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Using eCOA to Overcome Data Collection Challenges in Oncology Trials

June 25, 2015

Recorded live 24 June 2015

We cover background information on eCOA, the importance of the patient perspective, some challenges that typically arise in Oncology studies, and how eCOA can help. Our guest presenters are Paul O'Donohoe and Jessica Thilaganathan.

Full Transcript

[00:00] 

MODERATOR

Okay so today’s webinar is called Using eCOA to Overcome Data Collection Challenges in Oncology Trials. And introducing Paul and Jessica, who will be your presenters for today.

Paul, I’m going to hand it over to you.

 PAUL O’DONOHOE

Thank you kindly, Naor. Good morning, good afternoon, ladies and gents, and thank you so much for joining us for this webinar. Greetings from a relatively warm London. I hope it’s nice in your part of the world as well.

As Naor said, we’re going to be discussing and sharing some of the learnings and experiences we have developed in CRF Health in regards to the challenges—quite significant challenges, sometimes—that we find in oncology studies, and some potential solutions for overcoming those challenges and capturing data directly from the patient and giving oncology patients a better voice in oncology clinical trials.

Just to give you a brief introduction to who’ll be talking to you today. Obviously myself, Paul O’Donohoe, I’m Director of Health Outcomes for CRF Health, based here in our London office. And I’m responsible for providing and coordinating scientific support both internally for my colleagues, but then also for our clients.

And I’m also joined by my colleague Jessica Thilaganathan, who is the Therapeutic Areas Coordinator. And she’s responsible for consolidating and coordinating CRF’s therapeutic areas expertise, including obviously oncology, and we’ll be hearing from Jessica a little bit later.

So what are we going to talk about today? Just a brief outline of the agenda. Just to set the scene, make sure everyone is on the same page, I’ll very briefly touch on exactly what we mean by COA and eCOA, just in case you’re not familiar with the terms. Then we’ll also dig into why the patient perspective is so important, this whole concept of patient centricity, I’m sure if you spend any time at conferences or at these kind of webinars and such, you’ve come across it on numerous occasions. But we’ll talk about why it might be considered so important specifically for oncology studies. And Jessica will take over and she’ll outline why in particular oncology studies seem to be so challenging from the clinical outcome assessments point of view, why is it that we’re struggling to capture good quality patient-focused data from oncology studies, when in other therapeutic areas we maybe don’t see them as been quite as challenging. And then she’ll also share with us some of the barriers that eCOA can then overcome, some of the improvements that eCOA brings to oncology studies over the traditional paper-based approach.

But just to get us started, we’re going to start nice and interactive. We just wanted to get a sense of the number of people on the line who have maybe used eCOA, electronic clinical outcome assessments, previously, specifically in an oncology trial. So you have a poll on your screen. If you could just quickly click for us and then submit.

Okay, we have results coming in, I’ll just give that another second. Interesting. Okay, so, lovely. So the minority have actually used eCOA in oncology studies, which was largely as we expected, with the vast majority saying no, or not yet but interested in doing so. So this part very much meets our expectations, that really eCOA is an under-represented area in oncology specifically. Okay, well that’s somewhat good because it really supports our argument for the rest of the webinar.

So just to, as I say, really set the scene, ensure everyone is on the same page, clinical outcome assessments are assessments that tend to get an understanding of the patient experience. So there’s three different kinds as per the FDA’s thinking. There’s patient-reported outcomes, which are basically information that’s coming directly from the patient with no interpretation being made by anyone, the direct patient voice, the patient telling you how they’re feeling and how they’re functioning. Are they in pain, are they depressed, are they able to go about their day-to-day work, directly from the patient. And this is really the kind of gold standard of how you get the patient voice in the trial, through patient-reported outcomes. We also have ClinROs, which is information about the patient coming from someone who has training in the specific area of interest, so in this particular case it would be information coming from an oncologist about how the patient is feeling and functioning. And we also have ObsROs, which are observer-reported outcomes. And these are information about the patient coming from people who don’t have specific training relevant to the measurement being made. So we’re thinking caregivers, maybe partners of the patient, who again can give you interesting insight into how the patient is feeling and how the patient is functioning.

