at the same time.

So as a site owner, site representative, I've actually reached out to sponsors and CROs and have asked them, “What support can you provide us? Because we need help, we need assistance.” And some have been very responsive and have provided additional resources, others haven't. So I think we just need to change the way studies are designed a little bit easier and support sites more on these studies.

HANNAH LIPPITT: And Monica, I know that you also have some thoughts about training as well.

MONICA CUITIVA: Sometimes the sponsors forget about or actually don't really know how the sites work and I think that's why people took part that they need to get this communication, this true understanding of how the sites work. Because oftentimes, let's say in one study, the staff members could involve doctors, nurses or other type of clinicians. And this could become costly for the site to train all these people because nobody is going to work for free, right? Unless you're part of a company that does that. But for example, sometimes when the clinicians come for training and then the sponsor oftentimes just pays very little for this kind of training, so the sites take into their finance this part, right? And then the sponsors need to be more in touch with the sites, so that way they can understand the level of work that takes place in the sites.

At the end of the day, the site is the one that do the hard work, the ones that go to the field, get the patients, do all

the testing and complete the protocol, right? So, it is important that the sponsors understand all this process and the difficulty oftentimes that is involved in all of this so that way they could do a better work. And I think that could be obviously reflected in better studies, in more diverse studies, also, because the sponsors also sometimes make it difficult for the sites to get this diverse group that is needed in every study. So the support definitely needs to be bigger for the sites.

HANNAH LIPPITT: Are you optimistic that this will happen?

MONICA CUITIVA: I am. I think it will happen and it will happen whether the sponsors work right now on it or not, because the statistics show that the population is going to be

highly diverse. Just United States overall and then on top of that, the new professionals come in, which are the new generations are looking for companies that have more meaning, for companies that work more towards these kind of goals, that involve more diverse, that works for everybody.

JUDY GALINDO: Yeah and as a site owner working at a site level, I have seen this with some sponsors who have invested, you know, their time, money, effort to support sites and to make this happen. So I am optimistic it's going to happen. It is a slow process, but it does involve a lot of players in order to make a difference.

HANNAH LIPPITT: Yeah, change does take quite a while in the industry due to its conservative nature. Now, moving on to awareness raising: what other kinds of solutions

are out there to help people learn more about the industry? Monica.

MONICA CUITIVA: There are a lot of trainings out there. And for Latinos in Clinical Research, that's part of our mission, right, to educate people. So, what we're doing is we're educating people in different levels. Like, for example, for people that want to know overall about the industry, we have webinars monthly, then we also offer classes, and this we do it through the University of Clinical Research in which we have different classes for different areas. This is starting from the grassroots, like for example, the clinical research assistant and then going to the clinical research coordinator, the clinical research associate,

then for clinicians, for medical writers, for data management. So, we're trying to educate in different levels for people that are just entering the industry and want to have a solid foundation to start a new career or for people that are already in the industry that want to advance into a different position.

HANNAH LIPPITT: And Judy, from the site owner

perspective, do you have any thoughts about the training options available?

JUDY GALINDO: So, I'm excited. You know, everything that Monica described helps me

as a site owner, bring on new people to start with this, because I can use all those different resources that we have to get my staff trained and then it's less time internally that we have to spend on training them because these didn't exist, these are recent, the past several years, but I've been in the industry for 18 years and we didn't have all this training 18 years ago.

So, it is challenging bringing on new people to say who don't have any research experience. And internally a lot of us have to create these trainings that we have that are specific to our sites. But I always like to supplement those internal trainings with other trainings that exist in the industry that can bring on this person faster to start with.

HANNAH LIPPITT: And going back to the topic of hiring people who are new to the industry, how has this gone for you?

