COVID-19: Navigating the Pandemic: – How with COVID-19 effect research studies and clinical trials?

COVID-19 has spread to more than 60 countries, causing tens of thousands of illnesses and thousands of deaths. Pharma companies, biotechs, governments, academic institutions, nonprofits and others are all racing to develop a treatment, a cure and a vaccine.

Moderator:
Craig Lipset
Independent Advisor, Former Head of Clinical Innovation, Pfizer

Panelists:
Brian Neman
CEO and Co-Founder, Sanguine

Lisa Tindell
Vice President, Clinical Research Operations at Minneapolis Heart Institute Foundation

Sal Salamone
Editor in Chief, RTInsights.com

Transcript

John:

We would like to welcome you to the Sanguine Speaker Series Webinar on COVID-19; Navigating the Pandemic. Our moderator is Craig Lipset. Craig is an independent advisor and former head of clinical innovation of Pfizer. Our panelists are Brian Neman, CEO and co founder of Sanguine, Lisa Tindal, Vice President for Clinical Research Operations at the Minneapolis Heart Institute Foundation and Sal Salamone who is editor-in-chief of rtinsights.com. Now I’m going to hand it over to Craig. Craig.

Craig Lipset:

Thank you so much. Good morning. Good afternoon everyone. Thank you for joining us here and sharing some time as we talk about clinical trials today in the environment that we’re operating in. During this time, I’m looking forward to speaking with our panelists both about the state of current trials that we’re trying to manage, the delays that are taking place and what we can do during this window and also brings the [inaudible 00:01:00] on the future. And what does the future start to look like that may be different on the other side of this pandemic.

Craig Lipset:

As was mentioned, I’m Craig Lipset and I’m going to be moderating this session and just one update, I used to be at Pfizer, I am not Pfizer any longer. I have my own advisory service in this space, it’s around innovation and clinical trials. With that I’d like to go around and let’s meet some of the panelists we have today and as I allow them to introduce themselves, I’d like to ask each if you could just share not only who you are and where you’re working, but a little bit of the perspective that you’re bringing today on the impact of COVID-19 in clinical trials. Lisa, would you mind getting us started?

Lisa Tindell:

Sure. Hello everyone and thanks for joining. My name is Lisa Tindell. I’m the vice president of Clinical Research Operations for the Minneapolis Heart Institute Foundation based in Minneapolis, Minnesota. I have the pleasure of serving as one of the leaders in the Clinical Trial Space for our organization. We have about 192 trials up and running now. So as you can imagine, it’s quite a operation for us, not only in this pandemic, but kind of what the future looks like.

Craig Lipset:

Thank you. Lisa. Brian, Brian Neman. If you’d like to introduce yourself, what perspective you’re bringing for this conversation today?

Brian Neman:

Absolutely. [inaudible 00:02:25] be able to do this after so long Craig. So thank you for having me on. Yeah, my name is Brian Neman. I’m the founder and CEO of Sanguine. I started the company about 10 years ago, and the vision was to enable and empower patients to take control of their condition or research for their condition by participating in research from the comfort of their own home and through a different digital means that increase, essentially make it as easy as possible for them to participate. Over the past 10 years we’ve worked with, I think we’ve completed over 600 research studies. And most of those studies included home visits where either phlebotomist or nurses would do anything from a blood draw to topical treatment administration.

Brian Neman:

And we’re seeing a lot more CROs and sponsors and sites reach out to us for support as it relates to home visits and that really relates to non COVID studies. So performing visits for trial, continuation for non COVID and then for our COVID studies because of the decrease in, I’d say the overcapacity or the increased use of the healthcare setting and decreased capacity for people to actually go into the centers we’re actually performing home visits. And we have a unique perspective on how home visits are helping essentially create a registry or a bio bank for COVID-19.

Craig Lipset:

Great. A lot of perspectives there, whether it’s around shifting for follow up to the home both current studies in the portfolio as well as for some studies emerging during this pandemic. Sal, good day. Thank you for joining us. Would you like to introduce yourself and the perspective you’ll bring today?

Sal Salamone:

Oh, sure. Hi. I’m the editor-in-chief of a community website called RT Insights and it focuses on anything to do with real time analytics of information. My link into the drug discovery, drug development community it is I’ve been for about 20 years working on how to use information technology to accelerate drug discovery. I was editor at Bio IT World. With COVID-19, it’s been very interesting to see some of the application of things like artificial intelligence to processes that were in the past may not have considered it. And looking at ways that some of the basic research is being accelerated with different types of machine learning technology and other approaches.

