Hello everyone, welcome to Clinical Trials Digital Week, brought to you by the organizers of the Global Clinical Trials Event and Content Series. My name is Joanne Driscoll, I'll be your host for today's session, titled "The Impact of COVID-19 Pandemic on Early Phase Clinical Trials." First, I'd like to cover some quick housekeeping items. If you experience difficulties with audio or advancing slides, refresh your screen with F5. If you're experiencing any other issues, hit the question mark button to receive assistance. At any time during the presentation, you can submit your questions into the Q&A window on the left-hand side of your screen. In 24 hours, you'll receive a link to watch the recording of this session. You can also download a few featured articles in the resource list box on the right-hand side of your screen.
Let's now begin by introducing our speakers for the session from SGS Health Science: Katrien Lemmens, Medical Director, and Martha Hyland, Senior Clinical Project Manager. Thank you for joining us today, Katrien and Martha. Now I'll hand it over to you to begin the presentation.
Thank you, Joanne. It's a pleasure that we can share here today how we managed our early phase clinical trials in our phase I unit in Belgium in the past year during the pandemic. I'm indeed Katrien Lemmens, and I'm the Medical Director of phase I unit of SGS located in Belgium. I will cover the first part on the operational challenges we faced in the unit, and then I will hand over to my colleague Martha, who will talk about monitoring in these times. I think a lot of us still vividly remember how the pandemic hit the first time, and at least I do, because in Belgium it was Friday the 13th when all of a sudden I was stuck at home with three teenagers because the schools closed, and then measures were taken very rapidly, and actually on the 18th of March we were in a lockdown.
This lockdown actually meant that all non-essential displacement was not allowed anymore, everything was closed, you had to stay at home like in all countries globally. So for the clinical trials, of course, that meant that, yeah, we had to find a way around that as well and what to do. So FDA and EMA and also our Belgian authorities came with guidance. Straightforward, of course, but for us a challenge to implement that absolute priority needed to be given to COVID trials and that the feasibility and the necessity, especially of starting any new clinical trials, should be assessed. And of course, everything should be postponed like on-site monitoring, what Martha will be talking about if possible.
For us as a phase I unit, that meant putting on hold all recruitment of new trials, but also cohorts within ongoing trials, and only, yeah, going down to the essentials and doing follow-up for safety, but nothing more than that. Everything was put on hold, and we can actually say that we then closed our CPU. But what happened since then? A full year has gone by, and this is the timelines of the waves in Belgium, and I think they are similar with some slight delays or being ahead compared to other countries. The lockdown was roughly two months, and then the hospital admissions were lowering, so we could reopen, and I will talk about that in an upcoming slide on how to prepare for the reopening and how to do that.
But then, as you can see in the year ahead, the pandemic wasn't gone after that first wave. That's clear now, and so we had to prepare for a second wave, which in Belgium hit around November, and PCR testing was a very important aspect of that in the community, but also for us within the unit, and I will give some details on that in this presentation as well, and then there is, luckily, the vaccination that started I was at the beginning of, well, actually end of 2020, but came at full speed in 2021, which is also influencing or something to take into account in phase I trials that we do, so first of all, the reopening. We had, of course, to align with our authorities in Belgium, but also within the hospital.
We are located in an emergency hospital because we are a phase I unit, and so, of course, need to see that within this pandemic the hospital could do their job, which was a priority, of course, and had to align with them very carefully, and all this on this slide makes sense and is what we had to do in the community, as each one of us and for every business, but a bit of a challenge in a phase I unit, of course, that you want to avoid the spread of SARS-CoV, first of all, because of the safety of your participants, but also your staff, but also the data quality, because, of course, people getting ill may influence the ease you are recording in first units. The way we did it was, of course, with all hygienic and preventative measures: alcohol gels, distancing.
