Virtual Clinical Trials: The Pain of Change – can technology heal the pain?

Chuck Piccirillo

Clinical trials are no plain sailing for the pharmaceutical industry. With the innovative technologies proliferation, the life sciences sector is turning to Virtual Clinical Trials (VCTs), seeing new possibilities in their capacity to change the drug development scenario. There are some clear benefits that virtual approach can bring to both patients and sponsors as opposed to the current outdated, inefficient and costly model of clinical trials. However, there are some challenges to consider with VCTs including data security management, their implementation in complex trial designs, and also providing trial conditions, training for patients, patient safety, data transmitting, etc.

During our recent webinar, we provided a venue for Pharmatech, Biotech, Drug Discovery & Development, and Healthtech professionals to examine the current state of virtual trials under the microscope and to demystify the process of conducting them.

Together with our special guest, Chuck Piccirillo, we discussed the technology potential enabling virtual trials, and also the mechanisms to facilitate participation in clinical trials, including partnerships among providers, sponsors, researchers, regulators and patients to maximize the benefits while reducing the risks.

Chuck Piccirillo, a CEO of Zealic Solutions, is a pioneering pharmaceutical industry innovator, business software executive, a strategist and a renowned expert in development, commercialization and deploying solutions for SaaS businesses, eClinical , Healthcare IT, PACS, and Medical Device industries working in both entrepreneurial and blue chip companies. Chuck was enthusiastic to share his over 30 years worth of experience, which is centered around creating systems and solutions in the healthcare and life sciences space.  

Today, we are deep-diving into the likely future of virtual clinical trials and getting a view of some of the unorthodox strategies of the industry leaders in adoption and adapting to virtual trials.

 

Many years of experience building up to virtual clinical trials 

         When we talk about systems, it is important from the context perspective, that we’re all on the same page, in terms of it being more about the intersection between the ‘people process’ and technology. Chuck’s expertise lies with those complex systems, using them to really help transform parts of our industry, from a business perspective. 

He had the unique opportunity of actually being involved in pioneering an industry. It was centered around digital stress echo in the healthcare medical imaging world. Chuck spent a number of years after that involved in transforming a business and its systems from analogue imaging to digital imaging. Since moving to virtual clinical trials, there is a major ongoing transformation initiative within the industry, all his experience pioneering and transforming are key as they are highly applicable and very relative today.  

 

Shift from traditional to virtual clinical trials

Many may be thinking ‘I’m not as familiar with clinical trials as I’m more involved in the art of software development’.  The ongoing transition, from centralized or traditional clinical trials to decentralized, is very analogous, Chuck says, to taking a software company or software development team that is all co-located in an office and then running that project virtually, meaning that everybody is working in their homes. We are not too far from that today, considering the impact the pandemic has had on altering how and where we work.   

We all can appreciate the challenges and dynamics that come with such changes. When you start to look at the applicability of virtual clinical trials, the number one thing which stands out as a little bit different is that clinical trials are complicated and they are very complex projects. The complexity is exacerbated by the fact that from one clinical trial to the next, you’re sitting with another degree of variability, whether it’s the country you’re working in, whether it’s the systems you actually have to use, what therapeutic areas are involved, etc.

So you have this very complex project that was more centralized around an investigator (doctor) who really did a lot of the coordination and activities associated with it. The shift to virtual clinical trials (VCT) is now you are decentralizing those things; like breaking people out of an office and sending them off/home to work there. In clinical trials, the patient, through the investigator, is recruited, is qualified, is randomized, and the drug is administered. Treatment and monitoring has to occur throughout the clinical trial and they also are all centered around the investigator at the doctor’s office. Moving to a virtual approach, that is virtual clinical trials, we are essentially saying that we have to remove all of that and now deal with the fact that the patient (subject) is going to stay, for the most part, at home. All those things, everything from recruitment all the way through to drug treatment and monitoring, are now all done virtually. This definitely ends up adding a significant level of complexity to running that clinical trial and dealing with all the logistics associated with it. And from Chuck’s perspective, he believes that is what the industry is going through right now. Up to the start of this pandemic, we all were trying to figure out how to move towards virtual clinical trials.  Realistically, about a year ago the greatest amount of energy expended was in trying to make that shift.  

