Virtual Trials and COVID-19: Ensuring Patient Safety and Data Quality

Tell the audience a little bit about yourself.I’m currently at TriNetX as the Senior Vice President of Clinical Science and Operations, but I’ve been in the clinical and life sciences industry for 22 years. Throughout my experience, I realized a big piece missing in using data to better clinical research was patient-level data. About five and a half years ago, TriNetX came to me and I realized this was a new company up to great things, including using data to advance clinical trial research and planning.For our audience members who aren’t familiar with TriNetX, can you share a little bit about the organization and what role it plays in the clinical research ecosystem?TriNetX was founded in 2013 and commercially launched in early 2016. We are a global health research network and SaaS, on-demand patient data platform that includes advanced analytics and downloadable data sets. We connect the life sciences industry to patient data around the world and provide rapid insight generation to clinical and medical publications to advance thought leadership. We like to tell our customers, “Welcome to the revolution” - our mission is to help conduct trials that are faster and more efficient, so we can bring drugs to market faster and treat patients more quickly than they would have been otherwise.Looking back three to five years ago, there was some criticism of the non-global nature of real world evidence. Has TriNetX responded to these concerns and, if so, can you tell us how?It’s amazing how far we’ve come. Five years ago, TriNetX only had US data, but we knew early on that this wasn’t going to be enough. So, we set our sights on expanding outside the US, first targeting the EU, then the Asia-Pacific region and Latin America. This expansion, with the goal of building a network of data that is truly global, is very important to TriNetX.I’m sure capturing this data at a global scale comes with complications. Have you faced any challenges throughout this expansion?It hasn’t been an easy task to expand. The biggest challenge is how to get global data quickly. Our strategy has included organic growth of our network of sites outside the US, followed by inorganic growth through acquisition of Custodix, the “TriNetX of Europe,” in 2018. Over time, we’ve continued to expand our global footprint in every way; not just through our network, but through our employees, too. We’ve found it’s important to have boots on the ground around the world.Have you seen sponsor motivation to use real world data change over the last few years in response to changes like capturing more global data?We’re getting more and more requests for data outside the US on a daily basis. It’s still hard to come by this data, but there’s a high demand for global data that allows sponsors to optimize trials for patients, sites and PIs, or generate real world evidence of how drugs are being used in different countries.How can real world data help the industry address ongoing issues with representation of diverse patient populations in clinical research?Over the last few months, TriNetX has put an exceptional focus on diversity and inclusion in data. We believe real world data can provide a better understanding of all patient populations across various stratifications including age distribution, race and ethnicity, comorbidity, geography, and more. Sponsors can use real world data to expand their trials and pick sites that have more diverse populations of interest that would still be eligible for the study. They can also explore populations that may not be studied in randomized clinical trials, and how they’re using drugs and reacting to treatments in the real world. Having all this data and a large number of patients in observational studies is helpful for both trial optimization and trial design.According to ERT research, as of last July, 82% of sponsors had adopted some type of virtual trial technologies into their studies. Does TriNetX have a role to play in helping sponsors run effective virtual or hybrid trials?Yes! We’re heavily engaged with many sponsors to address the expanded demand for virtual and decentralized trials. We can work with healthcare organizations to do virtual and hybrid trials, but also use our data to help clients with external control arms, retrospective and prospective observational studies, parallel arms, and dynamic cohort studies (examining the incidence of a condition within patient populations.) These efforts can happen alongside randomized clinical trials, but demonstrate other ways of conducting studies that don’t involve enrolling patients in the old-fashioned way.Do you have any final thoughts you’d like to share with our audience?I think we’re progressing well as an industry in terms of recognizing the power of real world data and what it can do. I encourage everybody listening to do what they can to unlock more real world data and make it usable for our industry. Regulators are now accepting more real world evidence submissions and providing more guidelines on how to do it appropriately. From patients and healthcare organizations, we need more access to data, given it’s all provided with consent and in a de-identified manner. If we, as patients, all allow our data to be used, it’ll allow for bigger research populations, make studies less costly compared to RCTs, and ultimately help reduce drug costs. Using more and more data in research whenever possible is the most ethically sound way to keep moving drug development forward.