[05:30]

When we talk about eCOA, these are basically just electronic clinical outcome assessments, traditionally COAs were developed on paper, it being the most ubiquitous technology. We’re now moving to a world where it’s more mainstream to develop and deploy clinical outcome assessments in electronic modes. And there’s a wide range. It goes from a desktop computer or a laptop to a tablet computer to a handheld device like a smartphone, digital pen, IVRS. There’s a range of different electronic solutions, but the main ones we’ll be talking about today, the ones that we see most commonly used in oncology studies, will be the tablet computer and the smartphone. And traditionally we’ve seen the tablet computer being used as a site-based way of capturing data, so for ClinROs or for patient-reported outcomes to be completed during site visits. And we’ve traditionally seen the smartphone, the handheld solution, being used for patients to take home with them and provide you, for example, more regular diary data, etc. So that’s just to set the scene on exactly what we’re talking about here.

To go into a bit more detail about the patient perspective and why it’s so important, specifically in relation to oncology studies. I think there’s a growing recognition—there was an interesting paper earlier this year that really kind of formalized this viewpoint that all stakeholders, including the regulators, recognize that there is a lack of the patient voice in oncology studies and that we really need to work to emphasize that voice somehow. Primary endpoints, key endpoints in oncology studies tend to be driven by survival data, biomarkers, imaging and whatnot, and PRO data tends to be under-representative. Now we are seeing some evidence that PRO inclusion in oncology studies is increasing, but there is still some challenges to their inclusion in studies, which Jessica will go into in a bit more detail. And I think all stakeholders really recognize that the patents are really the experts in how their disease is affecting them and how their treatment is affecting them. And I think in oncology in particular, where very often there’s very toxic treatments, and they can have very significant side effects. It really is important to get this understanding beyond the basic survival data, beyond the basic imaging data, of the real effect that this disease and the treatment is actually having on the day-to-day existence of the patient. Another reason why patient voice is so important is that one of the significant challenges faced by oncology studies is around enrolment. And it's one of the key failures for oncology trials, is not being able to enrol enough patients in the study, and I think this really emphasizes the fact that maybe we don’t have a full understanding of the patient perspective, when you’re truly hearing the patient’s voice from the really early stages of designing your protocol and even beforehand when you’re just exploring your novel treatments, to try and get an understanding of what those treatments do, I think hearing the patient’s voice from that stage, understanding what’s important to them and what they want to see coming out of clinical trials. I mean, the patients are more engaged throughout the lifespan of the study, and hence you're not going to hopefully run into as many enrolment issues as maybe traditionally we are seeing. And overall we’ll increase the participation and increase the efficacy of the trial you’re running.

But there are some other challenges faced, specifically relating to capturing clinical outcome assessment data in oncology studies, which Jessica is going to go in a bit more detail.

But first of all we just want to run another quick poll to really get your sense of maybe why there are these challenges with clinical outcome assessments in general. Now we’re not just talking about electronic, we’re talking about in general, why might we be faced with this situation, as summarized by that paper I referenced from earlier this year, where the patient voice is not really being represented properly in clinical trials. So is it because the patients are too sick? Is it because sites tend to be a bit too hectic? Is it because the questionnaires are too lengthy or too complicated? Or is it because the protocols themselves, what we’re asking sites and patients to do, are too complex? Or is it in fact something completely different? Unfortunately we don’t have a free text entry, so we won’t be able to get you to specify that, but it will be interesting nonetheless if a lot of people choose other. I’m just going to leave this run, please feel free to click any of those answers on the screen you think are most appropriate.