This pandemic has clearly caused a great sense of urgency and criticality to make that change from traditional clinical trials to virtual ones very very quickly, which is no easy feat.  It requires a shift in technology, like IoT, monitoring devices, and the current ability to connect with the patient while they are at home. Such as the ability to monitor the patient remotely, through those technologies, like capturing data and bringing that data back into the systems. It becomes literally a change in the way people work; for example, now CRAs (clinical research associates) are not visiting investigators to do source document verifications.  Even the qualification method becomes more challenging in this process and companies are still working to figure it out, across the industry. It’s a real challenge and Chuck says he sees a lot of good progress being made, but of course a lot more has to be done.

→ Explore more Pharma Legacy Transformation. Growing old vs growing wise.

Where are virtual clinical trials most applicable  

Clearly, Phase 1 is not applicable given the fact that it happens in a clinic, however Phase 2 and 3 are the cases of use. 

Given our situation around the world, as we talk about virtual clinical trials (VCTs), there is a glaring need for extreme virtuality, as much as possible. However, the reality of it is that what ultimately will end up occurring is hybrid clinical trials, still patient-centered but it isn’t to the point where the patient will only be participating as a subject from home. The patient will continue to go and meet a doctor/investigator, but really the goal is to make the experience for the patient easier, simpler, and more effective, and at the same time, reduce the number of visits to meet with the doctor/investigator as much as possible. We are using technology, different methodologies and practices to accomplish that. 

During our  previous webinar together with Michael  DePalma, a number of these issues were brought up as well.  For example, data privacy that is collected during clinical trials. Another example is e-consent, especially now in Europe with the GPRS.  They are getting the patient educated about what they will go through, what information they are going to be providing, and what risks they will be taking, as well as having all that information recorded.  With traditional clinical trials, patients would visit their trusted Doctor who would ask the patient to participate in a clinical trial, and then give them information about the clinical trial, the process, and the possible results.       

Answering any questions the patients may have and explaining the trial is, obviously, a lot simpler and easier being done through the doctor/investigator.  Beyond just e-consent, Chuck says that the regulations have something to say about that entire shift to virtual clinical trials.  He goes on to say that the pandemic has fueled even the FDA to embrace more than it has in the past, which is good for the process of transformation. 

Another consideration is that now you have a patient who before would go to the doctor, even if it was just to simply check vital signs, blood pressure, etc., but now VCTs require this to be done for the patient at their home.  Many participants are older and have issues with technology and are not computer savvy, and some have cognitive issues.  Education supports the entire change in the paradigm and it is also really key, because it’s important for this to be successful. It is a challenge no different than the e-consent.     

 

Skill sets are immeasurable   

At Avenga, we always look at skill sets.  How we manage this reflects in the brilliance of the work our 2500 professionals have achieved through our 20+ years of experience.  So, we asked Chuck his opinion on what skill sets a vendor needed to be helpful and attractive to either a sponsor or CRO. 

Chuck shared that all we’ve discussed during this webinar is fueling the need, or the creation, of more technology. Unfortunately, now from the clinical trials perspective and where we are today, there’s actually too much technology. It’s riddled with so many disparate systems. 

First, Chuck believes that companies like Avenga and others, can legitimately help the customers who seek them out, as the appropriate answer to hyper-technology is really centered around expertise in managing technology.  Those with the critical skill sets in technology are able to more easily and simply integrate these existing technologies skillfully and efficiently as it applies to the shift towards the needs of virtual patient centered clinical trials or even hybrid trials.