Tell us about your experience.After I finished medical school/neurology training, I started on faculty at Indiana University, School of Medicine in the neurology department. I ran a few clinical trials during my time there and became increasingly interested in clinical trial design. Beginning in 1998, I went to work at Eli Lilly and Co. where I focused on late phase work and worked primarily on Alzheimer’s. I started this consulting business about three years ago, and Cogstate was one of the first companies I started consulting with.For our listeners who aren’t as familiar with Alzheimer’s disease, can you explain the specific diagnosis versus one of dementia or mild cognitive impairment?Alzheimer’s is the most common of what we call neurodegenerative diseases; in other words, diseases where brain cells are slowly dying. Alzheimer’s is the most common cause of dementia, but isn’t the only kind of dementia. Recently, the development of biomarkers has allowed clinicians to evaluate if people have the classic pathology to diagnose Alzheimer’s without an autopsy. It turns out, for Alzheimer’s and neurodegenerative diseases you have pathology for many years before you have symptoms. For Alzheimer’s in particular, one of the most important pieces of pathology are amyloid plaques. These plaques are present in the brain for 15-20 years before the onset of any symptoms. After developing these plaques, people develop what’s called mild cognitive impairment which means they experience changes in cognition, but do not meet the strict criteria for dementia. Eventually, people move into mild, moderate, and severe dementia.We know that 50 million people worldwide have dementia and as you state, Alzheimer’s contributes to about two-thirds of cases. Can you tell us a bit more about the current state of Alzheimer’s research?Alzheimer's disease research began with Dr. Alzheimer in 1906, but drug treatment got started in 1990. The first drug approval for Alzheimer’s was a drug called Tacrine in 1993, but this was taken off the market due to causing liver problems. The last new drug approval for Alzheimer’s came in 2003. These medicines are really used to treat the symptoms of the disease. They don’t get at the underlying pathology of the disease. For the last several years, researchers have been more focused on what are typically called disease modifying drugs, which get at the underlying pathology of Alzheimer’s. 99.6% of all Alzheimer's trials fail. Do you think the high failure rates of these trials scare sponsors and prevent them from wanting to invest?That’s been a bit of a rollercoaster. At times, I think that has been the case. There’s a huge unmet need for Alzheimer's research as it is the sixth leading cause of death in the United States. Since we are an aging population, the population growth we will experience will cause the cost of Medicare in the United States to be a trillion dollars a year. Pharmaceutical companies will step up to the plate to try and meet the needs of our population. But then, as you pointed out, when we went through this period when there were so many drugs that were well studied, it just turned out they didn’t work, so there was a time when pharmaceutical companies were skittish about getting into something so risky. What has allowed us to identify these new discoveries and potential advancements in Alzheimer’s disease research?There are a number of factors that come into play. A lot of it is hard work and a lot of it takes longer than one would like. Another aspect is: what do we know about the biology of Alzheimer’s disease and how are we refining the targets? The other advancement in the field is study design. People have learned from past experiences and learned the importance of demonstrating target engagement, meaning ensuring the drug gets into the brain and does what it is supposed to do.It sounds like we may be on the verge of the first disease modifier for Alzheimer’s disease. If it gets approved in the next few months, how will that affect the perspectives on Alzheimer's disease at large?My personal perspective is that it really doesn’t matter if certain drugs are approved or not. From a scientific standpoint, the field knows that the antibodies being researched are giving us a signal. Psychologically, I think it does make a difference for a lot of people, including some of the investors.Are there any final thoughts you would like to share with our audience about Alzheimer's disease research?Yeah, just to reiterate, I think it is a really exciting time for our field. I think we are really starting to get a foothold on treatment modalities, targets, and study designs that can start leading towards more rapid successes. The limiting step in Alzheimer's disease research is recruitment into clinical trials. The only thing I would mention is that if people are having symptoms or even just have a family history, there is a study going on that could be good for you. You shouldn’t go into a clinical trial thinking that the drug will make you better. You should go into a study because people who participate in a clinical trial do better overall than people who don’t. The reason being you get fantastic medical care, you get a lot of attention paid to you, both for Alzheimer’s as well as general medical problems that may come up, and you’re doing something good for society. 