We all know it by now by heart. It's becoming a commodity, but from an organizational point of view, that had some impact. We had to reorganize our screening, people coming one by one, for example, with separate appointments. You can't invite groups for a screening for that one. Also, for ambulatory visits, we needed to spread them in time. Our wards are reorganized, that beds are separated, and also admissions are separated in time, so volunteers come on time slots that are separate from each other, also to avoid that people are meeting each other in the corridors and in the hallways.
That's for the trial itself on an operational level, but also the monitoring, and that's what Martha will give examples on how to organize that, because not only for the volunteers, but also for staff, we wanted to have as few people on the floor as possible. It may be a bit contradictory that you can do first in human trials with staff working home-based, but I will show you that even my medics could do that, and are still doing that, working part-time from home, and never the full group is in the unit. Only the people are there who need to be there and for the safety of the volunteers, but we have an e eSource system, and we can work from home as well, so I will give that as an example.
A very important tool in all of this is PCR testing, and I will go into detail in the further slides. This is how the unit now still looks like, and I think the pictures are similar to other companies where chairs have been taken away or are crossed because you can't sit there. There are one-direction corridors. There are shelves everywhere, so that has become our new normal. This is the eSource system I've been talking about, and it was a big advantage that we already used that for years. We used the new ones in last year, but we have used eSources for many, many years.
So the staff is used to working as such, and as it is cloud-based, we can access it everywhere, meaning that my physicians can follow up on AEs, can follow up labs, ECG tracings, everything from wherever they are, meaning that they only come to the unit for operational tasks. Of course, there is a physician available for safety when volunteers are in-house, but other things can be done home-based. And then there's the PCR testing, a very, very important tool that we still use on a continuous basis. Of note, and I think most people are aware that there's two sorts of testing.
You have the PCR testing, but there's also rapid antigen testing nowadays, and what we use in the unit is the PCR testing, although we have rapid antigen tests in-house as well, but these have less sensitivity, and we only have them as a backup in case a kind of outbreak or a cluster would happen. The definition of that is two cases that can be linked, for example, to volunteers in the same ward. Luckily, we didn't have that yet. So here are some numbers on how indeed PCR testing was very important in the community as well. So the difference in the first wave was that we didn't know it was coming. We didn't know it was happening. We only had the hospital admissions, which was actually the tip of the iceberg.
Then, over summertime, contact tracing and PCR testing was rolled out in large amounts in all countries, so also in Belgium, and then we could better predict what was coming, and you see that the daily new cases and the hospital admissions are aligned, and that is exactly the same in our unit. So it's actually the positivity rate that is important to follow, and if you test a lot, you have a better idea of what's going on under the surface. So here are some numbers of our unit. I must say numbers are from until the beginning of May because, of course, I had to make the presentation, and they are evolving on a daily basis, but luckily not the percentages of positive cases.
So we test upon every admission, meaning that when a volunteer needs to come to the unit and stay in the unit for a couple of days, which is always the case in a phase I trial, at least for one or two overnight stays, then they get a PCR test, and they can only be admitted to the ward if the test is negative. Of course, if they are in the unit during their stay, if there's any suspicion of an infection, and in wintertime you have all sorts of viral infections, they are tested as well.
Importantly, a decision flow, very descriptive, is present in the ward so that all staff always can check on the decision chart what to do, and of course, it always involves calling the physician, but they have to isolate the subject if there are suspicions of infection and so on, and that's all written down in a very clear and simple way. We screened a lot of volunteers in the past year and dosed many of them, and as you see, our positivity rate, and if you remember the slide before, we peaked in November as high as 30%, and now are around 3%, but have been around 5% to 6% for a long time, and we managed to always stay below 1% in our unit. An important aspect to evaluate the impact on the trials is when it occurs in a trial.
Now, first on the left side, I think if you see per month the cases that we have, it really reflects what was going on in our surroundings, in the community. I said that in Belgium we had a peak with a positivity rate near 30% around November, and we see that we tested more volunteers positively in that period. But luckily, the 10 that had a positive test were before dosing, so as set upon admission, and they could be replaced by reserve subjects that we always have in our type of trials and were not admitted to the ward, which is a very important preventive measure, of course. We only had one volunteer during admission, could be sent home after a safety evaluation, and all the other volunteers and staff that had been in contact were tested, and no one else was positive.
