COVID-19 & Strategies for Successful Vaccine Trials
ERT’s Jason Eger, Nadeeka Dias, and Chris Watson explore technology-based solutions for the challenges of vaccine trials and address the biggest issue facing the clinical research community today: COVID-19.
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Nadeeka Dias and Chris Watson from ERT discuss the race for a coronavirus vaccine and take a deeper dive into how sponsors and CROs can use technology to address the unique challenges of vaccine trials.
What are the specific challenges sponsors face in trying to create a COVID-19 vaccine? [02:10]
The real challenge is that the threat is now, so time is not on our side. However, good clinical research takes time. Because there are currently no approved vaccines or treatments for COVID-19, researchers are working on two types of trials: trials to test treatments for patients who already have the disease and trials to test a COVID-19 vaccine.
Even though these vaccine trials are accelerated and researchers and the FDA are moving quickly, it’s still going to take a lot of time to find a vaccine that works. While collecting data in a COVID-19 vaccine trial is going to be similar to any other vaccine trial, patient recruitment will be harder and sponsors will have to ensure that patients who are enrolled aren’t asymptomatic.
What are the challenges that are unique to vaccine trials? [04:21]
Vaccine trials are often developed in response to a new plague. Because of this, clinical development teams need to collaborate quickly to mitigate trial risks and delays. These studies also require a lot of physician oversight of patient safety and adverse events. Additionally, because vaccine trials often enroll large numbers of healthy volunteers across diverse demographics, it’s important to be mindful about how sponsors will effectively collect a very large volume of data. Lastly, sponsors should consider how they can keep their patients engaged, especially as the vaccine trial transitions into a more observational phase.
What are the challenges of using paper in vaccine trials? [06:05]
Because paper is a quick way to respond to the needs of vaccine studies, paper has always been the default option for data collection in these trials. What isn’t always taken into account is the volume of data that will need to be transcribed from paper into a repository; a typical vaccine trial can produce millions of data points. This volume of data should convince sponsors to contemplate using electronic data collection.
What advice would you give sponsors still using paper in their vaccine trials?[07:27]
It’s important to consider the impact of still using paper not just on data collection but on data analysis. If all of the data is regularly uploaded into an electronic database, the sponsor will likely be able to get results quicker and achieve database lock sooner compared to using paper. An electronic platform also provides real-time access to patient data, making it easier for clinicians to monitor patient safety.
How can sponsors already using a digital solution improve their data collection?[08:45]
Electronic always gives you better data quality, but to maximize it, you need to remember the end user: the patient. Engage with patients and facilitate their journey within the clinical space so ultimately they’re providing the quality data you need to determine the results of the study.
Flexible provisioning or BYOD is an electronic solution that makes electronic data capture very affordable for vaccine studies and integrates well into the everyday lives of patients.
How can a sponsor get started with electronic data collection?[10:59]
If sponsors have reservations about starting to collect data electronically, they can always run a small pilot study in one particular territory using these techniques. Comparing the results in that territory to results in the others should make it clear whether or not a sponsor should pursue electronic data collection in their studies.
Once this data is collected, what tools are out there for sponsors to use to help them analyze and visualize the results?[12:15]
Instead of putting data into the system at the end of a study (as is done with paper data collection), data is added to the system throughout the study. A strong reporting platform that can support analysis of millions of data points and give you early insights into how the vaccine is progressing is critical.
What are the ways we can use digital to keep healthy volunteers engaged in vaccine trials?[13:25]
Incorporating technology into a well thought-out study design can improve long-term patient engagement. A key motivator for patients is knowing that a clinician is reviewing the information they’re entering in their diaries. A digital solution can be beneficial here; concerning data can be quickly flagged and sites can easily maintain communication with patients.
Any final thoughts?[15:15]
The circumstances we’re in are unprecedented, but there are many brilliant people working together to discover treatments and vaccines. It’s important that the industry support these studies by implementing known and established best practices for data collection.
The search for a COVID-19 vaccine and cure is an ideal opportunity to embrace, not fear, the use of technology in clinical research. The patients and healthy individuals who want to be involved in these trials are embracing technology themselves; sponsors should follow their lead.
Introduction Speaker: Technology is out there. This is an idea, an opportunity to facilitate the use of technology into studies, and actually not be scared of technology because the patients that we’re trying to reach for, those individuals we want to be involved in the vaccine studies. They are readily embracing technology.
[Intro]: Welcome back to Trial Better. In this episode, we discuss the race to find a COVID-19 vaccine and the important role technology plays in data collection for vaccine trials. When time is of the essence and patients are forced to stay at home digital solutions and engaging technology may be the key to continuing successful clinical research. Leading this conversation is host Jason Edgar; guest, Nadeeka Dias and Chris Watson of ERT. So let’s not waste time and jump into this edition of trial better.