Next, Chuck pointed out that helping the industry avoid propagating more technologies and derivative technologies is imperative. We shouldn’t create a new breed of EDC systems or a new breed of CTMS systems, or engagement platforms.  Finding a way to actually tie all these things together to enable the shift in how clinical trials are run is paramount.  So this means not just effectively using what we have, but knowing which experts to turn to and when, as well as being able to think outside the box in connecting technology and patient safety in the best way to meet the need. 

Chuck thinks that with all of this, it fuels more data. Essentially, the e-consent form before was just a piece of paper that somebody decided on in the Dr’s office, which is just one example of many. Leaving paper behind and being in the electronic world, we are propagating more data swimming around each one of these clinical trials, which Chuck earnestly believes is an opportunity to actually improve the way clinical trials are run.  However, that data must be analyzed and leveraged effectively, and then good solid intelligence derived from it. So the whole world of data science, as it applies to understanding clinical trials, is another area where companies like Avenga can actually contribute to taking traditional trials and moving them forward.

 

The ‘must’ technologies for virtual clinical trials

  The reality of it is that technologies aren’t just in the life sciences’ clinical trials. You still have the same challenge even within the healthcare space. Electronic Medical Record (EMR) systems and others are also experiencing the same disparate problem, both in the definition of information as well as the variability of systems.  

Chuck brought up this issue, because we all know there’s an intersection of these two things and that intersection is happening even faster than it did before. The more rapidly those two things come together, clinical trials and the EMR systems, the better for everyone, in terms of developing drugs, faster, better, and safer going forward. The more these things are disparate, there is less of a standard between them. That definitely gets in the way of the worlds coming together.  

 

What skills are needed to work in clinical research organizations?

There’s no literal check-list per se, Chuck relates, but clearly, everybody who’s familiar with clinical trials can imagine what’s needed.

Having the ability to remotely monitor a patient and from their home is essential, obviously.  The good thing is there are companies out there that typically wouldn’t be playing in this space, but who actually have the pieces to do it and the services for support. Companies like Lenovo, as one example, who has this really nice homecare monitoring kit that does all of those things a patient needs to do for a clinical trial. They also have all the support infrastructure, because when something is not working, when it’s not connected, they are able to handle it. This is an important check-list item that is needed. 

Remote data capture is another key thing.  Some might say, ‘Wait we already have all those Electronic Data Capture (EDC) systems, and they’re all virtual and web-based, so what’s the problem?’ The problem is that it has to be done from the home.

So, is there a checklist of new things? Well, not necessarily, but there is ‘how do you change the ones we already have and that are in use’ to accommodate the different ways in which clinical trials are going to be run in a more decentralized way.  As we think through all that we’ve gone through already, plus the many current issues, we can say there are changes that need to be made. Some we are touching on  in this webinar as Chuck explained that he wanted to touch on the ones that he thinks are opportunistic, because everyone is already thinking about data capturing, engagement platforms, e-consent forms, and all of those.  

But that is just one level Chuck shared. In talking to some of the experts in the industry, there is a whole other level of complexity that needs to be focused on, which is around the logistics of running a decentralized clinical trial. Again, trials are complicated with lots of moving parts and a lot of people involved. In VCTs, we’ve taken these people and put them in their homes and said ‘I still want you to be a subject’, a patient subject, and we are planning to do all the same things somehow with them.

Bringing up a really good point, Chuck challenged us to dig deep and think of the simple tasks we often overlook that occur at the baseline of clinical trials. 

  1. How do you get the drugs to that person? Say, the drug actually has to be kept cold. What happens when the drug is shipped to that person and that person is not home, but the drug needs to be kept cold? Now you have a drug which is no longer viable. So there are logistics of coordinating things like that.  
  2. Another example is, you will often have nurses visiting these patients and being dispatched out to the different locations. This is very common for the companies that have attempted to go into the virtual trials base, as they already do this, however, when that ends up happening, the logistics of coordinating a nurse to go there, in respect to the availability of the patient, can cause unforeseen issues.  The nurse arrives and the patient is not home, now what do we do? Or the challenges associated with them arriving, and oh wait the patient has a dog and the nurse says “I’m allergic to dogs, I can’t go in”. 
  3. What about time requirements? Some of these not so obvious things have to be done in a time constrained way. So, now you’ve got these logistics of making sure it happens within the time limitations that are required in accordance with the protocol and the regulations. It results in a higher ‘miss’ rate, than you otherwise normally would have.  