Apart from that, the other nearly half of the positive cases are doing follow-up when the volunteers are not in the unit but only coming for ambulatory visits, and of course are then prohibited to enter the unit, and we follow up remotely. Also, our staff needs to be tested, and here is the amount of tests that we perform per month. We have a script in our risk mitigation plan for that as well, and it, of course, always goes via me and my medical team to check when a request comes in if someone needs to be tested, and that is mainly, as you see on the right side, because they had a contact, a contact normally at home, because there are no high-risk contacts in the unit. We all wear masks and keep distance, but even if a contact was intermediate risk, as to say, we tested.
I must say we tested very, very liberally in order to avoid any risk, and you see here again that it overlaps with what happened around us again, October-November. We had to test quite some personnel, and again we had a smaller bump peak around the Easter period, March, beginning of April, and also then we had to test more personnel. But importantly, none of those tests were positive. That doesn't mean we didn't have any positive personnel, but just a few, luckily. Those were tested externally, could be put in isolation immediately. We did then our own tracing within the unit, tested colleagues if we deemed it needed, and as such could keep COVID out of the unit also in terms of our personnel.
So that's for the COVID cases we had and the way we managed to keep it out of the unit, and fingers crossed I hope we've seen the worst of it by now. That brings me to a second aspect, and that is the vaccination. The vaccination campaign is going rapidly, so again, apologies that my numbers are already outdated. I looked it up this morning, and we are rapidly increasing with first coverage, especially in the population around 40, which is now already 67%, so it's going fast and luckily so. But what does that mean for our trials?
Sometimes in first-in-human trials and early-phase trials, vaccination is not allowed during the trial, and so we have to look at the timing of the vaccination campaign because it speaks for itself that as medics, we see it our ethical obligation to tell people to go and have their vaccine, and that it always is a priority above entering a trial, and the population that we typically have in our trials are the healthy people above 18, so unless they work in healthcare or in other essential sectors, they don't fit into the category of 65-plus or comorbidities, so meaning that we have to check whether vaccination is allowed or not allowed, and how does that affect participation? We did the exercise a time ago, but so numbers may have changed a little bit, but the percentages remain the same.
Luckily, in a lot of trials, vaccination was allowed, and if it wasn't, it was after discussion. And the gray zone, one in three, we still need this discussion for trials that are planned at the moment or will be planned in the years to come. Needless to say that it's one of the criteria that we carefully look at, as it would be a no-go for us if it's not in alignment with the vaccination campaign. Then, to do so, it's important to check why it's not allowed because sometimes that can help in negotiating a little bit. And if there's no reason or just because it's in the template, I must say that we then argue very hard. And that's a large amount of trials that we still manage to have a window that it would be allowed.
But of course, for other vaccine trials, the endpoint would be influenced, so we can appreciate that that is not possible, and also other types of infectious challenge trials that we did. It was not allowed. Another important reason why vaccination cannot be allowed is when the IMP may reduce the efficacy of a vaccine, for example, due to an immune suppressive effect, and we do have four of these types of trials, so there we carefully need to evaluate the timing of the trial. And that you see here, when is the vaccination not allowed? Is it during the entire trial or just a certain period? And how does that relate to, and that's the table on the right side, how does that relate to the vaccination period in our country?
And doing this exercise, it's just for two trials that will start up still in August-September and will not allow the vaccination during the entire trial that we need from an ethical point of view to decide to only enroll subjects that are already fully vaccinated because the trial is like two months, and the volunteers will fall outside of the window they get their appointment, and that is ethically not okay. But apart from those two trials that we have to manage the recruitment, for the other ones we could mitigate, but it is a very important exercise to do.