Jason Eger: Hi, everyone. Welcome to another episode of ERTs trial better podcast. I’m your host, Jason Eger and today’s episode I’m joined by ERT’s own Nadeeka Dias, senior clinical science advisor, and Chris Watson director of product management. Nadeeka, Chris, welcome to the show. Nadeeka, why don’t you tell us a little bit about yourself and a little bit about your background?
Nadeeka Dias: Sure. Yeah. So I’ve been working in health technology and clinical trials for several years now and I specialize in electronic clinical outcome assessments or eCOA across several therapeutic areas and I often provide scientific regulatory and technology use guidance to sponsors related to clinical trial end points as well as how to collect high quality data.
Jason Eger: Great. Glad you’re here; Chris, yourself?
Nadeeka Dias: Yeah, certainly. I’ve been working in the technology space now for over 20 years, the last 12 of which I’ve been focusing within the clinical space where I’ve been utilizing my experience of looking outside of the box, trying to identify new technologies that can be brought into the clinical arena to facilitate the capture of quality information from our patients out there in the field.
Jason Eger: Great. Thank you. I know that you both have worked a lot specifically with vaccine trials, so Nadeeka, why don’t we start with you, in your mind what are some specific challenges that sponsors might face in really trying to get to a COVID-19 vaccine?
Nadeeka Dias: Yeah, so the real challenge right now with this novel coronavirus is that the threat is now, more and more people are falling ill every single day. So time is not on our side and good clinical research really takes time. So, you know, there’s no currently approved vaccine or treatments for COVID-19. So researchers are working very hard on really two types of clinical trials right now. So the first studies are aiming to test treatments for patients who already have the disease to hopefully reduce severity of symptoms. And, you know, these studies are important because they can buy us some more time for the other set of trials, which are testing the vaccines specifically for COVID-19. There’s a lot of pressure right now for these vaccine trials to get up and running as soon as possible. The FDA is reviewing submissions very quickly because it will still take a great deal of time to collect the appropriate amount of data running through multiple phases of human trials, to really know whether a vaccine is safe and effective.
Fundamentally the collection of data for COVID-19 vaccine will be similar to other vaccine trials, but patient recruitment will likely be harder during this time of shelter in place and quarantine and also making sure that these enrolled patients are not asymptomatic. So really, I mean, overall they’re challenges for researchers also at early stages at these early stages to know what the true immune response will look like for COVID-19 thinking about what the appropriate study design should be and will it just require one dose or multiple. So a lot of things to really think about and kind of our hurdles during this attempt to find a vaccine for COVID-19.
Jason Eger: You mentioned the challenges kind of in general, are there certain specific ones that are unique to vaccine trials that people kind of should be looking out for now?
Nadeeka Dias: Yeah, well, so the vaccine trials in general are unique because they’re often developed in response to a new threat. So just like now, so things are moving very fast and because of this clinical development teams must collaborate very quickly to develop timeline scenarios in order to mitigate any risks that are associated with say delayed site openings and first patient in, these studies also require a lot more physician oversight as well. Safety to consider and so it’s important to monitor adverse events, such as redness, swelling, body temperature on a daily basis to see how each patient is responding to the vaccine dose. One other thing with vaccine trials is that they often enrol a very large number of healthy volunteers, numbers that are often in the thousands once you reach a phase three trial. So these patient populations are also very diverse with wide age ranges and they’re living all over the world. So it’s important to be mindful about how sponsors collect this high volume of data, as well as how to keep these patients engaged. This is especially important as the trial transitions into a more observational phase testing the effectiveness of the vaccine in the real world.
Jason Eger: Chris, with that and Nadeeka talked a little bit about the volume of patients that are in these vaccine trials. What are some of the challenges just using paper in vaccine trials?
Chris Watson: When you think about paper, paper is often thought of as the default option for data collection of vaccine studies, paper is often thought of as a quick way of facilitating and responding to the needs of vaccine studies. However, what isn’t always taken into account is actually the volume of data that is going to need to be transcribed from paper into some source repository. I mean, for example, if you imagine a two dose vaccine study, which is generally based with 11 question daily diary, and that daily diary happens over 30 days, and as Nadeeka said, you’ve got a large volume of patients. So say we’ve got 10,000 patients, for example, that ultimately equates to 6.6 million individual data points that are being collected on paper. Those 6.6 million data points need to be transcribed into an electronic system. So they can actually then be analysed and then actually put into the ESOF ready for submission to the regulatory agencies. It’s often this factor here, when you look at the volume of data, it’s going to be captured that she should sway you away from going from paper to actually then contemplate utilizing electronic as a way of effectively capturing that information.