[10:30]

Give that another couple of seconds. Okay, so let’s take a look at the results we got in. It’s looking like we’re focusing on the length of the questionnaires, which is interesting. So when we’re thinking maybe of some of the questionnaires that come out of the FASTA group, some of the questionnaires that come out of the EORTC group, they are initially quite lengthy, the basic QLQ-C30 is obviously 30 questions and they tend to add modules to that. So obviously a lot of people feel that that’s a challenge for participants. We are seeing quite a few Others in there. So maybe people can add into the comments some of the additional reasons why they think clinical outcome assessments are so challenging, and we might be able to discuss those once we get to the Q&A session later on in the presentation. Patients are too sick, and sites are too hectic, protocols are too complex, are all pretty much at equal amounts as well. So that’s interesting results, I wasn’t expecting the fact that the questionnaire is too lengthy to be the overall winner in that particular poll. But if you have any thoughts of anything else, that really is affecting how successful COAs are in oncology studies, please do add them into the comments and we might try and get to some of them once we get to the Q&A session at the end of the presentation. Thank you kindly for taking part in those polls.

I’m now going to had over to my colleague, Jessica, who is going to run you through some of the challenges with capturing clinical outcome assessments, and how eCOA can help address them.

JESSICA THILAGANATHAN

Thank you, Paul. And good morning or good afternoon, everyone on the phone. Thanks for joining. As Paul said, I’m going to talk to you about some of the challenges that we’ve perceived to be kind of the biggest problems in oncology trials, and how eCOA can help solve them.

To start, what are the real challenges that eCOA can help to solve in oncology studies? Well, Paul has already touched on the fact that recruitment is a massive roadblock in oncology studies. Another issue that is a major factor is their complexity. So oncology studies can involve complex and toxic therapies, and that can result in a really high incidence of both treatment and disease-related adverse events as well as co-morbidities. And that can really add to the number of challenges in solved in a study.

So some of the main challenges—and they were touched upon in the poll that you all just completed—that we’re going to address in this seminar, include the complex protocols and the increased burden on patients that that brings. So as we saw with the results of the poll, lengthy questionnaires were the thing that was perceived to be one of the biggest barriers. And in addition to the length of the questionnaires and including more of them, that really does add to the burden on patients. And patient retention, so how do we keep patients in the study, particularly if they’re not seeing a positive effect of their medication or their symptoms are worsening, how can we stop them from dropping out if they can still continue. And how do we track key endpoints—so how do we track pain, and how do we track how patients are relieving that pain—as well as poor patient recruitment and engagement. We’ve seen that really difficult to get patients into oncology studies and keep them engaged, so how can we address that. So we’ll talk about these problems in a bit more detail and then talk through some of the potential solutions that could be offered.

So I’ll start with complex protocols. They can make the site visits burdensome, not just for the patients but for the site staff involved. As we’ve mentioned, recent papers have shown that the number of PROs in oncology studies is increasing, but with this increase comes an increased time needed for the completion of those questionnaires by the patient at their site visits. And this can really make the visit schedule quite busy, and can all lead to confusion, particularly with the complex protocols and the visit cycles, they don’t always have to complete the same questionnaire at each visit—that might change—so that could lead to some errors if site stuff put the wrong questionnaires in at the wrong visit. And simply there can just be too many questionnaires to be completed in one site visit. It just might not match up with the allotted time, and that means that errors are made and data is missing.

[15:00]

So what about patient retention. It can be really difficult for patients to comply with a study if they’ve become really sick and they can’t attend visits anymore. We know that in many countries sites are in quite remote locations, particularly for oncology, and so that involves a great deal of travel and organization for a patient. And if they become very sick, they might not be able to fill out one of the questionnaires without assistance from a caregiver. So that might be an issue if they can’t have a caregiver with them at their site visit. And they can obviously be experiencing a great deal of pain. And this is something that can be really difficult to track, particularly also tracking what medication they are using to relieve their pain. And pain is often at the endpoint in our oncology trials, so how can we better get that data.

