Navigating eConsent: What to Know for Successful Adoption

Dawn Strelow and Vinita Navadgi from IQVIA Technologies explore how the clinical research industry is revolutionizing patient consent. Dawn, the Associate Director of Client Engagement, and Vinita, the Senior Director of the Digital Patient Suite, discuss the nuances of eConsent and challenges faced by clinical research sites, including practical solutions and steps for successful eConsent adoption. 

Transcript

Jimmy Bechtel: 0:00

Welcome and thank you for joining the Society for Clinical Research Sites for SCRS Talks. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society. SCRS Talks allows our partners and those we work closely with to take a few minutes to address issues of industry concern, share exciting achievements, and learn more about our community. Today, we have Dawn Strelow, the associate director of client engagement and patient consent with IQVIA technologies and Vinita Navadgi, the senior director of the digital patient suite with IQVIA technologies here to talk with us about some innovative and inspiring things their organization is doing in the form of reimagining eConsent. Really excited to talk about this project and what's being done at IQVIA Technologies in this aspect because we know that eConsent is something that a lot of sites are interacting with and using on a daily basis with their sites. Dawn, Vinita, it's great to have you both. I'd love to start things off learning a little bit more about each of you. And I'll start with you, Dawn,

Dawn Strelow: 1:10

Thanks, Jimmy. So as you mentioned I'm the associate director of client engagement for IQVIA's patient consent. So what do I really do, right? That means I get to engage with sites and sponsors get. Their thoughts about the eConsent platform how it works, ideas on how to improve or enhance it. So that we best meet the sites needs, the patients needs, and the sponsors needs. And so it's a great position where I get to connect with people and have those interactions. I am a nurse by background. I worked at a large academic institution in oncology, so that gives me some insight as to the sites and what their needs are, but we obviously want to hear from the sites directly and not make assumptions about what they need, but really hear and advocate for the sites to meet their needs.

Jimmy Bechtel: 2:07

Thank you, Dawn and And Vinita, I'll turn it over to you.

Vinita Navadgi: 2:10

Thank you, Jimmy. It's a pleasure to be here today. My name is Vinita Navadgi and I'm a senior director with IQVIA responsible for IQVIA eConsent product and strategy. So what do I do in my role? Basically what we do here is try to understand what are the best features. How can we develop a product further so that it meets our users, our site users, our patients and our sponsors needs. So I work very quickly closely with Dawn and my other business counterparts to understand the requirements from the markets, from our users and build the product in a fashion that best suits them. So that's in a nutshell, everything that I do.

Jimmy Bechtel: 2:58

Excellent. Well, thank you both. And again, really excited to talk about this important topic when it comes to technology on our clinical trials for both sites and for patients. And I'd love to start off Vinita, getting a little bit of that foundation in place and hearing from you and representing IQVIA technologies. What eConsent is, how it works, and how it might differ a little bit or in a lot of ways, I guess, from traditional paper consenting processes.

Vinita Navadgi: 3:30

Absolutely, Jimmy. So, let me kind of explain eConsent by drawing a parallel with a very recent personal experience that I had, right? We just bought a house, a new house in July, and before we met with our mortgage lawyer and signed like page loads of paperwork I had walked through my house a couple of times, had professional home inspections done, and was very well aware of any functional or aesthetic gaps that existed in the house that I was buying. So there was a lot of clarity in terms of what I was getting into. Now, if I were a patient enrolling in a clinical trial, before I signed those pages, I would really know what I was getting into. What is, what would the treatment plan be like? What would be the benefits of enrolling in that clinical trial? What are the care processes? What would be the frequency of visits? The bio sample submission? What are the investigational investigations interventions that that would be undertaken? And most importantly, what is the risk that would be associated with the treatment plan? Now, this is obviously critical because it is pertaining to my health and it's an important process mandated by all the regulatory bodies around the globe. Now, traditionally, the the physician or the principal investigator and the clinical staff would provide this exact information in a verbal format to the patient. They would ask them to read the consent forms and after explaining everything then they would take physical vetting signatures on the consent forms. The original would then be stored and a copy would be sent home with the patient. Now it's very simple if you think about it, but there's a lot, it's a lot more complicated than that. Often what happens is when the patient is standing or is sitting in front of the the physician, They may or may not comprehend all the information accurately. They may have questions, but they have apprehensions asking those questions. Sometimes they can feel rushed. So there can be a feeling of being overwhelmed because they don't know what questions they have to ask when they're sitting there in front of a principal investigator. So and also the consents then have to be entered in a consent log. The papers have to be filed accurately because they need to be submitted to the regulatory bodies. Sometimes there are amendments that take place to the documents and we need to get theSignatures again on each of the documents. Dates can get missed because it's a very manual process. So there's a lot that goes in. Now what eConsent does is all this electronically. So there's a lot more organization and business process that gets set in automatically for the clinical staff and the sites. So the patient and their family, they can view the consent forms before they come in for the appointment. They can ask, or they can make a list of the questions that they may have regarding the treatment. So it gives them a lot more flexibility. And since it's an electronic version it can be embedded with pictures, videos to explain the protocol in a lot more detail. And obviously, since there's multimedia it makes it a lot more engaging. In the world that we live in it's very difficult. I mean with the attention span that we have nowadays, you really need that engaging content for patients to understand everything specifically because it pertains to their health. So and as I mentioned, amendments when they changes that come to the documents, these are automatically managed in the system. So the chances of these amendments being missed or, missing information, missing dates, all that is accurately captured because it is tracked electronically and even for monitors. When they are remotely, they can look at the information remotely in advance, and the time that they have to spend at sites reduces significantly. So it's a much more sophisticated option that is presented, there's a page by page option in which the patients can look at the information very, very systematically, move on section by section, flag any questions that they may have, and it's a very, very simplified process, I would say for both sites and patients. Also, I want to kind of address a common misconception that exists, right, between eConsent and eSignature. A lot of times it is assumed that they are one and the same. But basically, an eSignature platform will only capture electronic signatures on documents, that's it. However the eConsent platforms help our sponsors, the sites, and all the stakeholders manage the process end to end, the entire consenting process with all the documents systematically handled and it extends beyond just signatures and the objective is to support the overall consenting process in a very, very detailed and a systematic manner for all stakeholders, so the manual overheads are reduced quite significantly. So sorry for the long dialogue, but there's so much to it that I wanted to cover.