Jason Eger: Yeah. I mean, it makes sense, but Nadeeka, I’m sure there are still plenty of people still using paper. What advice would you give to sponsors who quite frankly, at this point, who have stopped using paper in their vaccine trials?
Nadeeka Dias: Yeah. So it’s also important to think about all the analysis involved with paper and as Chris mentioned, there’s challenges of timely and accurate entry of paper diaries into a database. So if all of this data is regularly uploaded to the database from day one, because it’s on an electronic platform, the sponsor will likely be able to get their results much quicker and help reach database locks sooner, which will be extremely valuable for novel corona virus trials. I think as we’re seeing now, COVID-19 has greatly impacted how sponsors and sites conduct study visits and clinical trials by moving toward more digital options across all therapeutic areas. With vaccine trials, which have such a strong focus on safety and monitoring of adverse symptoms, an electronic platform can provide real time access to patient data, which will be a much easier way for a clinician to provide oversight to multiple patients at once.
Jason Eger: So Chris, as we talked and Nadeeka talked a little bit about the paper solutions, what can a sponsor do now if they’ve got a digital solution in place, can they do to improve their data collection?
Chris Watson: When it comes down to utilize electronic solutions for the collection of data, as Nadeeka says, electronic gives you better data quality, but you’ve always got to remember who the end user is. What I mean by this is the end user is the patient and providing technology for them to supply the information let’s engage your patients, let’s actually facilitate their journey within the actual clinical space. Let’s find ways of engaging with them. Let’s find ways of actually maybe toning down the reminders because when they’re collecting a 11 questionnaire, 11 question diary on a daily basis, over a 30 day period, let’s use technology to understand how compliant they are, how readily they are submitting data and let’s not necessarily perpetually remind them to do the daily tasks that they actually currently are doing that. So it’s all about using technology to facilitate that engagement with the patient. So you actually, you keep the patient engaged with this study so that ultimately they are providing you the quality data is required for you to then determine the results of that study.
Nadeeka Dias: Yeah. And flexible provisioning is another electronic solution that falls hand in hand with that. Because this is approach that can also make electronic data capture very affordable for vaccine studies and by flexible, I mean that the trial would enable the use of the patient’s own devices also known as bring your own device or BYOD and then when it’s suitable, this would be alongside the use of provision devices. So this approach puts that patient at the center of the study because they can now report symptoms on their own phone. And then it helps improve the patient’s experience in the trial by integrating their study participation into their everyday lives.
Jason Eger: And as we’re all staying home right now, you talked a little bit earlier about the minimizing patient and investigator contact. So we’ve got that and as you said, Nadeeka, I mean, the BYOD allows it to be rolled out in a little bit more simple fashion if you will. So Chris, if a sponsor was thinking about it, how would they get started with electronic data collection?
Chris Watson: Obviously the adoption or technology into any offering can create some reservations and the transition from paper to electronic can seem daunting to most sponsors there. What I would recommend is if you’re having reservations about how technology is going to influence the behavior in your study, we are in a small pilot study as a subset of your main study and use electronic in one particular territory, by using one particular territory that helps you too minimize potential biases and nuances that may be associated with languages and such, because for that, it gives you a more structured and targeted data sets. Then ultimately once all the data has been collected, compare the results and we are confident that going electronic will show you the positive results and we know from previous experience with sponsors, sponsors when they’ve actually undertaken these small sub studies, the results of which have actually confounded them. They get the database a lot quicker. The data is actually residing in electronic format there and actually that enables them to actually then build out the business case to say, you know what? I need to move away from paper now, I need to bring more electronic means into my clinical research environment.
Jason Eger: So Chris, once they’ve gotten started, I mean, even if they take your advice just, as you said, they’re starting in a small territory. They’re just even looking, even in that case, how to sponsors, are there tools out there that they can use to visualize the data to see that the collection of the data is, is successful?
Chris Watson: Yeah. So, I mean, that’s fundamental across the board, now that I’m thinking about it. Where going electronic the data is into the system far faster than would be done by paper because the paper is done at the end, by having the data into system earlier, you need a tool which you can then use to visualize that data. So you can actually have reporting some intelligence Bureau at that. Well, you actually then can look at the mind and understand that data. So you’d want ultimately to have the ability to share the study progress, understand what is actually happening for to get that early insight into how the vaccine is actually progressing. Then I would recommend that whatever you’re doing there ensure that whatever service you’ve got there, they have a rigid, strong reporting platform that can support that analysis of that data.
Jason Eger: Nadeeka, with that, we talked about using electronic to collect the data. What other ways can we use the technology to really keep healthy volunteers engaged in a vaccine trial, I guess?