Craig Lipset:

Fantastic. Let’s jump right in. Lisa I’d like to start over with you. Right now there is an entire global portfolio of medicines that were in clinical trials a month ago, two months ago. And we’ve been following the stories about how these are seemingly grind to a halt in many cases that certainly new studies starts are on hold while at the same time the enrollment for active studies seems to be paused. What are you seeing on the ground right now around the studies in the active portfolio or any perspective on ways that people are being successful in adapting their studies to this new environment to maintain some continuity. Lisa, can you get us started there?

Lisa Tindell:

Absolutely. We’ve seen for the most part about 95% of our studies that have completely stopped enrollment. We are fortunate to have a handful of studies that we can continue to enroll, albeit remote. There are some studies that are necessary for patient management and their care that involves research so we’re lucky in that regard. But for the most part we’re on hold until several months from now.

Craig Lipset:

In terms of any new study and enrollment happening.

Lisa Tindell:

Correct, correct. Very small margin.

Craig Lipset:

What about for the studies that were ongoing? What are some of the strategies that you are seeing groups employ to try to maintain continuity for those patients who are already on investigational medicines?

Lisa Tindell:

Well, we have nurses who will feel comfortable going on site and seeing those patients in a very strict and compliant way in terms of some of the restrictions that we’re seeing with face masks and hand washing and all those sorts of things. So we partner with those folks individually and connect with them and we either ship the medications to them or for those folks that need a special assessments, we bring those in in a very secure area so that we maintain all the strict safeguards that we need to.

Craig Lipset:

Fabulous.

Lisa Tindell:

Yeah.

Craig Lipset:

Lisa, one other question from a site perspective. I think some people are worried about side viability during this time. In particular perhaps the smaller independent sites that are out there this is certainly a challenging window in terms of the revenue models that many of those sites operate under when you’re not able to start new studies or enroll new patients. Do you sense that concern out there among perhaps some of the smaller independent sites in this country or around?

Lisa Tindell:

I would say that would be true. We’re very fortunate that we work in a large healthcare system called Allina Health and we’ve partnered very closely with them. So we’re lucky in that regard that we can continue to be part of the care. But I do worry for the smaller institutions that cannot sustain their financial model based on this hole that we’re in.

Craig Lipset:

Great point. Brian. Let’s talk a bit about some of these countermeasures that people are deploying. It seems to me that the top three things that will keep a clin ops team awake right now are, can I get drug to this patient who’s relying on it right now? Can I ensure that I’m monitoring appropriately for clinical and safety monitoring? And can I get my assessments I need in terms of the outcomes for this study? The data, the reason I was doing this trial in the first place to understand efficacy and safety. How much of this today do you see shifting to the home? Is that feasible to shift most of this into the home or are we going to have to see studies start to terminate early because of just too much missing data during this time?

Brian Neman:

Yeah, so that’s a great question. So I’ll tell you what we’re seeing on the sponsor side and then what we’re seeing on the site side or like the large house systems. And then I’ll share a kind of what our recommendation is or my recommendations. So what we’re seeing is that sponsors are looking across all their portfolio and thinking to themselves, okay. There are a big percentage of these, a large number of these, let’s say out of 10, we know that seven out of 10 of these are just not going to work as Lisa indicated. There’s no way to do anything about it right now. Then they’re looking at the three out of 10 and thinking to themselves, “Okay, out of these three, which one of them can we do fully remote? Which of them can we bifurcate the model where some of the visits are at home and then we push for things such as radiology or infusion or chemo.”

Brian Neman:

And then I think that where some of the clin ops teams are starting to push the envelope because another now the risk profile of all of these studies has changed. Now the risk is, are these studies going to stop and are we going to have to start from scratch or is this trial going to end? Or what are the things that we can do to push the envelope or mitigate risk of this closing by potentially increasing risk operationally? And the answer is that, I think that some of the recommendations we’re hearing, so just can we do infusions at home or chemo at home?

Brian Neman:

I don’t think that that’s going to happen anytime soon. And infusion, I think that there are high risks for SAEs. I think that just noninvasive exams, it’s special exams that can be done by nurses such as for Alzheimer’s, the MMSE scoring and other sort of vitals. I think that those noninvasive procedures can be performed, no doubt. I think that other folks are trying to think, “Okay, well what can we do to just, let’s say just focus on blood draws only and make it as simple as possible so that we reduce all of the visits.” So I think that the clin ops folks and sponsors are thinking of it that way.