JUDY GALINDO: In my community, when I hire people, there's nobody with clinical research background. So I do take a chance on new recruits. I hire people with a psychology background, medical system background, phlebotomy background – at least they have that part of it – and it's easier to train on the clinical research aspects. So, most of everyone who got started with us at our research center didn't know anything, and they were trained internally and have been with us several years. I have a lot of new people that started recently and this is the process we have gone through. So, like I had mentioned, I'm excited that these academies and different trainings exist now because it makes my job easier and I think a lot of other research centers and other companies should take a chance like that and bring on people. And it is a grassroot effort. You actually have to sit with them and, you know, go from the beginning: “What is clinical research?” It's a lot of work, but once you go and you train that person, a lot of these people are very dedicated and will stay with you for several years.

HANNAH LIPPITT: As a site owner what types of training do you feel are most effective?

JUDY GALINDO: Online trainings are excellent, but also exposure, hands-on exposure, shadowing coordinators, research assistants, various other positions within, that's the training that's required to bring these people on – it's a combination of both. And I think sometimes we forget, because we're so, you know, the past couple of years, everything's been online, electronic, remote, but that person-to-person, as we had mentioned, grassroots effort, that's part of the grassroots effort of actually having them come into your site and do internships, you know, offering, opening your site to bring on these students who have completed this programs and actually giving them the opportunity to have a hands-on learning experience.

HANNAH LIPPITT: Could you explain more about what specific issues face the Latino community when it comes to clinical research, recruitment and knowledge? Monica.

MONICA CUITIVA: In

our community, in the Hispanic community or Latino community, I think that the biggest challenge is that we don't have much material or is also lack of awareness about clinical research. And this is obviously doesn't give people the comfort to be part because they still scared of the industry or they still scared of pharmaceutical. It is important to educate them, it is important to inform. It is also important that the sponsors, the CROs and the sites work together, creating material that educate this population.

I think on this site level we do a lot of work about it,

but we need to sponsor and the CROs to support in that area. Even the FDA now has the guidelines for diversity and have more requirements and is pushing the diversity part. Oftentimes you see studies in which you are not given material in different language rather than English. So that makes it more difficult for sites

to reach out to these specific communities. Like, for example, in our cases like Judy and the sites, our sites are located in a high population of Latino communities, we have that difficulty because the material is not really available, and obviously there are no match sites or a lot of professionals like doctors or clinicians that speak the language at the same time. So the education part is really, really important.

JUDY GALINDO: The lack of awareness, lack of materials, that's a huge barrier. It puts us behind on recruitment if we can't recruit Spanish speakers. And sometimes occurs and months and months later, we get the Spanish material. But the other issue in my community – it's about 80% Latinos – is the lack of education of clinicians who don't know about research. They never worked in it. They never participated. So they don't talk about clinical research studies to their patients. And so this is where we need the sponsor, CROs, vendors – everybody else in the industry – to assist sites in these communities, to educate these doctors, to let them know that there's clinical research studies going on in the community. We're doing it at the site level, but we need more support for that.

HANNAH LIPPITT: Looking to the future, how do you see the industry shaping up when it comes to addressing the issue of workforce shortages over the next few years? Monica.

MONICA CUITIVA: I have seen many organizations that right now are doing some trainings and trying to bring more of this diverse group of professionals. However, I think we all need to walk the talk because the majority of organizations are talking about this, but very few of them are really doing it. I see the company is doing it like Judy was saying it before. I see the companies doing it slowly – they will get there – but at this point where we are and we need the industry to move faster and this is also to be reflected in the products that we're bringing to the ward, right? Like, the new treatments and the new generation of drugs and equipment. So, I see a bright outlook, I see good opportunities out there. But again, the companies and we all at the same time need to walk the talk.

HANNAH LIPPITT: And Judy?

JUDY GALINDO: I do see a lot of positive change happening already. There's been a lot of discussion the past couple of years. There's a lot of organizations that are doing great things already. And I think collaborating is one of the things that maybe we need to do more of in this industry. I don't see a lot of that happening. Everyone's kind of doing their own thing, but maybe if there's a way we can come together and how can we work with each other to address the issues we have in this workforce to improve it. But I do see some change already happening, and it's going to take all of us to change this, to address these issues, not just one organization, not just one company or one site, but I think if we're all aware of that and we each contribute and do something to change this, we'll see a significant impact on the workforce and more people entering it who have never heard about clinical research hopefully in the next several years.