And recruitment. So recently Paul and I attended a conference where someone presented that over 40% of oncology trials are failing at the first hurdle because they can’t achieve the minimum patient enrolment. That’s a massive issue. They can’t get people into their study to begin with. So that’s only going to be amplified with the promise of personalized medicine that’s coming along. Because the need for a smaller, more specific patient population means that we have to screen even more patients to find the ones that are eligible for the trials. So that’s very difficult if we don’t have patients coming in to screen in the first place.

So we talked to you about some solutions to those challenges I just discussed. So even though we can help solve these problems in a few different ways, the first solution I’m going to talk to you about is an electronic concomitant solution that will track patients’ medication use. So as I mentioned there’s a key endpoint for pain, and we want to be able to track how patients are relieving and monitoring their pain. How a user-friendly eDiary can reduce the burden on sick patients, and how that can maybe help keep patients in the trial, as long as they want to and can physically be present in. And electric tools that will help  the sites to stay protocol compliant. How can we reduce their workflow and their hectic-ness to help them with an easier way to navigate through the complex protocols and all the different questionnaires.

So first up, the concomitant pain medication solution. So why is it really essential to capture ConMeds? Well simply to test the efficacy of the drug. We have to make sure that the relief in symptoms associated with the study drug can be differentiated from the symptoms that are relieved by any additional medication the patient might be taking. So recently the FDA has suggested to some sponsors that analgesic use and pain should be captured using an eDiary. So obviously linking capturing and monitoring a patient’s pain and the medication they were relieving into an eDiary seemed like a good step.

And at the moment there are quite a lot of difficulties with capturing medications. Patients have access to potentially thousands of different medications. And the list is only constantly changing and growing and updating. And so that can be really hard to keep track of. Not only that, but medications shave different names in different countries. What might be paracetamol to us in the UK would be Advil to those of you in the US. And patients may often use an unknown therapy that the sponsor did not think of in advance. So the sponsor might come up with a list of all the ConMeds they think patients might take during their study. But they might not have every drug possible or every mode of a drug on that list. And so if it’s not on that list, then the patient might have to wait until the next site visit to say, I’m using this drug and start reporting it, so there’s a time delay in reporting the additional medication use. In addition, giving the patients free entry to write in medication they might be taking can really lead to messy data that can be duplicate, spelling mistakes, or inconsistencies of names, and then that would require deciphering further down the line to clean that data, which is very timely and costly and something we want to avoid in the study.

So how can an electronic diary help patients report this medication and get rid of some of those problems? Well the diary could include a pre-defined personalized list of medications that the patients can choose from, so they don’t have to scroll through the entire list a sponsor might have provided for that study. They also have the ability to give a medication a nickname as well as a trade name. So they can give medication, for example, “morning pink pill,” so that when they pick up that pill to take it, it’s easy to report because it’s just what it looks like, so they don’t have to think about, oh what is it, what’s the actual name of this drug, it’s just morning pink pill. As well as the trade name, something like Advil, rather than what the scientific name is, so that would avoid any confusion for the patient about what drug did I take when? We can also enable patients to search for the medication in their list. So rather than scrolling through a whole list, they can enter a few characters and search for the word they’re looking for. And that means if they don’t know exactly how to spell it, they can just enter a few characters and get a list of words and pick the right medication from that list. We can also guide a patient through adding new medication to their list if it’s not already in there. And that’s really important because then they don’t have to wait for the next site visit and take their box of drugs with them and say, I’ve been taking this, this, and this since I last saw you. Instead they can add in an easy and intuitive way the medication themselves and start reporting it straightaway. And then, when it’s input, we can allow the patients to see what they have reported and when. We can help them to track and monitor their condition and see how they are relieving their pain and what they are taking, so they can monitor it more effectively.

[20:45]

So to really complement this, we need to help the investigator and site staff keep track of what it is the patient is saying they are taking. So this should be done by electronic portal. So this will enable the investigator to receive notifications of new medications that the patient has added to their diary. And then this gives them some choices. They can review the information, see if there’s anything missing that they might need to add extra details for. They can add new medications that they think might be related, that the patient might start taking if they’ve taken this medication they’ve just added. And they can also address any incorrect data, so if the patient has made some spelling mistakes or gotten the wrong dosage, the investigator can look at that and also remove any duplicate entries that there might be metadata in the database. If the patient has added medication that’s already on the list but they just couldn’t find it, then that can be removed and sent back to the patient.