To start off, why don’t you tell us about your experience in the clinical research field and a little bit about yourself.I have had 30 years of experience as an observer of the clinical research enterprise. First, my involvement in management consulting; then I started a publishing company called Center Watch which captured a lot of data and observations about the research enterprise and published that information. After I sold Center Watch, I moved into academia and the nonprofit world and I have been there for about 20 years. Ken, I know you are quite the advocate for building clinical research awareness, and you have certainly been a reliable source of data and insightful metrics on the clinical research industry. Why do you think the general has such a distrust in the pharmaceutical industry and in pharmaceutical development in general?This is such a critical issue and is a perennial problem in the industry. This industry has had questionable practices in R&D as well as the commercial side. There are also some unethical practices that have gotten some visibility, particularly among minority community involvement in government-funded and industry-funded research. As an industry, we have not done a good job of educating patients and the public. As a result, we saw a lack of response and misalignment of messages that come from industry and the clinical research enterprise in general. If you look at the way clinical research is depicted in mass media, a lot of clinical research is depicted as studies that have gone horribly wrong with some dark or unethical practice, and that is often the kind of lesson the public gets when they learn about clinical research.Throughout the pandemic, from February to July 2020, the percentage of the US population who gave the pharmaceutical research industry positive ratings increased by 22%. Some even referred to the industry as “cool”, which is welcome but surprising to hear. Why are we seeing such an uptick on confidence now?This is a very exciting phenomenon, but we have to watch it carefully. To your point, there have been a number of global public opinion polls that have looked at a variety of sectors throughout our economy. The pharmaceutical industry being one of them, and it has enjoyed a bump in positive ratings. It is one of the only sectors where public opinion has maintained this positive bump throughout the pandemic. We think a lot of it has to do with the drug development enterprise being at center stage with a tremendous amount of public visibility. It hasn’t necessarily influenced public trust because awareness around activity rarely translates into behavior.This confidence in clinical research might be rising, but we know the industry still needs to put in the work to repair and rebuild its relationship with the minority population.I think it is widely known now that COVID-19 incidents and severity is much higher in minority communities. This is all part of broader awareness for the critical need of diversity and awareness in clinical research. If you look at a minority or a Caucasian community what you see are very high levels of awareness of clinical research. They will self report that they know what clinical research is, however, there is a significant disconnect between awareness about research and personal involvement in clinical research. Some of it has to do with distrust in clinical research and the drug development process.Really good points, and I can share some of my personal interactions in my circles. Even in the minority population there is a difference of opinion in terms of if they should take the vaccine or not. If you look at healthcare workers in the minority population they feel as though they need to take the vaccine for their own safety, but for those not in the healthcare settings they will say things such as, “I am skeptical”, or “I don’t see the need to take it because of this distrust.” So yes, there is even a difference of opinion in the minority population about how safe these vaccines are.That is such a great point! There is kind of an insular community when you’re in the healthcare environment. We forget as clinical research professionals the vast majority of the public has no real exposure to healthcare unless they’re facing the burden of disease. There are obviously a lot of complexities that come into play. I don’t want to ignore the positives we have seen because despite all that, we were able to develop multiple vaccines much quicker than anyone anticipated. How did the industry work together to make that happen?There is just so much that has happened. Clinical research is heavily regimented and methodical activity. Historically, we not only deviate from it, but we treat the way we operate in a very rigid way. The pandemic forced everyone to become much more accommodating and flexible. There was a recognition that we all need to step in together to protect patient safety. We need to conduct our research activity while helping each other succeed in this environment of high uncertainty with such a huge public health crisis. With that very accommodating and collaborative style, we saw pivoting and adaptation to embrace remote and virtual approaches where we could minimize infection to emphasize patient convenience in these approaches.It is clear that the industry definitely rose to the challenge and collaborated around this common cause. How much of this is going to last beyond the pandemic and do you have any last recommendations around how we can continue to build trust in the industry?As an observer looking in, we often watched how the research enterprise adopts changes in the way we operate and that adoption is incredibly slow. While there is a lot of hope that we will embrace some of the many ways that we have contributed to this accelerated development activity that has yielded some very exciting treatments. I think that we may end up looking at a lot of these adaptations as one time occurrences. Long-term, if we are unable to address the additional complexity that has been introduced through virtual and hybrid trial designs, we may be looking at companies that start to re-think which of the adaptations really deserve full focus and investment.