Nadeeka Dias: Yeah. So technology and well thought out study design are really important when thinking about patient engagement. So it’s good to incorporate several time points in which the site is checking in with the patient. And then also you know, the patient diary having that being required to be completed at certain times is a good way to keep patients engaged in the trial and you can use several techniques like on-device alarms or text reminders to encourage compliance as well. Last year we did a study with over a thousand individuals in the general public, and we asked them what types of things would help them stay engaged in a clinical study and one of the key motivators for individuals was knowing that a clinician was overseeing all of their data that was being entered so that it’s not all being forgotten once it’s entered into the diary and this is where a digital solution can be really beneficial. Because in the event, a patient enters information that might be of clinical concern, this type of thing can be flagged and the site can follow up really quickly. So it’s really a good maintenance of communication between the site and the patient. Instead of an alternate scenario where there’s this information on a piece of paper, and it’s just kind of sitting there until the next site visit.
Jason Eger: It’s very interesting. I mean, people want to see purpose behind their data, human factor wise. I mean, I think it says a lot about what we do in collecting that data and making sure we use it to find and cater to results. With that, Nadeeka, before we end this podcast, any final thoughts you’d like to share with the audience?
Nadeeka Dias: Yeah. So there is already one novel coronavirus vaccine underway a trial and with that many, many more will follow in the coming months. So these are certainly unprecedented circumstances, but there are many brilliant people working together right now to help discover treatments and hopefully eradicate this virus one day. So it’s important to support these studies with the best practices that we implement now today, and that we know that work in any way possible.
Jason Eger: Great. Thank you, Chris. How about you? Any final thoughts you’d like to share with the audience?
Chris Watson: I would definitely say that in the COVID world, as I would like to call it there, it’s amazing how technology has rapped or been adopted to facilitate how people can communicate in the locked down world that we are currently living in. This need for technology and this need to communicate across the board is now extending into the vaccines arena and the clinical trial arena there. I just hope that the adoption that we’re seeing in technology as that can be expanded more into clinical surgery and then specifically put in place to focus on how vaccine studies can be run will actually then be a new era and a new door and for how we can actually conduct clinical research in the future.
Jason Eger: Thanks to both of you, both of our experts from ERT, Chris and Nadeeka, I think you’ve really helped shed some light on how vaccine trials work and why would we use electronics in vaccine trials? It couldn’t be more important than it is right now with the COVID-19 pandemic that we’re all living through. So thank you again for both of you for being here today and we look forward to working with you, and I know you’re working with our partners in a clinical research industry to really advance toward finding a vaccine for this. So as always, we appreciate everyone joining us on Trial Better. Please make sure to engage with us at [email protected] or leave us a review on your favorite podcast channel. Thanks again, everybody for listening to Trial Better.
[Outro]: That’s a wrap special, thanks to Nadeeka, Chris and Jason for today’s discussion. As we navigate these unprecedented circumstances now more than ever, it’s important for teams to share knowledge and resources. So thank you both for sharing your invaluable expertise and thank you, the listener for tuning in. Be sure to tune in this Thursday, April 16th for our first Trial Better live session and interactive webinars series, where we dig deeper into the topics we cover on the podcast. Again, this Thursday at 11:00 AM EST, you can find information to register on trialbetter.com. Finally, please remember to comment rate or review Trial Better on Apple podcasts or your favorite podcast channel. You can also reach us [email protected] Thanks for listening and stay safe, everyone.
Sr Scientific Advisor, ERT
Nadeeka is a clinical scientist with 10 years of in-depth experience with clinical trials. At ERT, Dr. Dias provides scientific and technology guidance to global sponsors on electronic clinical outcome assessments (eCOA) across several therapeutic areas. In addition to leading the ERT Science team in thought leadership strategy, her expertise extends to COA regulatory guidance, instrument development and validation, and eCOA product/software design. She has presented numerous abstracts at global conferences and published several articles on the patient perspective in clinical trials. Nadeeka completed her Ph.D. in Neuroscience at The University of Texas Health Science Center at Houston and her Postdoctoral Fellowship at Harvard Medical School and McLean Hospital.
Director of Product Strategy, eCOA, ERT
Chris Watson is an experienced Product Strategist with 20 years’ experience in the delivery of business and consumer-based solutions, the last 10 of which have been focused within the clinical technology industry. He has an extensive knowledge of product and software development processes and is responsible for implementing the product strategy for ERT’s Digital Patient business. Chris earned his PhD in Behavioral Neurosciences from the University of Nottingham and a BSC in Pharmacology and Toxicology, with honors, from the University of Bradford, UK.