Brian Neman:

I think that one other approach that could be powerful is to, if the sponsor is working with a top health system such as let’s say Providence or Scripps or like kind of a regional centers that have a very large footprint in an area that has the horsepower to enable certain functions or is well capitalized or that are well capitalized, that can deploy operations or funding in the immediate term very quickly, such as let’s say for example, Scripps or Providence, Providence Saint John’s.

Brian Neman:

So when you’re looking at those organizations, they can look across their clinical trial portfolio and figure out which of their studies or which of the visits within those studies can be performed at home. So what I would suggest final pieces is that the best thing to do would be to, if you’re a sponsor or you’re a clin ops at a sponsor organization, work with your top sites to figure out if they can start contracting with their own vendors as opposed to you doing your own work of identifying vendors. I think that if you’re the sponsor, you’re going to have to work with your own partners to find vendors and find vendors on the ground.

Craig Lipset:

That’s an interesting question, Brian. I often wondered about when sponsors are contracting home health providers to support their studies, they’re contracting a third party to do the work that is the obligation of the site. And so what is that relationship between a home health service provider and the investigator side, what is that supposed to look like and who should even be owning that relationship is an interesting question.

Brian Neman:

That’s a really good question. And I think the answer to that is dependent on the capacities and the capitalization of the health system. So if you’re talking about a group like Providence Saint John’s for example or Ascension Health they generate most of their income as we know in healthcare from surgeries and for other treatments which are much higher margin. Most of the visits are what can be performed at home such as a blood draw or noninvasive procedures Medicare or the payers will not reimburse high margins for those visits. So when you’re looking at the health systems, really you’re looking at revenue or profit per square foot and the large health systems, if the are, which most of them are sophisticated in their financial understanding, they will understand that to maximize revenue or profit per square foot because they are in the real estate business after all.

Brian Neman:

That they will want to move all of the non profitable or I’d say non-reimbursable or not high reversible projects or services outside of the setting. So what do I mean by that? You’re already seeing that in telemedicine. So you see all the top health systems that are enabling telemedicine to be performed for their GPs. Why? Because you need to get all of that high volume in order to funnel to the specialists, which generate the most income for the health systems, whereas now I’m shifting gears to the sites, small sites, which are let’s call it like five to 10 physicians their economics, they’re focused on, trials generating income for [inaudible 00:15:11] is a big piece. And they don’t have the margins of let’s say 340B pricing allows.

Brian Neman:

So these large health systems, as we all know is 340B pricing. They have a lot better margins on drugs, so they get a lot cheaper than this private centers. So I think that the smaller sites from a cost or a capitalization standpoint are going to have a larger… You spoke about what’s that sort of tension between the investigator and the home visit vendor? So I think that the smaller organizations have always seen it as revenue coming out the door whereas the other organizations with large health systems look at it as a way to actually focus on the higher margin activities.

Craig Lipset:

Thanks Brian. So there’s clearly a role for technology and analytics to help make existing trials sustainable in this environment. We can’t get monitors on site, we can’t necessarily make data magically flow out of the site, what are some of the strategies that you’re seeing for using technology data and analytics at this time.

Sal Salamone:

There’s several things that I think a lot of what’s happening with COVID specific work now I think is more applicable to the next case because where we’re coming in a little sort of too early in the types of things I’m seeing come in a little too early to get to the clinical stage. But what areas that I’m seeing very small one off examples are folks using remote process automation, RPI technology to help automate some of the things about qualifying candidates, chatbots, those types of things. Like I said, very small numbers of examples, but just to try to help get the right population and obviously a lot of remote technology, being able to have smart devices smart solutions out at the patient’s home to be able to not have to keep sending folks out all the time or at least to use the folks that have to go on site as efficiently as possible. So it’s things like that.

Sal Salamone:

The other area is Kadu take advantage or at least identify what could be a useful drug candidate for a trial. And there’s some very major efforts from a national level, White House, Department of Energy, IBM effort to bring all the resources of the super computing power to the community. That’s one that’s really getting a lot. And one of the main things they’re looking how to use AI to reposition existing drugs to apply to COVID. These are very more, I wouldn’t say academic but a little too early for application right now, but I think it shows what can be done ahead of time, the next time we have a pandemic or we identify a virus early on.