So all these changes can then be synchronized back to the patient’s eDiary, so the next time they’re reporting their medication, all of their errors have already been fixed and they can continue to report effectively.

So on the next slide, I’ve got a few images of what a ConMed solution could look like. There’s a couple of different features shown. Here on the lefthand picture we have an image of what the subject’s personalized medication list will look like. As you can see, the medication is listed with the name, the dose, and the route. And there’s also the function to either edit this list or add a new medication if the patient thinks something is missing that they would like to report. And as we mentioned, rather than scrolling through the whole study list provided by the sponsor, they can tap in a few characters using the keyboard and search for the medication they’re looking for, and then in that list they’ll get all names of all the medication with their characters, and then they can click on the one they want and click Next and go through the process of adding their own personal list. So it’s nice and easy and intuitive and helps to guide them through without too much extra burden.

Here is an example of what the electronic portal could look like. So here on the top left we have the patient has added the new medication to their personalized list. And this has to be reviewed by the investigator. So the details of the medication that the investigator needs to review are shown here, and they have the choices to accept, edit, or remove. So in this case, the patient was unsure about the strength of their medication. So this is something that the investigator would need to follow up on. Either they might know what strength it is and add it in themselves, or they should follow up with the patient at the next site visit or on the phone, and say oh what strength does it have, this medication you’re taking, and add it in. And then they can confirm it and it can be synched back to the patient’s diary. There’s also a nice summary of all the medications that have been added to the patient’s diary, so it lists all medications that they may be reporting that they’re using to relieve their pain.

So how can we help the sites to stay protocol compliant? We know that there are quite a lot of site pushback towards PROs because they find it hard to keep track of all the PRO data that needs to be collected and in which order. As we mentioned, with the complexity of protocols, there are different cycles and different questionnaires to be required at different visits. And that can be quite complicated for site staff to keep on top of. So an electronic visit scheduling tool can really help to keep the sites stay compliant with the protocol, as the system can present the right questionnaires in the correct order for that visit. So instead of thinking, oh I’m on Visit 1 for this patient and I’m on Visit 2 for this patient, which questionnaires need to be done, they can just go on that patient on the tablet and activate the visit that they’re on, and then they’ll see which questionnaires need to be done in which order. Notifications can also be sent to the patient’s eDiary, or a text message sent to their phone, to inform them of an upcoming site visit. So that can help with compliance. Site visits aren’t always very frequent, so a patient might forget next week on Tuesday I’ve got a site visit. So this will just help to remind them that they’ve got a site visit and they should bring their diary with them. Helps them to stay compliant.

[25:02]

So here’s an example of what a site visit scheduling tool could look like. As you can see, in this case, they’ve called the visits courses, and there’s Courses 1 to 5. And this is the status of the visit. So Course 1 has already been completed, and the patient successfully completed all of their questionnaires, that’s why it says, “all forms completed.” Course 2 has been activated, so that means that the patient’s coming into their Visit 2. And once it’s activated, they can complete the EQ-5D-3L and the EORTC  QLQ-C30. And then when they’re done, all the forms will be shown as completes. So that avoids any confusion because you’re just activating the visit that they’re on and just seeing the questionnaires that they need for that visit.

Another way to help with protocol compliance is with key endpoints. So secondary endpoints commonly measure the effects of treatment in improving related pain or pain palliation. And patients’ pain as we know is often one of the first things that is measured during a site visit. A patient will come in and they’ll say, oh rate your pain on a scale of 0 to 10, when they’re at their visit. But in between these visits, that kind of measuring of pain is often lost completely. So that’s really something that eCOA can help with. So a patient on their eDiary can rate their pain every day on the same 0-10 scale. And then if their pain is significantly worsening over a period of time, or really spiking, that can be flagged back to the investigators through the study portal, where there can be flags of the patient’s worsening pain, or the investigator can also see a graphical format of how that patient’s pain is changing over time. So if something is going significantly worse, it can help with that remote management in between site visits.