And then I want to end up with the vaccination status of our volunteers, but it might be outdated already as we go fast. But when we did the survey, three out of four were not vaccinated yet and were planning to get a vaccine, but then, and that's a bit surprising so, and there should be another yellow bar, sorry for that, that one in four is still doubting or doesn't know whether they would get a vaccine if they get an appointment. And the reason that they are doubting is because they are a bit afraid of side effects and think that development went too fast, and I find that quite surprising because this is a population of healthy volunteers that are used to participate in first-in-human trials, which are, I think, considered in the community as being a bit risky and side effects that are not known.
So I think here we have a responsibility to check the communication in the media and see to the misinformation that may be existing there. So with that, I want to wrap up my part that I showed how we had to manage everything last year from reopening and beyond with our risk mitigation strategy in which PCR testing was key, and that we are still managing to work around with the COVID vaccination. And with that, I'm glad to hand over to Martha to further discuss how we did the remote monitoring within SGS.
Yes, thank you, Katrien. So indeed, with this final topic, remote monitoring, I will start my part of the presentation, which will be discussing actually or presenting the impact that the COVID pandemic had on the monitoring activities of the SGS Clinical Operations Department.
So before continuing, this first part of the presentation presented by Katrien was indeed focusing on the SGS Clinical Operations Unit. However, at the SGS Clinical Operations Department, we do the monitoring of both the CPU studies but also the non-CPU studies. So at the time indeed that we were facing with the COVID pandemic, the regulators published some expectations, so FDA and the EMA published some recommendations specific for the monitoring activities in clinical trials. So I will not go to all those recommendations published by the regulators, but I just want to highlight here today for you four ones which are also important for the rest of my presentation. So one of the recommendations was that for the monitoring activities of studies that were affected by the COVID pandemic, that actually those monitoring activities needed to be reassessed.
And basically, the recommendation was that actually those monitoring activities that were really essential, those activities had to be performed. Of course, highlighting that the quality of and ensuring that the quality of the clinical trial data would be guaranteed at all times, and that also the rights, the safety, and the well-being of the participants would be protected indeed at all times. Another recommendation from the FDA and the EMA was indeed that when indeed the monitoring strategy would be adapted in the clinical trials, then this for sure needed to be documented and reported somewhere so that it could be tracked also afterwards. A third recommendation that I wanted to highlight for you today is that robust follow-up measures and catch-up activities needed to be planned and needed to be ready to be implemented once the situation got back to normal. So that was the third recommendation.
And then the fourth recommendation was in situations indeed where on-site monitoring could not be performed anymore. In those situations, for those sites, actually the option and the programs to do some remote monitoring should be explored, if feasible and allowed, of course, and also taking the extra burden for the site into account as adjusted by the principal investigator. In case the source data verification, for example, should shift from being performed on-site to being performed remote, then also this needed to be described in the protocol and in the ICF, and also subjects needed to be aware of this shift in monitoring activity. In the next couple of slides, I'm going to show you actually how SGS Clinical Operations Department has implemented these recommendations in their monitoring activities.
So when going actually for the first recommendation, adjusting the monitoring strategies, finding the right balance between decreasing the on-site monitoring activities but trying to increase the remote monitoring activities, this was actually a challenging exercise because we were faced with the difficulty that for certain sites, some of the aspects, some of the monitoring activities just could not be performed on a remote basis. For example, this was applicable for sites where, for example, they were using a paper investigator site file, or for sites, for example, where SDR and SDV could not be organized in a remote way and still needed to be checked on-site. Also, for example, sites where indeed the drug accountability also was performed on paper, there also for those kinds of activities, our monitors needed to be on-site.
Then, on the other hand, we tried to implement the remote activities for the monitors as much as possible. We got in dialogue, of course, with the sites, with the applicable sites to come up actually with a solution. So, for example, and to see if the sites indeed were available and were open to, for example, organize video reviews of the medical records, or, for example, to share pseudonymized copies of source data via a secured environment with our monitors, or, for example, if there would be a possibility for our monitors to get access to the electronic medical records. So, as mentioned, really finding this balance between reducing on-site activities and increasing the remote activities was a difficult exercise.