Craig Lipset:

We will definitely come back to this topic about what becomes the new normal. And Lisa, Sal mentioned an example about using technology to try to remotely screen for patients. While you may not be able to enroll patients at a site level right now, are there still opportunities to support screening for potential participants even though we may not be able to bring them in just yet.

Lisa Tindell:

So as we look at virtual visits our physician cardiologists are performing those on a daily basis to get linked into those virtual visits to screen patients as we can. We also pulled lists from our electronic medical record that will help us identify patients a little bit more readily. The work shouldn’t stop. We should be ready for when we come back online. And as soon as we put everyone remotely, that what our plan is, we need to continue the train of working with patients and knowing that we’re still here, we’re still looking for their participation and that is the goal for when we come back online. So there are a lot of opportunities that we have implemented in our organization to continue to do that.

Craig Lipset:

And Lisa along those same lines there have been people questioning why we do a hundred percent SDV for quite a while. And is this the time, are people starting to back off in terms of what they’re expecting for monitoring when they’re coming on site? Or is this just going to be an incremental blip? And as soon as the doors reopened, they’re going to want series to start catching up on STV from potentially weeks or months of not being onsite?

Lisa Tindell:

We’re going to do the best we can. We will have people and sponsors in our office as soon as possible, as soon as it’s feasible. I think they will catch up as we will also. And so I think it’s just going to take some time to see what those gaps are and then just start from beginning and work our way through it.

Craig Lipset:

And last one on this thread, Lisa. Every country is probably going to reopen at a different schedule and likewise, it’s probably the case for every every state, every major city is being impacted differently. Do you expect that you would be operating at a different schedule than other cities and States in the US and does that make sense for how we start? What will be the trigger that should let sponsors know that you are ready to be back in open for business?

Lisa Tindell:

So we are still in business but we’re limited by the-

Craig Lipset:

Thank you

Lisa Tindell:

We are limited by the restrictions that our healthcare system has and we absolutely will abide by those. I think we will be ahead of the game in that regard. We’ll be ready and as we transitioned our staff offsite will also transition them back and in a strategic sort of way. So when we have trials that are ready to go and we have restrictions that are lifted from our health system they will absolutely let the sponsors know. And I think we own that on the on the site side. And so that’s going to be the first phone calls, “Hey, we’re ready to go. We’ve made all this progress since we’ve been out and now we’re ready to enroll. Are you?” so we’re planning for that now.

Craig Lipset:

Brian, what other criteria are you expecting to need to see in order for sponsors to start to resume new study starts? What is your expectation that you’re planning around as a business leader for new studies to come back online?

Brian Neman:

As Lisa indicated we’re looking for the local leaders providing feedback on when it is appropriate and then it is safe to start new. And I think it’s really based on the comfort level of the organizations and really from a regional perspective what the comfort of the citizens are. So we have some clients that are not based in the hot areas, so to speak of the Massachusetts or San Francisco and for example, in Connecticut folks are ready to go. Everyone’s at the office, believe it or not. And there hasn’t been as much of social distancing. And what I mean everyone, I mean everyone from-

Craig Lipset:

I thought Connecticut was in between New York and Boston last time I checked. I thought they’re getting pretty squeezed, but maybe there are some pockets in there and we have really like hyper local.

Brian Neman:

Yeah. So folks that are in the labs. So when I mean everyone, I meant everyone on those lab teams that are still coming in to [inaudible 00:23:37] for example, excuse me for that. Not everybody. And not the business development folks or sales, for example. Most of the lab folks still come in to continue business as usual, research? Yeah, it depends on rural areas. If it’s just using common sense or from that point. So local the leadership, company leadership is also critical. So what we’ve seen is that the companies that let’s say have a German parent and as Germany is opening, I think on Monday, they’re starting to re-open back on Monday. So depending on the guidance from parents or parent organizations that impacts on the opening. So that’s what we’ve seen. Local parent company leaders.

Craig Lipset:

Sal study teams today have vast parts of their portfolio on hold. Pharma is not exactly furloughed employees so these people are still there and in many ways they have the gift of time. They have a study that they thought they had to go live with, but maybe they’re delayed with that start by maybe it’s two months, maybe it’s three, maybe it’s longer, depending on what countries they were planning to aim towards. How might they start thinking about technologies or other strategies that could help them today that maybe they hadn’t put into their plans, but because they have a few months right now, these are some tools that maybe they could start to introduce?