So, a big question we need to ask ourselves is, ‘Are there solutions out there that are dealing with this?’ This is a perfect example of the opportunities out there to help move traditional clinical trials to virtual or hybrid.  

As we get back to the integration of existing systems, the intelligence of coordinating all that and communicating with participants is necessary to lessen the chances of these types of things happening. That is the opportunistic area that is really important, Chuck believes. Again, listening to the experts, some of the people in the forefront of it, these are the pain points that they’re telling us about and that they’ve been experiencing in trying to get into the virtual clinical trials; even before the pandemic started. 

When we talk about enterprise resource planning (ERP) we generally talk about pharma, the manufacturing of raw materials and the delivery of the final product.  Looking at ERP through this new lens takes it to a whole new level within the clinical trial.  Everything becomes much more time-critical and needs real-time coordination, even helping the patient to visit the investigator. Coordinating that and helping them get there, is just one example and there really are so many opportunities. If you want to talk about what patient-centric means, Chuck says he wants the patient’s experience to be much better, but obviously the outcome of the clinical study has to be effective. There is a lot of potential and opportunity for pre-thought out technology and it could have a significant impact on people and processes and lessen the pain points, and frankly, the costs too. Most of these logistical things you do with people are making phone calls, etc., and it means very common things can be improved.  As we all know, for CROs, it’s a very people intensive business.

But the reality of it is that there is a huge opportunity to leverage the use of technology to augment the people allowing them to focus on the trial itself; so they can stand back and see the big picture of what is going on.

As we build this webinar series, one of the things Avenga is doing, is investing a lot into sustainability and being a good corporate citizen. Within that is helping to educate the next generation of people.  So we asked Chuck what he thought about young people’s skill sets and what they should be learning if they want to attach their career to the clinical research organizations, especially taking the virtual stuff into account. 

Chuck pointed out that they need to think about what it is they bring to the table that is of value in any role, within the CRO or clinical study space.  Chuck shared that “We actually have a doctor on staff, who is quite savvy in technology and that has proven to be very valuable for us. A nutritionist on staff also is very savvy in technology. When I really think about it, there are three core things”.

Number one is to have enough of an understanding of the science behind the clinical trials; the biology element of it. It becomes key to just simply know how to read the protocol. No matter where you are in a clinical trial, this is important. And many people, as you know, haven’t even looked at the protocol, even if they’re actually in a clinical trial. It’s the governing document for how trials are run, so understanding the biology associated with it is very key.

Then, number two is understanding technology, not the way those of you in tech understand it or developers understand it, but just the basics of technology like:  how is it used, how does it work, and how does it affect running a clinical trial. It becomes important. Not everyone who graduates is technologically savvy, as much as we would think all young people are; and the reality of it is that some people don’t spend the time to become savvy.  Being good with social media, doesn’t mean you are good at technology. 

  The last one, from a hard skills perspective, is really centered around the data science world. Chuck wasn’t talking about being a data scientist, but at least people need to understand the power that can be derived from data and how it fits into the first two points above, and ultimately what goes on in a clinical trial. 

Those are the three areas that Chuck thinks anyone coming out of college, who’s interested in getting into this space, should have at some level. If you come in and you’re going to be involved in the solution area within a CRO or a clinical trial space lifecycle, then obviously you should have stronger technology experience, but you should also understand the biology.  And, you could just flip any one of these skill sets, as to where the emphasis is, but don’t ignore the other two. 