HANNAH LIPPITT: Well said, we all need to work together to improve the situation. Thank you so much to both of you for taking part in the Totally Clinical podcast. Now, to learn more about Monica and Judy’s work, listeners can visit LatinosInClinicalResearch.com and UniversityOfMedicalResearch.com. You can also connect with Monica Cuitiva and Julie Galindo on LinkedIn if you’d like to reach out directly.

HANNAH LIPPITT: And that's your dose of Totally Clinical. You can download our podcast on Apple, Spotify and Google. Please subscribe and leave a rating and review so more people can find the show. See you on your next visit and remember to bring your friends. Thanks for listening! Goodbye!

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HANNAH LIPPITT: 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.

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HANNAH LIPPITT: So,

this week I am joined by two – yes, two – of team Teckro, or Teckronauts, to talk about the crucial role of clinical research associates in clinical trials. Now CRAs can often be overlooked, yet they keep the show going in so many ways, so it's really important their pain points are highlighted so processes can be improved and technology utilized to help make their lives easier. So without further ado, welcome Silvina Baudino and Maria Milas to the Totally Clinical podcast. Now both of you have already been on the podcast separately before, so it's really exciting to have you both here at the same time. Could you start by giving the listeners a quick reminder of your backgrounds and roles at Teckro starting with you, Silvina?

SILVINA BAUDINO: Yes, of course. Thanks, Hannah. So I started working in clinical research more than 20 years ago – a long time – as a Study Coordinator and later moving into the sponsor side for my first and then see roles with different roles that ranged from clinical operations to strategy until I joined Teckro less than a year ago to lead our site engagement strategy.

HANNAH LIPPITT: And you, Maria?

MARIA MILAS: So I started in clinical research as a CTA. So that's somebody who assists the CRAs, right – the monitors – in helping with documentation in the clinical trials such as well, keeping track of the documentation that's coming in, filing it in the eTMF, maybe keeping a QC of the eTMF and also helping the manager with the site.

After some time as a CTA, I changed into a CRA position for which I stayed for over five years. And then after my period of over five years as a CRA, I joined Teckro, and I joined Teckro as a solution consultant, and I am part of the sales team, and what we do, basically, is try to understand what our customers or prospective customers' needs and challenges

are. And with that in mind, we try to deliver customized demos of our technical product.

HANNAH LIPPITT: If we think about the role of a CRA, this kind of pivotal person who needs to be able to adapt quickly to different situations, as somebody with a background, as a CRA, could you explain your working relationship with other site members?

MARIA MILAS: CRAs’ main point of contact as a site is usually the Study Coordinator, so it is true that officially the Principal Investigator is the main responsible for the site and the site activities. But in real life, the PI is just the person who might put his or her signature on the documents and sees patients and delivers treatment to the patients.

But if we are honest, let's say in real life, all activities are performed or if not fully performed, they are at least prepped for follow-up by the Study Coordinator, and that's why the relationship between the Study Coordinator and CRAs can become very close. And let me give you an example of this close relationship. So the first thing I would do when I go on site for a monitoring visit is to grab a quick coffee with my Study Coordinator and catch up. Know what's been going on. Know how the study is doing. How is the relationship with the Principal Investigator? All those things that are more on the daily basis of the clinical trial. And then during the monitoring visit most of the time I spend this with my Study Coordinator, right? So, asking questions, reviewing discrepancies together, sitting together... basically for most of the day. And that turns the CRA and the Study Coordinator relationship

into a very close one and definitely a very important one down the road in the clinical trial.

HANNAH LIPPITT: Silvina, do you have any thoughts on what Maria just discussed?

SILVINA BAUDINO: I fully agree with Maria. It doesn't matter if the clinical trial, you know, is traditional or hybrid or decentralized. That relationship is crucial. That was my experience when I worked as a Study Coordinator many, many years ago, and I have worked with many different CRAs. Some of them were great, and some of them – to be honest – were challenging. I think that really a good understanding, transparency and collaboration are the pillars of that relationship.