With this slide, I wanted to come back more specifically on our monitoring activities on our SGS Clinical Pharmacology Unit studies, so the CPU studies, because as already highlighted by my colleague Katrien, the SGS CPU is using an eSource system, and our monitors are doing their monitoring activities through their eSource system, meaning actually that they do as much as possible already through remote SDV and source data review. So, actually, with the eSource system in place already for a long time, the SGS Clinical Operations Department was actually already in line with the guidelines from the regulators, the guidelines saying that SDV, SDR needed to be performed as much as possible on a remote way. Actually, we were already in line with this guideline before this guideline was published by the regulators.
To come back or to go into a little bit more detail related to monitoring via the eSources, it's a secured way actually to do remote SDV and SDR, and the system is built as such that it protects the privacy of our subjects at all times. You can only get access to the eSource system or to the study in the eSource system by going to a secured application or to a secured website where you need to log in with your login details. Really, the access is being managed by the CPU itself. And as mentioned, the system, the eSource system, is built in such a way that to avoid really the personal data breaches and accidental data disclosures, which, of course, is a risk when we would go for remote SDV or SDR through sharing pseudonymized copies via a secured environment.
So, by using the eSource system for doing our monitoring activities at the SGS CPU sites, we could actually, during the COVID pandemic, continue as almost being normal with our monitoring activities, ensuring the subject safety and the data integrity when, at that time, during the COVID pandemic, the CRAs were not allowed to go on-site. I mentioned almost normal monitoring activities as also, of course, our CPU unit still generates some, although very limited, but still generates some paper source. So, also for checking the paper source or, for example, the paper investigator site file, for that actually we needed to come up with a solution to do it on-site. So, again, going back to implement really the recommendations from the regulators, and one of the first recommendations was really to adapt the monitoring strategy for the studies that were affected by the COVID pandemic.
For the on-site monitoring activities, so also for us, for SGS Clinical Operations, we had to cancel some of our on-site monitoring activities that were scheduled or postponed to a later time point. As mentioned, we really needed also to take the guidelines from the regulators into account, and also in order to go on-site, of course, we needed to get the agreement from the site itself. We really needed to have a written approval that our CRAs could travel to that site. Related to the monitoring activities at the SGS Clinical Operations Department, we really tried to increase the remote data review as much as possible. And also tried for the sites, of course, that are not using the eSource system. We also tried to implement a remote way to do the source data verification as possible.
Also, very important for our CRAs was to stay in touch with the site because for studies where the activities just continued during the COVID pandemic, it was important that the CRA got in contact with the site asking indeed how things were going, if there were any issues, and so on, because monitoring activities were reduced, so staying in touch through other channels was also key in this situation. Another recommendation, as mentioned, was to document everything and also to implement some tracking tools to see actually how the COVID pandemic affected the studies but also affected the monitoring activities, so for some of our studies where we did the monitoring activities, we implemented protocol amendments, and we saw indeed that sections related, for example, to withdrawal of criteria, eligibility criteria, and visit schedules.
Those were mainly the sections for which we needed to amend the protocol in order for the study to continue during the COVID pandemic. We also used our clinical trial management system, so the CTMS system, to track really the impact of the COVID pandemic on the studies. We implemented in that system checkboxes which needed to be checked indeed to highlight on a particular study if it was indeed affected by the COVID, yes or no, and on which level. Was it, for example, affected on study level only or really on country level and site level as well? The information that was put in the CTMS system via those checkboxes was also imported into the visit reports that our CRAs were creating.
That information was already visible in the reports, and also, in addition to that, it was also clearly stated in the reports that the monitor went on-site, yes or no, or if it was a remote visit that he needed to be performing. Also, the study-specific documents were updated. For those trials that were affected, we made the necessary updates to the documents, such as, for example, the project plan, monitoring plan, and the risk management plan, also to make sure actually that all actions that were taken and what the impact was on the COVID pandemic, that also that was really well documented in our study-specific documents. More in a general way, we also at the SGS Clinical Department, we also revised our procedures and also our document templates.