Those of us who have been around awhile see that this industry is definitely trying to change, It wants to change, but it is slow to change. We’ve seen this through some of the events that have occurred in the past, like in the EDC world. Some of it has to do with the regulations and some of it is because change is hard; it’s complex, so therefore it is hard. 

The more people coming out of college and entering into this industry, that are willing to embrace change, challenge the status quo, and really lead and fuel change, the more valuable they will be in the industry; and this is not unique from other industries but more important in this industry, especially drug development at large. 

 

Compliance and regulations impacting clinical trials

We have been seeing it get better, but the name of this session, ‘the pain of change’ is accurate. You know the saying “if the pain of staying the same is greater than the pain of change, change will happen”. So we are clearly in that situation right now. 

Yes, the regulations are changing now. We just don’t have a choice, it must change.  Across the board, whether it is to move to VCT or more virtualization, or it is to change the regulations, clearly that is an absolute necessity right now.  Chuck sees a couple of factors, although he doesn’t proclaim to have expertise in all the regulations, but he does have enough of an appreciation of it all to share some insight. 

First, there are regulations, whether it’s about the data privacy or what you have to do to comply with e-consent, or the qualification of the patient to be a subject in a clinical trial. Clearly all of those things have to be loosened up a little bit with a very reasonable sense of what is real risk and what we deal with. But also, what is the real risk of not embracing the use of a fit bit versus having to develop a “brand new” fit bit for use specifically in clinical trials. 

Then the other piece of it is really the interpretation of regulations, relates Chuck. As we all know, how companies go about interpreting them is different. They could be interpreting them in an extreme sense, that results in the rock around your neck. Or, they could be interpreted in an appropriate way, whereby there is more freedom there than we realize, but that means that companies have to take a little more risk in order for them to embrace that change.

Those 2 factors are really driving it, as clinical trials are regulated in many ways.  The sites are regulated, the monitoring devices are regulated, the software is regulated, the process is regulated, and the training is regulated. 

However, Chuck says he is hopeful.  “Back to the people I listed earlier, I see all of them being incredibly influential with the FDA these days in helping the FDA to make the changes and to realize those changes, in terms of what the regulations are for and how clinical trials can be run differently”. In the end this is a good thing and the industry needs more of it.

 

Likely future for the industry

We asked Chuck to look into his crystal ball and tell us what he expects to see next.  Of course no one expected this virus, but looking at technology and the value of quantum computing, we could easily be moving from wearables to implantables; like the Borg in the Star Trek TV series. But honestly, we all can imagine that in the future, implantables will actually be the case.  

As this was discussed, Chuck took us back to the example of a patient sitting in their house. The patient needs to understand things like, ‘How do I take my blood pressure?’ The reality of it is that these often mundane things add up and make change difficult and clumsy, and not effective. Again, an older person who’s not as computer savvy or technically savvy as others may be, is a great place for us to introduce augmented reality or virtual reality. We could help guide them through everything through the use of intelligence. With a small laugh, Chuck said “I know this is not really the sexy stuff”, just simply helping the patient, or for that matter helping the participant in the clinical trial. It is an unprecedented business opportunity to help them all to really understand a different way to do things and to embrace change.  

Another space for change is where we are more and more paperless, like EDC and EMR systems and the intersection of these worlds. Now, even more data is available as you virtualize or hybridize in patient-centric clinical trials.  This intersection of clinical science and data science is what Chuck sees happening more. For example, acquisitions that are going on with companies buying one another, like the merger of Quintiles Transnational and IMS Health. The industry is watching all this. 

Chuck leaves us with a question, “But then what’s next?”  So now we have some good data science being applied to better interpret all this data, and the use of AI, which also fuels the opportunity for using more AI, can help improve these complex processes in clinical trials, as well as some of the logistics that were mentioned earlier. For example, finding inaccurate data actually as it is being captured, and then taking immediate action. There are huge opportunities out there and Chuck believes that this is the direction where things are going to go in the short term, before we start to cut people open and put sensors inside of them.

→ Watch PharmaTech webinar on virtual clinical trials here.

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