Even when my experience, as I said, was a long time ago, when I speak with different sites and Study Coordinators right now, they feel that those principles are still relevant and timeless. As we know, things are getting more complicated. Trials are more complex, and there is additional burden just for not only for CRAs, also for the sites to deal with more technology, there is extra pressure. So, I think it's very important to help these people to alleviate their burdens so they can keep that relationship solid and transparent as it should be.

This is one of the reasons why I joined Teckro because I think it's very important to provide Study Coordinators, CRAs and any clinical research stakeholder tools to keep those relationships as the base of the good understanding and the success of clinical trials. Just to give you an example, my best friend used to be a CRA when I was a Study Coordinator

more than 20 years ago. That is the kind of relationship you sometimes have with your CRAs.

HANNAH LIPPITT: Oh, wow. And do you have any stories about the more difficult CRAs?

SILVINA BAUDINO: I think that trust is the base not just, you know, for any CRA and Study Coordinator relationship. It’s the base of any kind of relationship you have as a human being. I think that sometimes it takes time to build trust and some people have problems with trust, but it doesn't matter. So, you always have to

be professional and to deliver what you are supposed to deliver. But I must say that I enjoy some of the CRAs’ visit, and some of them were not that pleasant.

MARIA MILAS: Those are done by the CRAs who have the most number of monitoring visits per month, right?

SILVINA BAUDINO: Yeah!

HANNAH LIPPITT: If we think about recruitment, that's an aspect of a trial that's really challenging and sites struggle to find patients and sponsors want faster enrollment, and then you've got the CRA stuck in the middle. And this can be really time-consuming. Maria, can you expand on this and talk through some of your pain points when it comes to enrolling when you were a CRA?

MARIA MILAS: Oh Yeah Hannah, I think you definitely identified the biggest challenge in clinical trials: recruitment. So, recruitment, as you just said, is a huge, challenging moment in the clinical trial. So, on one side, you have the sites who are struggling to find patients and then on the other side, you have the sponsor who usually is pushing for a faster enrollment, and then you have the CRA who's somewhere sitting in between those two roles.

Now what this situation translates into is that the sponsor is constantly going to ask the CRA, “How is the site going? Do they have any candidates in mind? When are they going to consent that patient for which we were discussing about?”, and all these questions are going to get to the CRA and the CRA will pick the phone and call the Study Coordinator because the Study Coordinator will be the person who will have the answer to those questions, right? So that means time. It's time that we are taking

from our site staff to actually look for patients and actually enroll those patients and those candidates. And there has to be a better way, a more optimized way, right, to allow our sites up to have more time to tackle this extremely challenging moment in clinical trials.

HANNAH LIPPITT: And Silvina, if we think about much of the work you've done with sites, you'll really understand just how important communication is as one of the key problems that needs to be solved. It's like everything, like with many things in life, everything comes back to communication.

SILVINA BAUDINO: Sponsors are very eager to, you know, to reach their milestones, and sites feel the pressure to deliver what they have promised before. And obviously, because you are starting a new process – you are executing a clinical trial – is the time when you tend to make more mistakes because it's something new. So that adds a lot of pressure to the relationship between the CRA and the Study Coordinator. Not among them, but because the CRA feels the pressure from the sponsor and the Study Coordinator, sometimes from the Investigator and the rest of the study team. So I think that it's very important that... try to keep calm. It's almost impossible, but really stay focused on, you know, each step and it's a goal that is shared between the sponsor and obviously at the site because at the end of the day, we all care about patients. So this is one.

I think the relationship is put really under everybody's eyes and it's important to, because it's when you start building

trust, right? If you can overcome that very difficult moment, this really sets the tone for the rest of the relationship along the trial. So, it's very important that we need to help everybody to make this situation easier and provided to really keep that relationship solid.