So I’m now going to hand it back over to Paul, who is going to talk to you about how to manage patients who become very sick.

PAUL O’DONOHOE

Thank you kindly, Jessica.

I think that this is one of the key pieces and key challenges in oncology studies is the fact that we are often dealing with a very unwell patient population. And I think we all recognize that but in the rush to try and get a clinical trial set up I think we can sometimes potentially lose sight of the importance and implication of that issue. One of the key concerns we hear raised again and again about using eCOA in oncology patient populations is concerns that the patients will be too sick to use the system. In fact this isn’t something we see borne out at all in the oncology studies we run, and I think a very simple way of conceptualizing the issue is really would you prefer to use paper and pencil to report your symptoms rather than a touchscreen device if you weren’t feeling very well. And I think we would all intuitively lean towards the touchscreen device, the low-burden solution of using a touchscreen device. So certainly having patients too sick to use the system is not a challenge we’ve encountered before. However, we are dealing with very sick patients and there are different challenges inherent within that. One of the ones we hear from sites is that sometimes patients become too sick during the site visit to actually complete the visit. And if that happens, there will be a need to reschedule the visit or extend the data entry window for that particular visit. And one of the benefits of the system that Jessica demonstrated for managing the protocols on sites is that this can be easily integrated into the protocol management system to allow sites to reactivate visits that were maybe incomplete or interrupted at a later date, or to add unscheduled visits for the patient. So they can actually add a visit for the patient directly into the electronic system. And all of this can be monitored through integration with IVR to really give the monitors a sense of which visit and which questionnaires have been completed for a specific patient or at a specific site.

[29:19]

However, we are sometimes faced with a situation where in fact the patients become so sick that they actually can’t even make it into the site at all. So if you have a situation where they can’t reschedule a visit—so maybe they’ve got to the state where they simply aren’t going to be able to come in for site visits—you might need to capture data from the patients in some other way. So one possibility would be administering questionnaires over the telephone. And there are some validated questionnaires out there that have a specific phone script, which allows site staff for example to ask the questions for a specific questionnaire of the patient in such a way as not to bias any of the data that’s being captured. But this does not tend to be the norm, to be honest, we don’t tend to see phone scripts for validated questionnaires. One solution we did see with a certain amount of success previously was sending home laminated copies of the questionnaires with the patient, or hard copies of the questionnaire, and then they would simply dictate their responses down the phone to site staff at the data collection period. So they would be able to read the questionnaire in front of them, off a laminated copy, but then they wouldn’t have to fill in any forms, they wouldn’t have to ship any of those forms back to the site. So that is one possible solution. But technology really gives us the chance to use a more interactive, a more low-burden solution, which is the possibility of mixing data capture modes, specifically mixing electronic data capture modes.

So if we’re aware that for our specific clinical trial that the patient might become at some stage too sick to come in for site visits, we can actually plan proactively for this and we can develop a two-mode-of-administration approach where we, for example, would administer questionnaires at the site visits for the period of time that the participant is well enough to come into the site, but we would also have the same questionnaires on a handheld solution, which at the point where they no longer felt they were able to travel in for the visits, the patient could then complete those questionnaires at home, so the exact same questionnaires, but they are just administered on a different platform. So it allows the participant to participate for much longer than they might otherwise, if we were demanding that they come in and provide data in actual site visits.