Sal Salamone:

And I think it gets back to that point I made that were kind of like one pandemic and ahead. I think right now. There has been an introduction of a lot of new technology or exposure to it. Tools that we’re seeing… A lot of these data science communities that have started things like, there’s an interesting one. It’s a pandemic hackathon and they have 230 projects going and it’s everything from looking at the pandemic response rates and very minutiae detail that it… Certainly the information is out there, but to be able to assimilate it, see it, make some sense of where we should be looking. And I don’t mean just like infection rates or anything like that, but really great detail able to simulate a lot of different information quickly and use machine learning or artificial intelligence to make predictions about which population might be more susceptible, where would the spread be next?

Sal Salamone:

Now these are techniques that are used in other markets that are now being applied here. And the life science is really for the first time I think to the extent that we’re seeing. Some of the things that are just basic research things to, maybe you want to take another look at the literature. So there’s is this one project, Wall Street Journal wrote about it where a group of data scientists volunteered and put together something where it gave you a tool of research. You could look at 46,000 papers that have been written over the last decade or so, quickly analyze, draw insights from them.

Sal Salamone:

So those types of things that are going to be available, they’ve been sort of rushed together now but we’ll be able to use them and like they’re available now. They’re all seem to be, everyone’s offering it free or here’s access to this… Trying to find the stuff is probably the hardest part. But those types of things, to look for those types of things out there that maybe give you a different perspective about how to, which population to pick, how to roll out the trial. Those types of things are what I’m looking at.

Craig Lipset:

Like I said, it certainly does seem like this is a window of opportunity for those with new study starts to make sure that when their trials do go alive, they don’t end up having to then take another step backward. There should be a little willingness to accept say having a protocol amendment early into a new study because you failed to really evaluate its feasibility or otherwise. What other recommendations do you have, Lisa, for research sponsors today to take advantage of this delay and make sure those studies are going to come out of the gate strong?

Lisa Tindell:

Gosh, it’s really hard to say. I think patients and understanding would be my first request. Weren’t here and we’re still working on the studies. We’ve contacted thousands and thousands of patients, so we’re maintaining safety. We’re also bringing in the physician investigators as well, so they’re well aware of what’s going on with their studies. We continue to capture serious adverse events and adverse events just like we always have. I think the other piece to keep in mind is that we’re not used to being remote. I’ve been a nurse for a long time and this is the first time I’ve ever had to work from home exclusively. So this is a new thing for us. So just patience and understanding as we get through this together.

Craig Lipset:

Fabulous. It certainly seems like a great window of opportunity for study teams to really red team and challenge their protocols, take advantage of different both software driven approaches to evaluate your protocol feasibility and optimization as well as human driven approaches and talk to investigators, study staff, and perhaps most importantly, if for some reason you didn’t do it before this window of time, go talk to some patients and make sure that they actually feel they could live in and participate in your trial. Brian, do you have other thoughts on things sponsors or rather teams could do during this window for studies that are delayed?

Brian Neman:

Yeah, I think for studies that are delayed I’d say we have a unique perspective in that what actually ended up happening is that most of our studies will not hold that were not on COVID and then we saw an explosion of COVID requests in the past two and a half which was completely unexpected. And so what we found is that to engage individuals diagnosed with COVID and perform those home visits, obviously you have to go through different methods. So PPE and supplies and having backup supplies so sharpening our inventory planning that was a big piece.

Brian Neman:

Another one is a better understanding the patient community because individuals like diagnosed with sickle cell behaved I think differently than those diagnosed with, or recently diagnosed COVID which is going to be at some point all of us or a large percentage of us. And the point that we’re trying to make now is that we’re looking at different ways to engage individuals because what we’re seeing is a more peer to peer sharing of information as opposed to just social media, LinkedIn, just in your face advertising because people are communicating with each other more and more through Zoom through LinkedIn through Facebook, Messenger, WhatsApp, Instagram, all those different assets. So what our organization is focused on is finding other ways to engage individuals on a peer to peer basis, whether it’s referral program or points incentivization, gamification, which you introduced almost a decade ago. So we’re looking at sharpening our tool set so that when we are turning everything back on then we can increase efficiency.

Craig Lipset:

Brian what kinds of requests are you getting for COVID 19 related work? Is specimen collection? What the type of requests coming in right now?