So, now actually these procedures and templates include some more flexible language that allows now our CRAs to do some more remote monitoring work, if allowed, of course, by the site and if applicable for the site in case, for example, we would face a similar situation in the future. I already mentioned that indeed we needed to document all the actions that we needed to take in order for a study to continue during the COVID pandemic. And one of the documents that needed to be updated as well was our Risk Management Plan. So, for the studies indeed that were going to continue during the COVID pandemic, we did a risk assessment or a reassessment.
We really evaluated all of the potential risks that could occur during the study, and here actually you can see an overview of the different risks or some of the examples of the risks that we handled during this risk exercise for the studies. Of course, we evaluated for each study separately together with the client, with the sponsor, and with the investigator if, for example, we needed to accept that risk or, for example, if we really could implement some preventive measures, yes or no, to avoid the risk. All of these risk assessment activities, as mentioned, were documented in our risk management plan.
Then, another recommendation from the regulators was really to build in robust follow-up measures, and also those robust follow-up measures, so, of course, they needed to be planned upfront and needed to be ready to be implemented at the moment indeed when the situation got back to normal. Of course, situation back to normal, at this point, we are still not in a normal situation, but SGS took actually this recommendation or tried to implement this recommendation from the moment that we felt indeed that the restrictions at sites, at the hospitals or at the countries, that the restrictions were more flexible, less strict, and that indeed our CRAs, our monitors were allowed again to travel and to go on-site. So, these follow-up measures for certain sites, this meant indeed that we needed to increase on-site monitoring activities to compensate for the impact of the reduced monitoring activities.
For other sites, this meant that our monitors needed to ensure that problems that occurred due to the COVID pandemic at sites, that these were rectified and resolved as much as possible, and then, for other sites, we also needed to assess and to plan actually re-monitoring activities of critical data that actually were shared for those sites that were shared by pseudonymized documents, pseudonymized scans, because, of course, doing the pseudonymized documents, that could not be considered really a source, so therefore, re-monitoring of that kind of data needed to be rescheduled again once allowed. Of course, that last bullet point is not applicable for the monitoring activities at our Clinical Pharmacology Unit, as mentioned, because they are using a validated eSource system. Everything is already being done remotely as much as possible.
At the time indeed when the situation went back to normal, more or less, and let's say that the CRAs, our monitors, were allowed to go back on-site, so at that time, the SGS Clinical Operations Department came or developed a decision tree with some questions, and this decision tree needed to ensure and to prepare the CRAs to go on-site. So, some of the questions included in the decision tree are related to the CRA general health, but also related to the rules and the restrictions actually and the current situation at the countries or the regions where they are traveling to.
Also, some of the questions, the fifth question that you see here, is then also related really to the site where they are traveling to, because, as mentioned already, for the CRAs, in order to go on-site, we really need the written approval confirmation from that site that the CRA can travel to the site. So, those were indeed questions in the decision tree, but also our monitors were, of course, made aware of the general hygienic instructions of wearing a mouth mask at all times, washing their hands at regular occasions, following the social distancing. Also, before going on-site or before scheduling their on-site visit, our CRA needed to check with the sites that indeed there was an area foreseen for doing the monitoring activities where actually the physical distancing could be guaranteed.
And also needed to check if the site in question also implemented those hygiene measures, yes or no. So, this last question, as already mentioned by Katrien for CPU, these preventive measures indeed and ensuring the physical distancing also for our monitoring activities, this was for the Clinical Pharmacology Unit at SGS guaranteed at all times. But in case for the sites who did not really implement those preventive measures, for example, the SGS Clinical Operations Department provided for our CRAs kits. Kits included, for example, the hand sanitizers, face masks, gloves, sanitizing wipes so that desks could be cleaned, and also airplane seat covers. So, making sure actually that also our CRAs could implement those hygienic measures themselves when they were on-site.