Tell us a little bit about yourself and 1nHealth.I’m kind of a cross between a life science veteran and an e-commerce veteran. I created 1nHealth based on those philosophies to answer the question, “how do you use compelling marketing to incite individuals to take action?” At 1nHealth, we are putting an advertising catalyst in front of individuals in hopes of getting them to enroll in clinical trials. Early last year, the COVID-19 pandemic was beginning to impact sponsors' ability to run clinical trials. What kinds of choices did you see them making?For the first stage, sponsors’ and CROs initial decision was to wait. The evening the NBA cancelled the season was kind of the stark flag in the sand that this year was going to be very different. After that, sponsors and CROs had to adapt and create a more robust strategy to recruit participants, thinking beyond the standard playbook of bringing participants into sites.We saw sponsors choose to go the virtual route. Did we start to see that in the patient recruitment space as well? How are patient recruitment vendors adapting to this shift to more decentralized trials?You can take the same protocol and apply a digital lense to it to get the same results. Overall, what we have seen is instead of looking at sites as the bread and butter for patient recruitment, we are seeing studies and RFPs come to us with digital as the central point to recruitment with sites as the adjunct for recruitment. How was 1nHealth able to effectively reach people throughout the pandemic? What every digital recruitment firm is going to do is put ads in front of people and hope they take some action. Here at 1nHealth, we believe that marketing around clinical trials is about starting a conversation. We are able to reach folks for clinical trials because they are what is outside the “norm” for clinical trial recruitment. Second, we are using creative content that belongs on their newsfeed or search bar. The clinical research industry has been accused of being slow to adopt AI compared to other industries. For sponsors who have found themselves turning to digital solutions in response to COVID, what advice would you give them? How should they adjust their patient recruitment strategies?The status quo does need some shaking up. In many cases sponsors are used to sticking to what is required of the participants. We want to get sponsors to think about what is going to get people to read more - it has to be about the patient when we think about what patient centricity online looks like. We want to create content that is native to the environment and gets them to take the next step. What do you think the state of patient recruitment will be after COVID-19? Do you think it will be predominantly digital or will site-based trials come back?I think it’s going to be somewhere in the middle. COVID forced us to stay in our houses for a while, and as that lifts we’ll see the requirement for sites to be part of studies still remains. I think there is a seismic shift that is happening in the push for decentralized trials. With all of that in mind, digital will become more central to trials as some trials cannot function without sites. Are there any final thoughts you would like to share with our audience?I just want to reinforce how we have an industry that is so sophisticated and technical. We need to remember that these are people who are scrolling through their feed and come across a trial ad. Sponsors need to work to throw out sterile advertising copy because the way we talk to them is what compels them to move forward in the study. 