Jimmy Bechtel: 9:06

Yeah that's great, Vinita. I think, it gives our audience a real perspective on the potential benefits of eConsent, both at the site level. I think we can draw some really reasonable conclusions there, but more importantly, of course, at the patient level and some of what we're able to do. And we will contrast that. I know with some of the challenges that we need to overcome, but I think it's important for us to maintain those potential benefits in site as we seek to explore whether or not this would be valuable for our organizations and how we can bring this in to help our patients. So thank you for that thorough overview of what it means to employ eConsent at the site level. Vinita, I would also ask from the patient's perspective, then how does eConsent contribute to a more patient friendly or patient centric and accessible experience compared to a traditional consent method? I know you touched on that briefly and we could probably draw some conclusions from your previous explanation, but I'd love for you to dive into that aspect of eConsenting

Vinita Navadgi: 10:09

specifically. Now that is the most critical aspect, right? Ensuring that the patient's understanding is enhanced and converting a very long, complex, and sometimes tedious process into a more simplified, consumable, and easily digestible format. So that's the first step in getting the patients to feel comfortable in a process that can sometimes be very stressful. They're already dealing with problems related to their health and walking into something without understanding it completely can be quite it can be exhausting. It could be scary. And the objective of is by simplifying this process. Also, since there's multimedia in it, as I explained, they are able to see everything in detail in a video format or an audio format that we have interactive glossaries within our product so that if there are any tough complex medical terms, the hyperlinks provided where they can click on those and get detailed information on complex terminology. So that helps them build their confidence and improve comprehension. The next aspect that we can very easily cover is the, the accessibility. A lot of clinical trials are now either decentralized or hybrid. Which is that they offer the capability to review these ICFs both on the site as well as remotely. And this particular capability is, again, provides a lot of flexibility for the patients. The third aspect that I want to cover is the ability to support a multitude of patients, whether it's a pediatric patient, where it could, the information could be provided through cartoons, or if they're patients with learning disabilities, they're dyslexic or they have low literacy levels. The information could be provided through a narration instead of reading all the information. And if there are patients who obviously have problems with their eyesight, there's a capability to increase the font size. So there's a lot of flexibility the digital version provides that is not available in the paper version. There are also areas where there are multiple signatories involved. It's sometimes not possible for all these signatories to travel to the site to sign these documents. So there could be a legally assigned representative. There could be two parents involved. There could be a witness. And in such scenarios, you could have, maybe a signatory at site, and then there could be the other signatory who could sign remotely. So all this flexibility really creates a very convenient and an empowering experience for our patients.

Jimmy Bechtel: 13:07

That's great. Vinita. I, again, appreciate the insights into how we can make sure that, again, our patients are treated effectively. And what I really liked was the former part of your explanation, particularly in that we can make sure through eConsenting that our patients are more, we'll call it deeply or thoroughly consented into the clinical trial and have a better comprehension for exactly what it means to be part of that clinical study. I think that's really the power behind eConsent versus just simply a piece of paper. So thank you for sharing that insight.

Vinita Navadgi: 13:41

Absolutely.