Brian Neman:

Yeah, so we’re seeing two different types of requests. So from the health systems, large health systems, which no one’s going to come in or no one wants to come in, I should say. They need help with the home visits from individuals who have recently recovered from COVID to collect samples for studies or just to the bank for the future. So that’s one. So that’s specimen collection only. The other large pharmaceutical companies and biotechnology companies so we recently announced a partnership with Veer which is developing an antibody for COVID. So organizations like that, not specifically Veer, but other organizations are asking us to identify subjects, consent them and then perform the home visit to deliver the blood either directly to the sponsor or to the lab where the samples are separated to serum, banked and then sent out. So that’s what we’re saying.

Craig Lipset:

Great. Thanks Brian. Please keep those questions coming in to the audience. They’ve been great and I’m hoping we can just keep weaving them right into this conversation with three experts. Lisa, I’d like to just go back to you on one area I’d like to double click which is we were talking a moment ago about can you still screen patients for some of the studies where recruitment may be on hold. One question that came in online is can coordinators working remote have access to the EMR to continue searching for patients or even continue to engage those patients and screening for a study that is open, but where recruitment is delayed.

Lisa Tindell:

So certainly it’s been a challenge and four weeks ago I stood in front of my staff saying, “You know what? Guess what, you’re going to have to be on site because there’s no way that we would have access to the things that we need if you’re remote. So here we are four weeks later and mobilizing 36 staff members to have access to the EMR, electronic medical record as well as databases or electronic data capture systems that each of the sponsors have has been successful. We do continue to screen, we do continue to retain those lists and we do continue to enter data into the database. So yeah, we have done that and it’s… As me as a traditionalist, I’m shocked and surprised and pretty proud of the staff.

Craig Lipset:

That’s fabulous to hear Lisa. This next question comes from a person I have great respect for. So I’m going to call him out by name and I’d like to thank Ray Dorsey for posing this question, which leans into the future of clinical trials and whether the future is going to look less traditional and more entirely remote. I will say that Ray is a thought leader on the topic and is driving some of the most innovative programs certainly in the neurosciences and in Parkinson’s also put out a little plug that he has a fabulous new book on the future of research in Parkinson’s, raised up in Rochester.

Craig Lipset:

I’ll stop preaching his praises, but I obviously admire rate quite a bit. But let’s go back to the question from Ray. I’ll stop sounding like his grandma. So let’s talk about what the new normal may look like. Brian, let’s start over by you. As we think about this future of clinical trials, we’re seeing people scrutinizing the amount of data they may be collecting. They’re re-looking and their monitoring approaches, they’re pushing things into the home. Is this just a painful blip on the radar? Is this the new normal or is it something in between?

Brian Neman:

You know I’m biased. So I think when… I’ve been reusing a quote from you that you spoke about, I think about a few weeks ago, was that people were looking at home visits as a risky add on and now they’re looking at it as more of a risk mitigation strategy. So I do think I’d say that I say that organizations will be more welcoming as an add on. I think that sites are going to be more open to it, the large health systems than ever before. So I think as sponsors, we’ll consider it. If they do think that it is valuable. So depending on the outcome over the next few months and let’s say that home visits really does make a difference or really does increase trial continuation, trial continuity, then I think that the clinical operations, our group is going to go back to the finance group and carve out a potential budget on each particular study. Let’s say it’s tough.

Brian Neman:

So well I think… Do I think that home visits are going to be enabled for oncology studies? Maybe, maybe not. For rare diseases where the patients are immobilized or a pediatric conditions where the whole family has to take their child to the site, I think that we’re going to see some acceleration in different pockets, not necessarily the whole picture. That’s what I’d say more therapeutic driven.

Craig Lipset:

Sal the tools and approaches people are running to for help right now aren’t necessarily new. Nobody had to go back to the technology workbench and invent something new. Right now it’s been mostly a barrier of adoption. Do you believe that this will become the new normal, some of these strategies? What will it take for that to happen?

Sal Salamone:

I think so. I think one of the things is just to see what some of the results are already and particularly the helping to identify drug candidates but also patient populations using machine learning to really quickly re-examine the literature and try to draw some insights where then you would go in and do your own more thorough but to convince it down. The other areas that I think to me that’s the most exciting is using automatic processes and especially like chat-bots to recruit, to find candidates. Other industries like the fast food industry needs huge numbers of workers. And it’s also one to do with their age. The younger people don’t want to do fill out forms. They don’t want to send in a resume.

Sal Salamone:

A lot of the fast food chains now are doing almost all their recruitment via text and automatic response systems. Some of them have brought it to the interview stage and do a thorough interview with an automated chat bot to narrow it down to somebody then you talk to. So I think those types of technologies have the application here. I think could really perhaps eliminate some of the very early stage groundwork to better candidates at the start and offload some of that mundane and necessary work to automation. Will it happen? I don’t know. But it’s already been done in other industries.