Of course, on all these questions in the decision tree, a positive or, let's say, a conform answer needed to be given in order for the CRA to go on-site. If this was not the case, if, for example, on one question, a non-conform answer was given, then actually the CRA could not go on-site and an alternative for monitoring activity needed to be discussed and agreed with the site. And this was actually my final slide related to the impact of the COVID pandemic on the monitoring activities at SGS ClinOps.
So, basically, I want to conclude here as well that also at the SGS ClinOps Department, and more specifically on the monitoring activities, we were also affected by the COVID pandemic, and we also tried to implement the recommendations from the regulators as good and as much as possible, but finding the right balance indeed between reducing on-site activities and trying to increase the remote activities at the different sites, this was a challenging exercise indeed also for us. However, what I do want to highlight again here was for our monitoring activities that were being performed at the SGS Clinical Pharmacology Unit. So, by using the eSource system, actually we were already in line with the guideline or with the recommendation from the regulators to do as much as possible remote work before actually this guideline was published.
So, with this final conclusion, I would like to thank you for your attention, and Katrien and myself are happy to answer any of the questions you might have in the next couple of minutes.
Thank you, Katrien and Martha, for an excellent presentation. We've received a few questions already, but we'll give the rest of you a moment to enter your questions into the Q&A box to the left of the slides. Before we begin the Q&A, I'll run through some brief announcements. First, I'd like to thank all of our sponsors for sponsoring this Digital Week. Next, I'd also like to mention that we have several clinical Digital Weeks and training courses planned for 2021. Also, we're excited to announce that this year, our Virtual Interactive Response Technologies and Clinical Trials Europe events are free to attend for pharmaceutical companies, biotech companies, regulatory bodies, academics, and nonprofits.
Please keep an eye out for more details to register your complimentary pass, access valuable knowledge and insights from leading speaker lineups, and benefit from lots of virtual networking opportunities. Also, be sure to check out the resources list to the right of your screen where you can download featured articles. Now, back to Katrien and Martha for Q&A. The first question we have here is, how was it possible for the COVID-19 vaccines development, phase I, II , III, and IV, to be completed in less than a year?
Yeah, I can take this question only partially because I must admit that we are a phase I unit and involved in early phase of vaccines. I'm not a vaccine developer.
I think there's quite some information available, though, in literature and in different media on that, because actually it comes down to everyone playing a big part in this, the pharma industry, but also sites as ours, our authorities that gave full priority to the vaccines, with clinical trials being evaluated and applications being evaluated in very short time. So, I think that's the bottleneck, just everyone put, yeah, did an extra effort on that. And I can only give an example on what we did. We are a phase I unit, normally participating in first-in-human trials, and vaccine trials are not really our core business because this is a trial with follow-ups and ambulatory visits. So, there are academic centers that are much, yeah, more into that, but we did participate in three just because of the need, and we gave priority to that as well.
So, that's just an example to say that we stepped up in that part also and gave it priority to help in recruitment in a multicenter setting, of course, and participated in these different vaccine trials. So, I hope that partially answered the question, and I think we can go to the next one.
Did you follow ad hoc conventions for AE recording when subjects were COVID positive but asymptomatic?
I'm trying to check what ad hoc conventions for AE recording means. So, I can just explain what we did as follow-up. So, indeed, if we had some subjects that were COVID positive and still needed follow-up visits, we aligned with the sponsor to do that on a remote basis, and as long as they remained asymptomatic, it was indeed mentioned in their file that they were COVID positive as an AE but without symptoms, and then it was closed.
So, it was indeed recorded. If there were symptoms, of course, we follow up the symptoms as another AE. And as soon as the subjects had done their quarantine and isolation part, they would, of course, come back to the unit to follow up. So, I hope that also is the right answer to that question. Then we still have time for another one.
Do you test at screening?
No, we don't. And we carefully evaluated that, but we don't see the reason to do so because there is three weeks between screening and admission in the trial. So, of course, at screening before subjects enter the unit, that was part of our risk mitigation strategy. They get a kind of questionnaire, and it's checked that they didn't have a high-risk contact.