Jim, tell us a little bit about yourself and your work at ACRP.I started my career at Eli Lilly for 24 years before moving to Quintiles, now known as IQVIA, for 5 years. After spending the following five years consulting, I became the executive director for ACRP.ACRP recently released some data on the state of the clinical trial workforce. I want to dive into what that data revealed. What trends are you seeing in clinical research career opportunities right now?Recent trends in clinical research career opportunities include a disproportionate growth rate of clinical studies compared to the size of the workforce. We believe strongly that we need to close this gap to get therapies to market as quickly as possible.What might a typical career path look like for someone entering the clinical research industry? Do you need to have a scientific background to be successful in clinical research?Right now, I'm not sure there is a typical career path. Most people who end up in clinical research typically come into their positions by chance. That lack of clarity in career entrance and development is a huge problem.In previous episodes, we’ve heard about the importance of recruiting diverse patients for clinical research. Can you speak on the importance of having a diverse workforce in clinical research as well?We feel like we can kill two birds with one stone so to speak. Growing the diversity of the workforce can in turn grow the diversity of those enrolled in clinical trials.What are the potential consequences of clinical trial growth outpacing clinical trial employment?A potential consequence of the outpace in growth between clinical studies and the workforce in clinical studies is that we won’t have enough people to conduct studies to the extent that we need them to. This will be a bottleneck in the development pipeline.What can sites, sponsors or CROs do to encourage interest in joining the clinical research industry?The more variance you have, the more likely you are to have poor quality, and unfortunately that’s the case in clinical research now. It’s critical that we begin defining competencies for positions in our industry. When we gain industry alignment around these competencies, we can begin to train individuals on them, and then validate that people actually have them. This is the only area in healthcare where there are no real standardized requirements or competencies. We need to change that.

Fabian, tell us a little bit about yourself and your experience.I’m Colombian, but I was raised in northern Virginia. I got a bilingual medical training and moved on to research after my residency. I soon realized I wasn’t keen on the monotony of regular medical practice. I ended up moving into clinical trials and research and have been in the industry ever since.You’re a key member of the SCRS’s Diversity Awareness Program. Can you tell us about your history with the program?SCRS started this program because there was a need and continues to be a need to not just raise awareness, but to do something about the lack of diverse populations that participate in clinical trials. When I heard about the idea for SCRS to focus on improving diversity, I knew that I had to be involved.What are the most important lessons you’ve learned from your participation in SCRS’s Diversity Awareness Program?When it comes to pharma sponsors of all sizes and CROs, there was a lack of awareness of the issue of diversity. Many people I spoke to did not know about the FDASIA (Safety and Innovation Act) Section 907, which states the importance of diversity in clinical research. I knew it was important to increase awareness of this policy, even among sponsors who I wasn’t working with, because I recognized its importance and potential to change clinical trials.What can happen when sites are greedy with their information or don’t share amongst themselves the strategies they’ve utilized to improve diversity?There’s no point in having “gold nuggets” of information if they aren’t shared. The reason we do clinical trials is to improve medicine and one day we or someone we care about may need that drug. So if we’re successful at a task, we need to share what we’ve learned so other people can take something away from our successes and our failures. Passing on those gold nuggets is critical to improving our work overall.Can you tell us a little bit about the FDA Snapshots website?This website tells you what drug was recently approved and breaks down the demographics of the participants. What we can take away from this information is that if the medication was not tested on a diverse population, it may not work on every single person. And if it doesn’t work, we haven’t done our due diligence or been good scientists. This is useful because it gives us an idea of which populations we need to do a better job at targeting next time around.What can other sites do to improve the diversity of the populations they’re enrolling? Look out the window of your office, look at people in the stores, and go and understand the community that’s around you. If you aren’t seeing a reflection of that population in your patients, then there’s a disconnect that’s fixed by getting to know your neighbors and community. Meeting church leaders and business owners is a great place to start. It’s more challenging during COVID, but as businesses open up, you can go and safely introduce yourself.How can sites adapt during COVID-19 to ensure they’re still making their presence known in their communities?Still having outdoor signage to let people know you’re there is important. Because we can’t go out in the community much, we’re utilizing social media like Facebook Live to talk and engage with people in the community. We don’t want to bore them, so we connect with them by providing them with useful information on top of sharing what research we’re working on. This allows us to maintain a presence so that community members know we’re still here and ready to help.What does it really mean to have culturally competent staff at your site?Cultural competency and being aware of the nuances of different cultures is important so you don’t offend or lose anyone. I was vision screening a Vietnamese patient who didn’t know how to pronounce certain letters of the US alphabet used in the vision chart, because those letters weren’t used in her language, and shame on me for not knowing that.We need to understand what works or doesn’t work for each individual. This will help ensure they’re comfortable to engage in the study. What considerations