Craig Lipset:

Okay. So I have to ask this question because I see one attendee online who used to work on my team at Pfizer and we used to focus on this. How do we make sure that the technology we’re experimenting with is what the users, in this case of that example, the patients actually want? And that we’re not just using the technology because we can but that it’s something that we know the patients or other users will actually we’ll solve a problem for them.

Sal Salamone:

Right. As we’ve seen with everyone doing Zoom like our grandparents and parents had to adopt fast. Certainly with the fast food industry, the folks they needed really wouldn’t bother applying any other way. So that was a perfect match. The technology that they’re used to texting automatic reply systems is a perfect match. If you’re need of a patient population that’s not in that category, certainly it might be something new to them or different. So it obviously you do have to match the technology to the audience.

Craig Lipset:

most definitely. I certainly lived that experience when we started looking at chatbots for some of the interface off of clinical trials I got for patients and making sure we understood at least for patients where they are today, what their priorities are. Absolutely. Lisa, what are your thoughts in terms of the new normal? What do you think will look different for new studies that are coming together in a year or 18 months from now?

Lisa Tindell:

I’ve certainly seen the shift in newer technology and newer capabilities from the sponsor. We do use home care but I do believe that we need to meet the patients where they are. If they’re not ready for this type of technology, then we have to revert back to the old way of doing things and that’s okay. I think it’s advantageous for us to continue to move and being the type A person that most researchers are, it’s hard to give up that control and that’s okay too. We’ll just say [inaudible 00:41:23] to make the right decisions at the right time for the right people.

Craig Lipset:

Lisa, when you see things that may shift to the home in particular around the use of different technologies, I’m sure you have studies that are using different technologies that are patient facing, whether it’s an app or a device or a sensor, how much work does it take to train or orient a patient on using that and how can that shift to the home going forward for can it? Or is that what home health providers don’t want?

Lisa Tindell:

Yes to all of that. I think there has been an interest to use technology as far as the time it takes to train, I don’t feel that it’s any more laborious than anything else. We have the blessing and the beauty of having families also involved. Most of our patients are well versed in a lot of the things that are out there in the public domain so we also know that they’re out there too looking and expecting that from us.

Craig Lipset:

Excellent. Brian, what do you think companies research sponsors need to do internally to commit to this change? What’s going to be the tipping point in terms of sustaining adoption of these approaches?

Brian Neman:

Really, it’s tough to say. I’m really a skeptic on what is for here and what is for the future. I think like I said the home visits is a big piece. I think that overall we’re seeing a lot of pressure testing of what will work now and that’s going to build confidence for the sponsors so that when the new normal when it does come, when the dust settles and we do come to a new normal, I think that those technologies that have been pressure tested and will remain, I think the chatbots certainly interesting. I think electronic informed consent I think that has been kind of like a laggard over the past 10 years. I think that now if that’s not in and no one’s… I think the expectation is that that’s going to have to be good, like no more non-electronic ICF.

Brian Neman:

I think that’s definite. I think there is some room for new technology such as TriNetX or Deep 6 that have essentially allowed for identifying patients without having… Just looking at the EMR. That’s also interesting. But I also think that hospitals moving to the cloud completely and so you saw that just in the news with the AWS and Google cloud, I think that that’s a new norm. So that’s kind of outside of clinical research I’d say. But obviously clinical research is a function of what’s going on in the healthcare system and I think that moving the records to the cloud when that’s possible and just a data repository to the cloud, I think that that kind of the easy yeses, electronic informed consent moving to the cloud. Those I think are those… The laggards are now going to completely be converted. That’s my assessment.

Craig Lipset:

Okay. I’m going to give my panelists to say a lightening round here. I’m sure when you were thinking about coming onto this webinar earlier today, there was some key message in your mind that you wanted to make sure that this audience was coming away with, whether with regards to existing studies, studies that are delayed or the future and what it may look like. I’d like to give you each just a minute to either recap of points you made or if we didn’t get to it, please use that opportunity. Sal do you want to get us started?

Sal Salamone:

Sure. I think from my perspective, the interesting thing has been the rapid response of this whole community of data scientists at all to an issue that they may not have had any experience in, but they’ve brought tools in very quickly to help. And that’s a good model going forward. It’s everything from these simple to access data platforms. I’ve seen a number of them, these offerings, companies that have just thrown together something, a web portal gives you, here’s the 12 top databases you need to have to understand where we are today. To have realtime information aggregated quickly and presented.