While we all know the drill by now, they didn't have any symptoms, so they could only enter the unit and the screening visit when they answered negative to all these questions. We also have temperature measurements at our front desk, so they needed to take that as well. But apart from that, we don't test with PCR because a lot can happen in the three weeks. If they are tested because we had some subjects that reported a positive test because of a high-risk contact or symptoms via their GP, and then they were screened failed because of the COVID positivity. Otherwise, we would pick them up at admission. I think that's all I can say indeed about our decision for screening. Next question.
What was the impact of the positive cases for the trial?
Yeah, that's a tricky one in the way that it just changed last week. I normally would have said until last week that there was actually no impact in the way that, as discussed, we had to record it as an AE, of course, but most of the subjects that were positive had only very mild symptoms or no symptoms at all. So, those were recorded as an AE, and an AE related not to the IMP but to the COVID. There is one actually that was a little bit more ill and had a hospital admission, so that was one SAE due to that. That just very recently happened. But so, luckily, within a year, that didn't happen a lot. So, I must say the impact is very small. Another question we can take?
Yep. I understand that now the restrictions are being made more flexible in Belgium.
Subjects may be less inclined to participate in trials that require institutionalization. Is this making recruitment more challenging in the coming months?
Well, actually, we haven't seen any impact in any direction on recruitment. Our healthy volunteers were always still keen on participating, and it was just that with the traveling not being allowed because we also have volunteers from the Netherlands coming that they couldn't come for a while. So, they are actually all very eager to come. So, I predict actually an amount of those volunteers that will participate more in our trials. And restrictions, well, okay, I know we all would like to travel, that's for sure, but we never had any recruitment issues in other summer months or so because, yeah, people that are in our database are used to the fact that they need to be confined and institutionalized for a certain amount of time.
So, for me, the only impact on recruitment would be for the few trials where the COVID vaccination campaign may be a bit influencing but not the institutionalization.
How do you think it will be after COVID-19? Are there positive changes that will stay?
Yeah, that's, I think, a question that I can take. Yeah. So, as mentioned, we're in the SGS Clinical Operations Department. So, during the COVID pandemic, we really also revised our own procedures. So, our procedures, our templates from our documents now really allow some more flexibility to do actually some more remote monitoring work by our CRAs, of course, if it's allowed and acceptable for the sites that they are managing. Also, for our CRAs, yeah, although they are indeed allowed to go on-site, the time that they are allowed is now very limited.
So, before the COVID, let's say there weren't any restrictions on time to go on-site, but now really the time on-site is really limited. So, they need to use their time on-site really in an efficient way. And also, for that process, actually, we did a complete revision of the process so that indeed our CRAs would only, yeah, do the tasks that were really needed on-site and not do any of the activities on-site that for sure could also be done remotely. Another new implementation that for sure will also stay is, for example, when our feasibility team, for example, at SGS is looking for a new site or, yeah, selecting a new site, for sure, at this point, they will already check with the sites in case a similar situation would occur and more remote activities would be needed.
For sure, it will already be checked and assessed during that selection phase that that site in question actually is open to do some remote SDV, SDR, and indeed could also facilitate that remote monitoring. So, I think that's for sure, yeah, a new thing, a new implemented thing at SGS, and for sure, this will stay. So, yeah, so that was, I think, yeah, the most updated I can think of now. Yep.
It looks like we have no more questions for now. I'll give everyone another 30 seconds just for a last chance to pop any questions in. Okay, we have no more questions. So, I'd just like to say a huge thank you, Katrien and Martha, for a great session. If anyone submitted a question that wasn't addressed, keep in mind that the speaker might reach out to you following the session.
This session was recorded, so you'll receive a notification in 24 hours when the on-demand session is available for viewing. Please take a moment to complete the feedback form so we can continue to improve your Digital Week experience, and on behalf of Informa Connect Life Sciences, please have a great day.