should sites keep in mind when developing effective communications or marketing strategy to reach the patients in their communities?It’s important to know that not everyone has insurance or legal status in some communities. If you want these patients to participate, tell them they don’t need to worry about the insurance and that you’ll never share their personal information with ICE or the police. It’s critical to let them know they’re in a safe environment. Transparency on the site’s end is key because it can help patients let their guard down and even encourage their family or other members of their communities to participate. Tell us about your site and the successful (or unsuccessful) strategies you’ve implemented to make sure your patients are representative of your community.My first study was a pediatric study. I took all of my advertising money and put it into a bus campaign because I assumed all kids rode the bus. The ads ran for four months and I got three calls, none of which were from actual patients. I realized I needed to do a better job of finding the right patients. So instead, I went to daycares, talked to the parents, and started to make the right connections.If we don’t really understand our patient populations and where we can find them, it’s not going to work. It’s critical that we work on that understanding because we don’t want to waste time and efforts; we want to be good stewards of the sponsors we’re working with and be considerate of spending the marketing dollars appropriately. Tell everybody a little bit about your advocacy for health literacy and your TV show.I’ve always wanted to promote health literacy. The terminology and acronyms that we don’t think twice about can be confusing for people outside the industry – and not just that, but also for people from outside the country or culture.To accomplish my goal of educating the community, we started the Emerson Diversity Health Foundation. It’s designed to provide community outreach and education awareness. We partnered with sponsors to create a TV show, “Tu Salud Tu Familia” (Your Health Your Family), that’s been on for a year and a half and is now Emmy-nominated. It airs every Saturday morning and we are joined by elected officials, thought leaders from industry organizations, and patients who help us explore a health topic in simple terms. We reach 50,000 people live, and our social media presence has helped us expand our reach all across the country even though we’re a local show.Again, the success of this doesn’t just benefit me, it benefits everyone. An educated patient knows the value of healthcare and research and knows where to get access to these important resources.Watch Tu Salud Tu Familia on YouTube (English subtitles are available) or follow the show on Facebook, Instagram, and Twitter.

Fabian, tell us a little bit about yourself and your experience.I’m Colombian, but I was raised in northern Virginia. I got a bilingual medical training and moved on to research after my residency. I soon realized I wasn’t keen on the monotony of regular medical practice. I ended up moving into clinical trials and research and have been in the industry ever since.You’re a key member of the SCRS’s Diversity Awareness Program. Can you tell us about your history with the program?SCRS started this program because there was a need and continues to be a need to not just raise awareness, but to do something about the lack of diverse populations that participate in clinical trials. When I heard about the idea for SCRS to focus on improving diversity, I knew that I had to be involved.What are the most important lessons you’ve learned from your participation in SCRS’s Diversity Awareness Program?When it comes to pharma sponsors of all sizes and CROs, there was a lack of awareness of the issue of diversity. Many people I spoke to did not know about the FDASIA (Safety and Innovation Act) Section 907, which states the importance of diversity in clinical research. I knew it was important to increase awareness of this policy, even among sponsors who I wasn’t working with, because I recognized its importance and potential to change clinical trials.What can happen when sites are greedy with their information or don’t share amongst themselves the strategies they’ve utilized to improve diversity?There’s no point in having “gold nuggets” of information if they aren’t shared. The reason we do clinical trials is to improve medicine and one day we or someone we care about may need that drug. So if we’re successful at a task, we need to share what we’ve learned so other people can take something away from our successes and our failures. Passing on those gold nuggets is critical to improving our work overall.Can you tell us a little bit about the FDA Snapshots website?This website tells you what drug was recently approved and breaks down the demographics of the participants. What we can take away from this information is that if the medication was not tested on a diverse population, it may not work on every single person. And if it doesn’t work, we haven’t done our due diligence or been good scientists. This is useful because it gives us an idea of which populations we need to do a better job at targeting next time around.What can other sites do to improve the diversity of the populations they’re enrolling? Subscribe to learn more. Get access to the full episode by signing up for our mailing list at Trial Better.How can sites adapt during COVID-19 to ensure they’re still making their presence known in their communities?Subscribe to learn more. Get access to the full episode by signing up for our mailing list at Trial Better.What does it really mean to have culturally competent staff at your site?Subscribe to learn more. Get access to the full episode by signing up for our mailing list at Trial Better. What considerations should sites keep in mind when developing effective communications or marketing strategy to reach the patients in their communities?Subscribe to learn more. Get access to the full episode by signing up for our mailing list at Trial Better. Tell us about your site and the successful (or unsuccessful) strategies you’ve implemented to make sure your patients are representative of your community.Subscribe to learn more. Get access to the full episode by signing up for our mailing list at Trial Better. Tell everybody a little bit about your advocacy for health literacy and your TV show.Subscribe to learn more. Get access to the full episode by signing up for our mailing list at Trial Better.