HANNAH LIPPITT: Maria, do you have any more examples of communication problems you've experienced?

MARIA MILAS: I was traveling to a site in Spain for a monitoring visit. I was on a flight and when I landed, I had 16 – yes, 16 – missed calls from one of my Study Coordinators. And whenever that happens, a monitor knows that something bad happened, or at least something went wrong, right? And at that moment, you basically think of 10 different scenarios of what could have gone wrong. So I landed from my flight, I called my Study Coordinator, my Study Coordinator didn't pick up the phone at that time, and I tried calling – of course – several times during the morning and when finally we could talk, there was a frustrated Study Coordinator on the line telling me that a biological sample was lost, because they didn't know what kits to use to ship that sample to the lab.

And how can that happen? How is it possible that because we didn't have that direct line for communication, we lost a patient biological sample?

HANNAH LIPPITT: Hmmm.

MARIA MILAS: Imagine that situation.

HANNAH LIPPITT: Yeah, it must be like, your heart skips a beat!

MARIA MILAS: Definitely!

HANNAH LIPPITT: It's so interesting to think about why trials are run in the way they are. Mistakes like this happen. Real problems, and why they've been so slow to adapt. Do you have any thoughts on this, Silvina?

SILVINA BAUDINO: If I look back when I started – like ages ago – now, changes are going at a faster pace than they used to be. To give you an example: to move from paper case reports or forms that everybody knows is CRFs to electronic data capture systems like EDC took more than a decade. Yes, 10 years to adjust, you know, and I was told that there are still few studies out there that are using paper, believe it or not. But when we think about now... paper and fax really sound very obsolete. But that was the first big step in terms of technology adoption for me compared to what we see right now. Now, many processes had to be adjusted because there is a new reality. Remember, at that time, we didn't have tablets or smartphones or all the digital systems we have right now, and we need to change the way, how we capture information and how we communicate to each other, right?

So, all these changes which experienced really an extra push of acceleration with COVID, can be overwhelming. Not just for CRAs – for sponsors in general, for sites and also for patients. And in the middle of this change, the changing times, it’s not a secret that protocols are becoming more complex and the evolution of the protocol design is not moving at the same pace that technology is moving.

So there is this connection there because protocol design is changing at a slower pace and technology is coming. Currently, as you know, everybody is talking about patient inclusion and diversity. This is the real hot topic in clinical research, but these two changes need to go at the same speed. I think that is really what we need to make the big change that is needed still in clinical research.

MARIA MILAS: I definitely agree with you like that. The biggest thing I can see that has changed during my – let's say, not that long – experience in clinical trials, but to technology definitely has made a great impact in clinical trials. And it's definitely a great thing because it helps the Study Coordinators, it helps the investigators. It helps not deal with so much paper. It helps the environment, even, right? But in the end, what we see nowadays is that our investigators or Study Coordinators end up with so many credentials, with so many tools, with so many websites that they have to log into with so many applications, that sometimes it's very difficult for them to actually remember which one to access at each specific clinical trial and for each specific patient visit.

Technology is definitely helping the clinical trials to evolve and to develop faster, but for now, we're still, let's say, having that burden of having too many vendors or too many credentials or too many things to keep in mind still. And then on the other side, I would also say that because clinical trials is a huge field that's being developed in the last few years, our investigators and our sites have a significant amount of clinical trials at the same

time, right? So, running at the same time, that means that you will have a very large number of people – of roles – involved at the same time, and it's difficult for our investigators to keep track of, “Oh, who's this CRA on this trial? Who’s my sponsor contact on this trial? Who is my Study Coordinator or my pharmacist for this trial and the one that I'm having a patient visit tomorrow?” right? So there's still, I would say, we still need to figure out how we're going to take some burden out of our investigators.

HANNAH LIPPITT:

It's interesting, actually. I was speaking to somebody the other day who was talking about investigators and how often they just want to do one trial and then they don't want to do any more. So yeah, it's – a real problem.