Jimmy Bechtel: 13:43

Dawn, I'd like to shift over to you now and talk a little bit about some of the challenges. I think Vinita has done a fantastic job laying out the plethora of advantages or potential benefits of eConsenting, but what are some of the challenges sites specifically might face when implementing eConsent and maybe hone in because we know particularly in certain regions of the world where regulations might not allow things like electronic verification or electronic signatures.

Dawn Strelow: 14:13

Yeah, of course. So one of the biggest challenges that sites face is, being open to the use of technology for this process, right? Like, we have. And I say, we, because I've been there too, we're into this, this age old routine of using paper consent and it's a known process, right? It's solidified We know every step. We don't have to think about it really as we go through the whole process. What we do have to think about, though, with the use of technology is that it's sometimes difficult to embrace it because we're so busy and we can't imagine trying to invest the time it'll take. To kind of transition to that and rework our processes and sometimes sites get so many pieces of technology with studies that they support that that they don't really know where to start. They need some extra support and they don't know where to go with to get that support. So we do have, robust support system, we have a help desk and they can take emails or phone calls. And if something more is needed than what they can do they can get the person in contact with our project managers who can spend more time and help support on a deeper level and I'm available. So, if somebody just needs to talk through how to make this work in their office, they can certainly reach out through that system ask to speak to me, or even the project manager can get them to me. And we can definitely support the sites through this transition.

Vinita Navadgi: 15:59

Yeah, I just wanted to add one more point since, I'm a proponent of the product. Is basically again in the technology, we're trying to make it as simple and as intuitive to use as possible. Also there's a lot of guides and tool tips embedded throughout the product to make that experience much more simpler. And the requirement to call a help desk or to call somebody or even to call Dawn's, may not be required, but of course, those kind of options are always available if the need arises.

Dawn Strelow: 16:32

Yeah, I think you're right, Vinita, you make a good point. And I guess what I'm thinking is sometimes we make this bigger in our minds than when we actually dig into it. Right? So it seems kind of overwhelming, but when we get into it and see what's going on and what's there, it's much easier than we anticipated and you're absolutely right all the resources are in the system to support them, but, but there's additional resources available. Should they, should they need them? Okay. So as we discussed earlier, eConsent is much more than eSignature. So, eSignature is just, an eSignature platform may or may not have electronic consent, so to speak, but it could just be a PDF file that you put an electronic signature on. So, one of the things that we get confused is that difference and people assume they're one and the same. Sometimes when we're, we're talking about whether eConsent is allowed in different regions. With our system, and the way it works in an interactive manner, eSignature may not be allowed, but the use of the eConsent platform may be allowed. So what happens in those instances is that the patient gets entered in the system the same way as if they were going to do eSignature, they go through all the consent, the videos, the multimedia, they have the benefits of all of that and that deeper level of comprehension. And then when they finish, they can, instead of signing, they can mark a box stating that they plan to sign. And the consent is printed from the system. The dates automatically entered when the wet ink signatures are done on paper then, the site staff go back into the system and enter the date and time that the patient signed and then they can either file the paper copy the way they would if the patient went through a standard consent, or they can upload it into Complete Consent for digital storage. So very few IRB's or ethics committees are opposed to the eConsent when they understand that it can be done without using eSignature in those parts of the world that that don't feel comfortable with that piece yet, or don't have their regulations in place. EConsent text is an exact duplicate of the paper consent. It has some additional information like the glossary terms that can be submitted to the ethics committees and IRB, but the text of the actual consent is exactly the same. That being said, if a site is having issues or has concerns that their IRB or ethics committee, might not approve it, or they've denied it and they want to pursue getting it approved. We certainly can support that. We've got information that we share and and can help the sites go through that process and get that approved in their organization. One more piece to know there is that we also Complete Consent also offers an offline consent feature. So one of the questions that we get asked is, well, what if the WiFI's down? What if the patient doesn't want to sign on the tablet? What can we do with that? And so we have this offline feature where if the interactive consent can't be used for some reason, the patient can still be created in the system. And marked as completing an offline consent. This help sites so they can see all of their consented patients in one system. You can avoid having, like, a separate consent log that's more prone to error and that consent can be uploaded into the system just like the print to sign version. It can be uploaded into the system with that patient record. So everything still sits within the Complete Consent system, regardless of the signature modality.

Jimmy Bechtel: 20:45

Thanks Dawn. I think those were important explanations of some of the challenges that a lot of sites face and how we address those. It's great to hear that. It sounds like IQVIA technologies is listening to the sites because when we talk to them and ask them about the challenges that they face with technology, that support aspect is always one that rises to the top as being one of the major challenges that they have with the technology when things don't work. They, and the patients, should be able to seek support and get the support that they need in a simple and efficient manner. So it's great to hear that IQVIA has highlighted that and has dedicated resources to making sure that that portion of implementing these technologies is on par with their expectations. And again, I appreciate your explanation, of course, with the eSignatures because that's a, an important aspect, but a major consideration as you iterated. When it comes to how we make sure these technologies are successfully implemented at the site level. As we begin to wrap our conversation up here, I do want to ask you one more question, Dawn, what steps should sites take to encourage the successful adoption of these eConsent technologies, not only among their own staff, but also among the participants that they're bringing into these trials.