Host Jason Eger is joined by Dr. Diana Foster, Vice President of Strategy and Special Projects at the Society for Clinical Research Sites, to discuss how clinical research sites can help the industry improve patient diversity in clinical research.

Tell us about TrialScope and your experience.I am the Vice President of Patient Engagement at TrialScope. I used to work at the Michael J. Fox Foundation for Parkinson’s Research and also had my own company, Clinical Trial Connect, before it was acquired by TrialScope last year. I’ve been working in the clinical trial recruitment world for the past ten years. I am overseeing a new product called TrialScope Connect, which sets sponsors up for success when it comes to clinical trial improvements. What typically motivates patients in a clinical trial?Every patient is different and every trial is different. People are dealing with diseases that are often very urgent or difficult. Having a path towards a better prognosis, extending your life, and improving your quality of life are all factors that people consider when it comes to clinical trials. There are people who participate in clinical trials who know it might not improve their quality of life, but it’s something they want to do for the next generation. For other people, there is an awareness in recognizing no cure has ever come on the drug shelves without going through the clinical trial process, and they want to do their part to make sure science continues to move forward.Tell us about the journey of a patient in a clinical trial.The journey starts when a patient is first diagnosed with a condition, but following that, there are many different places where someone might become aware of a clinical trial for the first time. At that point, patients need an educational component to become familiar with the different terminology. Once a patient has that knowledge, they can decide if they are interested in moving forward and participating in research. Then, they have to find the right trial for them. Every trial is different and has different inclusion and exclusion criteria. Every trial is run at different site locations. There is a challenge around finding the right opportunities. Once a patient does identify an opportunity, getting in touch with that site is the next step. Then they go through the enrollment process. Ultimately, a patient will learn if they are eligible to participate in that trial. If not, they’ll have to restart their search process.Do you see patients becoming more engaged in clinical trials and in general has this impacted clinical research?Today, people are used to being very informed. Patients are surprised when they start the journey at how analog it is and how many roadblocks exist. One of the things that is problematic is that a lot of patients don’t know how to search for a trial that is the right fit for them. There is no easy tool to solve this problem, and patients have to tediously review clinical trial listings. In addition, if patients aren’t aware of how to search proactively, they’ll never know their full range of options. This denies them an informed choice. This is how standard trial-centric matching works, where the finish line is one trial and a lot of times a funnel is used to see how many patients need to be at the top of the funnel to get to the trial’s required number of patients. What’s unfortunate is that for all of the patients that weren’t eligible there’s not a great next step of action for them. For the enrolled, they might have missed out on the opportunity to be in another trial since they were only being screened for this specific one. We think about patient centric trial matching, putting the patient in the middle and asking what trials does this patient actually match to and allow them to make an informed decision. What can the industry do to get to this patient-centric model?There’s a lot of companies that are tackling this and whether the solution is a website or an integration, people are trying to do right by patients. It’s an opportunity to standardize how we talk about eligibility criteria and the benefit is that companies don’t have to reinvent the wheel. With TrialScope, they can now have a best-in-class platform to match a patient to all the trials that are a good fit for them.What can sponsors do to motivate and educate the recruiters of their trials? How do we get them to be more knowledgeable about the trials that are out there?The physicians are challenging. They have 15 minutes or less with a patient. Anything that is disruptive to their flow or takes up more time is something they aren’t going to use. However, there is a solution where they can help the patient to make a decision that is within the time of their appointment. Patients can review their matches in advance, get material in the waiting room, and by the time they’re with their doctor they have a decision and are fully informed. Now, the doctor can talk to them about that specific trial. A lot of solutions like that are possible.How do sponsors ensure that they are being mindful throughout the patient’s journey during all of the phases?Something that happens is that patients spend a lot of time reviewing their matches and they never hear back from the site.  