Sal Salamone:

To be able to use advanced technologies, AI and machine learning to study anything which patient population is more likely to be receptive to or to react well to or something. Those types of technologies I think it’s a little futuristic, but to have that exposed in a broad way, it’s been done in pockets but this great response, this great exposure both ways for the folks on the clinical side that may not have seen some of these, you don’t want to use them right now, but maybe for future studies they could be of help. So that’s the main thing. I thought that the great response and the availability of these interesting tools has been fantastic.

Craig Lipset:

I think so. Lisa, a closing thought.

Lisa Tindell:

So certainly I’m super grateful for the technology that we have. 30 years ago this would have never been possible and we all would have been in a very different place. So research still is strong and it will be, and it’ll be even better than we were before because of this learning that we’ve done. But most importantly is the sponsors just to continue to support and enable us to become more technically savvy. And each consenting needs to be part of our portfolio and so continue with those capabilities. And more importantly, the patients are out there. They’re wondering what’s going on. And so once we come back online is to engage with those people to say we’re still here and we’re still here to support you.

Craig Lipset:

Thank you. Lisa. Brian.

Brian Neman:

Yeah. I’d say three things. The first is more realistic, which is praying for the worst. The second is use vendors that you trust that you’ve seen in other parts of the business. So in many organizations, the larger the organization is the higher the likelihood that the left and the right hand don’t speak with each other. So a work across the departments or therapeutic areas to share vendors. So there are some organizations where we only work with a rare disease research unit and we’re only getting feedback now which is great from folks in cardio med or oncology or inflammation, immunology. So work with other TA heads to identify vendors that work for them and shared resources there. And then the third which I may not be popular for saying this, but I think it’s quite realistic, is don’t over audit new vendors.

Brian Neman:

So what I would say is some of the questionnaires that we’ve been receiving, they’ve asked us to listen with our software, which includes Salesforce.com or Smartsheets and Box for example. And some of the requests we’ve had are have you audited salesforce.com. I don’t really know how to answer that. The answer is obviously no, but do you really want us to go through that? So I think we need to be a little bit more realistic and what is achievable in the time period relative to the size of the vendors and security of the vendors.

Brian Neman:

So if you’re going to ask us all, “Have you audited UCLA’s lab,” that’s something that is a legitimate request, but a hundred billion dollar company running like a security audit on them or have you audited Amazon web services? I don’t think relying on that or waiting for that to happen, I think you’re just shooting yourself in the foot.

Craig Lipset:

Thank you. Brian. Here’s my final thought for the participants out there. We’re all scrambling. Everybody is trying to work their way through this between their families, watching out for those that you love while also making sure that the studies that you have and that you’re getting going can happen. There’s a lot of rushing we’re doing and we’re trying to document everything along the way by all means. I would encourage all organizations to keep a parking lot of the areas that we have to come back to and make sure that we’re working to embed those in our organizations going forward. The things that we’re rushing to make work today, we need to then come back later in the summer and invest the additional energy to embed those that really make sense now to become a persistent way of how we operate. Whether that’s home health, whether that’s monitoring changes, whether that’s certain technology that we want to commit to continue to scale in organizations.

Craig Lipset:

With that I do want to thank everyone in this audience because this is a community of clinical research professionals. You are sponsors, you are a CROs, you’re a technologist’s, your sites, you’re participants in patients and the rest of this community, the world is watching you and you know that every time you put on the news you are seeing talk from leaders around the world of clinical trials like you’ve never heard before. And I know that this community is rising up to that challenge, whether it’s for therapies in vaccines against this pandemic or to keep the rest of that portfolio moving so that we don’t have a gap so that patients in two years are not suffering from a gap of new medicines reaching them because of the impact of this pandemic. So I want to thank all of you for continuing and persisting in the work that you’re doing. And of course I’d like to thank Sal, Lisa, Brian, and another Lisa who in the backend, pulled us altogether as well as our producer and MC John. So thank you very much everyone. Stay well.

John:

Thank you to our panelists and thank you for joining sanguine for our COVID-19; Navigating the Pandemic Webinar. We hope you can join us for our next COVID-19 webinar taking place on April 29th at 1:00 PM Eastern time. Visit researcher.sanguinebio.com for more information. If you have a need for patient samples for your research, please visit sanguinebio.com. Thank you again and enjoy the rest of your day.