MARIA MILAS: It's a burden for them, I would say their main objective is still the patient care, right? So, if we add on top of that and it becomes more difficult and it becomes a burden for them, some investigators will opt to just stick to the patient care.

HANNAH LIPPITT: It's interesting to think about the future as well and the direction clinical trials will take in the next couple of years. We've obviously just been through a difficult couple of years with COVID, and lots of changes have come into force. I think I've spoken to both about this before, but do you have any other thoughts on how CRAs will need to adapt Maria?

MARIA MILAS: As a CRA we're going to go into more offsite activities, so maybe even more site management from home or even more monitoring visits from home. But definitely as a CRA, I believe that... you will need to have as much communication happening with your sites as possible. Because slowly and slowly, we're going to go less on sites, right? And that human interaction is going to be needed to still have an idea of what's happening and to give support to your study, to your site, as much as they need

it, right? So, we definitely are going to adapt to it. See how we adapt. Maybe we're going to have one tool that will provide us with all – everything – we need to run the clinical trial. So ideally, that's what the series will help, right? One single tool for the clinical trials, and they can do all the activities through there, all the communication, all the side management, all the monitoring, but it's definitely going to be less on-site monitoring visits and activity.

HANNAH LIPPITT: Silvina, do you have any thoughts on this topic?

SILVINA BAUDINO: Everything goes back to communication, right? And it's challenging to build a trust and that relationship in a remote way. Not everybody feels comfortable working remotely, and I agree with Maria. We will see more like remote visits versus in-person. But there are a lot of things that are still to be seen, because if we talk with different sites and sponsors, it seems that the model that we will see more in the future will be hybrid. And I think that this is something that has to change to engage more physicians to continue working on clinical trials, and not just one time, as you mentioned, Hannah, because that is the only way we can engage more patients, have a more diverse patient population and provide access to clinical trials to more patients, is to have more physicians involved.

And I think that in addition to technology, it should be more friendly and really helping sites and CRAs and not being like... you're making the stakeholders feel like extra burden and should be, right, a tool. I think that in addition to that, we need to see a change in the protocol design that should be more flexible. This is what I see. I foresee for the future. I know that some sponsors are asking patient advocacy groups and sites to provide feedback about the design and early stage, and this is what we need more and more, so protocols can really be executed in real life and not like something that isn't completely out of reality.

And the other piece really is to give more flexibility to patients. I know that as you mentioned during these last two years, things have been very, very difficult because of COVID. But some patients don't feel comfortable doing everything remotely.

They want to go and see in person. Their providers, their Study Coordinator, their physicians. They feel that their care is different and we need to respect that. So what I foresee for the future is that some of the protocol visitors clinical trial visits will be more flexible, and the patient could make a choice to do the visit in person or remotely or in different ways. I think that is the future, more flexibility – that at the end of the day, this is what will improve communication.

HANNAH LIPPITT: Thank you so much, both of you, for coming onto the podcast, and it's been a great conversation.

SILVINA BAUDINO: Thank you.

MARIA MILAS: Thank you Hannah, great to be here. Just as a thought to, you know, bring home with us... the clinical trial’s main purpose is to bring treatment options to patients, right? Sometimes it's even for patients who have no other treatment options in the market. Maybe somehow, let's just think each one of us of how we can take some burden out of our investigators, so that they can focus, and so that they can have more time to actually make it happen, right? Make those patients have an option to treatment.

SILVINA BAUDINO: I fully agree, and this is the reason why now I am full circle. I started at the site, then I moved to

pharmaceutical company to a CRO and now I am like part of Teckro – it’s a vendor – to be part of that future because still there are like many things that are broken in the system and we are helping or trying to help, to repair or to provide additional tools. I think that we always said: “Make things more simple.” It's not just about acceleration, it's about simplicity, too.

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HANNAH LIPPITT: And that's your dose of Totally Clinical. You can download our podcast on Apple, Spotify and Google. Please subscribe and leave a rating and review. So more people can find the show. See you on your next visit and remember to bring your friends. Thanks for listening! Goodbye!

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