Sponsors can be more communicative with patients, even in an automated way, to let them know when a site has stopped recruiting. Let’s make sure no patient goes down a dead end and is waiting for a response that they’ll never get.For the people that do enroll, the journey continues for them. A lot of times patients don’t know what happened with the trial. Making plain language summaries available in different languages and sharing patient data with those who participated in the trial can be steps towards increasing patient satisfaction with their trial experiences.

Speaking from a general safety perspective, as well as a cardiac safety perspective, what challenges have you observed in clinical trials resulting from the COVID-19 pandemic? [3:07]I speak for myself and others, no one trained us for this and we had to quickly react. We want to ensure the safety of the participant as well as making sure the data is right. We have to consider what is in the best interest of the patient and how we can ensure that the data that is collected will be able to be analyzed at the end of the study. We had to rethink what to do, but the situation differs. For a company in Phase I with very little information, it’s not the same as a Phase IV clinical study. However, the common ground is that they try their best to maintain the integrity of the trial. In particular with cardiac safety, there are certain parts of the clinical trial where remote monitoring can continue to be done.What approaches have you seen employed in managing these challenges? [8:40]What I see the most is that one size does not fit all. Certain studies you cannot stop. Overall, what we have been trying to do is hold a very careful assessment of the conditions of the patients under study and the risks vs. the benefits of stopping or continuing the study. Thinking back, what do you think was the general consensus in the industry with respect to virtual clinic trials one year ago, versus today?  Was this something under discussion?  If so, how was it meant to be applied, versus what are you seeing now, and versus what we may see in the future? [12:00]One year ago virtual trials was an interesting topic that needed to be further developed and was worth discussing. Now, it is something that we jumped into in order to ensure trial integrity and safety of the patient. What do you do when you’re in the middle of a study and you realize you cannot collect that data and if you want to complete the study, changes have to be made? If you were supposed to collect the data in a certain way at a certain location, now you have to modify what you had done before in order to ensure the safety of the patient and the accuracy of the data. Virtual studies was no longer an idea, but an urgent need that had to be implemented immediately.As we adapt to the current paradigm, certain changes are occurring in the way we all operate. There’s a lot of talk now of a hybrid model in clinical trials as a means to continue studies during this pandemic. Of these changes, what do you see as temporary, versus a change reflective of the future of safety monitoring in clinical trials? [17:48]During these times we are getting a crash course on things like digital collection of many different outcomes and safety monitoring that in the past we were underusing or didn’t know how to properly implement. This is pushing us to better define, monitor and focus on the essentials in clinical studies. If we can make it easier for patients to be a part of clinical studies, there might be a higher participation of people that want to volunteer. If we can take advantage of the tools that we currently have available and the others that are yet to be developed, there will be more real life data. From the patient's perspective, do you have any thoughts as to how they might view clinical trial participation in context of the COVID-19 pandemic? [20:33]If you can ensure patient safety and can communicate that the setting that’s been set up in a study is ensuring safety for them, that will make them feel reassured. We are making it easier for them to complete the different assessments. In order to do so, there has to be adequate training to ensure the safety of the patients and adequate data is collected.