Dawn Strelow: 22:00

Yeah, that's a great question Jimmy. Clinical research sites should have someone to lead the effort with eConsent. That could be someone in a leadership position or someone that just has an interest and wants to champion the cause and then bring along the rest of the team to get on board. There's there's this temptation to continue with paper, like I said, because what it's what's always been done and it's familiar. So we need to be willing to step out of that box and make the change. Planning is the key to success with eConsent, just as it is with so many things. So, to realize the full benefit of using eConsent for the site for the patient process flows need to be adjusted. One example of that is to send the patient a link to the consent in advance of their appointment. Now, it's not a version that can be signed, but this is different than remote consent, which is a capability of our system but that's not what we're talking about. We're talking about something called the read from home version. So, they get a link to the consent and they can read through it at home. They can share it with family and friends. They can come in and having thought about it and being ready to ask questions and reducing some of that overwhelm that patients experience when they're first considering being enrolled in a study or first, signing the document to be enrolled. There's so many places they have to go within the facility, things that they've got to get done. It's just it can be really overwhelming. So this is one thing that we can make easier for them when they first, come in for the study. Perhaps the, site staff aren't comfortable with that. Maybe they don't want the patient to have it at home for some reason and they want to be able to talk to them about it right away. The patient could still get the tablet in the waiting room and be able to sit in the waiting room and make use of that time going through starting to go through the consent. Complete Consent is very intuitive and easy to use, but the unknown can be an obstacle to overcome with the patients. Sometimes. When we say, well, do you want to sign on the iPad? Do you want to sign on paper? They don't really know the difference. They don't know the benefits of one over the other. And in their mind, they're thinking technology complex. Paper easy, right? Our system is used successfully with patients that don't even have technology. They don't have a smartphone. They, aren't adept at using technology. So, it's very easy to use if we just help them to become familiar, show it to them. If they, for some reason, aren't comfortable, then the paper is an option, but 95 percent of the time, at least, if you show somebody how to use it and how simple it is. They're going to just move forward, we get handed tablets and places to read and sign electronically all the time. Even when we check in at the front desk of a doctor's office. So this is really not any more complex than that. And it's really very easy to use if we just help explain it to patients and help them to understand the simplicity. We also set up a practice environment for the staff to work with before their site goes live with their actual approved consents where they can go in and get a feel for it. There's a video when they first log in that explains to them some basics And as mentioned earlier, we've got tool tips in there where they can hover over different areas. That'll explain what that area does, but it's really very intuitive and easy to use for the site staff as well. Okay, that was that was a lot of information. So just to summarize that, to be successful, you want to have a champion and definitely understand and align with the team on the goals of why we would want to work with eConsent. Plan for the adjustments in the workflow as you work with patients from the time, they get that appointment scheduled until we actually see them and get them consented. And then get to know the system before that first patient in. So it's not a good time to log into the system and try and figure it out right when you've got your first patient because we don't want to leave people waiting. We don't want to delay anything. So so doing that first. And then maybe debriefing after your first patient or 2 with with the others involved and just see what went well and what could have been done differently. We also have this beautiful share feedback button at the top of the site page where you can send in your ideas. So, if somebody wants to say, well I really like how this works. Um, You know, they can send that or I have this idea of how it could be better. They can share that. But if they also want to say this buttons a little wonky, they can do that and provide that feedback. We really want to hear from our sites and understand what their needs are so that we can make the system work really well for them.

Jimmy Bechtel: 27:38

Well, thanks Dawn. I think that's an awesome place for us to end our conversation today. I appreciate you sharing some of the adoption insights for the sites that are looking for eConsent and what it means for them. I think this was a really great conversation covered a gamut of different aspects and considerations that our audience should consider again, when employing possible eConsent at their site. So thank you both for being with us today and sharing your valuable knowledge and providing a deeper dive into what eConsent means at the site level and what it means to employ this for our patients.

Dawn Strelow: 28:15

Absolutely very glad to be here.

Vinita Navadgi: 28:17

Yes, thank you very much.

Jimmy Bechtel: 28:19

For all the listeners, make sure that you register for upcoming summits being held throughout the year by visiting the summit page on our website myscrs.org. While you're on our website. Be sure to also check out other SCRS publications and resources built for the community in the publication section of that same website. We appreciate your participation in listening to today's program and look forward to having you join us for more great content coming out soon. For more information on what IQVIA Technologies is doing, check the description for ways to contact the team that we interviewed today. Thank you.