This does raise some regulatory questions around mixed modes of data capture. And there’s potentially some requirements for demonstrating equivalence between those modes, particularly when you’re capturing the same questionnaires on different devices. But this is work that’s been done on a number of different questionnaires before so I personally feel there’s no real risk involved in this but it might be something that needs to be considered from a regulatory point of view to provide this data. However we feel this approach really brings great benefit to all stakeholders involved. It’s a smaller lighter device, the handheld device, similar to commonly used smartphones. So it’s much easier for the patient to interact with than, as I said, with paper and pencil, but it also may be easier for them to use the tablet that they might be using on the site. From the sponsor point of view, generally, handheld devices tend to be less expensive than the tablet devices used in site visits. It also—really I think the key thing—means you’re minimizing the amount of missing data, and missing data is the bane of any clinical trial. So anything you can do to limit the missing data, and continue to capture that patient’s voice, is hugely valuable. So it provides you more complete data sets even when the patient can’t travel. And obviously the key thing is it’s a far more efficient approach than using paper backups, which require obviously the participant to interact with the paper, but then to get it back to the site for that data to be entered and it comes with all the challenges that we see with paper in regards to missing data and low quality data in general.

So thinking even beyond this, unfortunately we are sometimes faced with a situation where patients are not able to provide any data, or they’re just not comfortable providing any data, interacting with any of the devices or paper. But we might still want to be getting a good sense of the patient experience within the study and the patient experience on the treatment. And then we have the option of broadening the people we are capturing those data from. We can build in the option to add a caregiver role, so that once the patient reaches the point where they say I’m not comfortable providing data anymore, the caregiver role can be initiated, which means the caregiver completes caregiver-appropriate questions, and again providing you with this more detailed insight into the patient experience and a more complete data set.

[34:35]

So I think the real takeaway message is that these electronic solutions are really very patient-focused and are really designed for enhancing the patient voice. They’re designed to fit into the patient’s life. We build these from the ground up as a patient-centric solution. Our end users are really the patients. So we build them to be intuitive and user-friendly from the patient point of view. But it’s also a very powerful technology they’re holding in their hand, so it gives them the possibility of maybe tracking their condition, but it also allows a certain level of communication between the sites and the patients. And we’ve often heard from patients that this reassurance—any symptom data they’re reporting, any ConMed data that, as Jessica was showing, they might be reporting—is being observed, is being reviewed, so that if there is any concerns or issues, the site will be in contact. Patients say they found that very empowering and reassuring. And I think it’s also important to highlight the benefit of engagement with patient advocates. We’ve done some work with oncology patient advocates before, but I think there’s huge scope for more input from patient advocates. Again, as I said at the very start of this presentation, from the really early phases when you’re just working on your novel treatment and just designing your protocols, getting the patient voice, not just during the study but when you’re actually designing the study, I think is key to bear in mind.

So to sum us up and bring us to the Q&A, I’m going to hand back to Jessica.

JESSICA THILAGANATHAN

So I think we can conclude that oncology studies are really complex, and it can provide a number of different challenges for all the different key stakeholders. There are challenges for the sponsors, obviously there are challenges for the sites with the complicated protocols, all the questionnaires, and for the patients managing their condition, their pain levels, and having to report all the data. But I think it’s clear with this patient-centric approach that eCOA can really improve data quality with tools that help eliminate and reduce that burden, that help to improve the site workflow, make things more logical and intuitive, and reduce any more manual errors to make them more protocol compliant, and to improve the patient retention. E-COA can really allow a variety of flexible strategies that can really be helpful when patients become really sick and help to capture those key endpoints like pain levels. So I think, overall, the key is to make things as patient-centric and as low burden as possible, and to really help the site staff as much as possible with those complex protocols and all those protocol amendments to keep things as streamlined and efficient as possible with the time that they have.

So I think we have one more poll before the Q&A session.

MODERATOR

Yeah, I always find that in webinars like these where you’re often on mute, the best way for us to know if you’d like to learn more about eCOA for oncology is to flat-out ask it. So I’ll leave this up for a moment. If you’d like for Jessica or Paul to reconnect, or put you in touch with someone on our end to talk a little bit more about it, we’re happy to do so. You just let us know. And while we discuss that, we do open up the chat for any questions that you might have. I’ll flip the screen in just a moment, but please feel free to type in your questions for Jessica and Paul at this time.

[Q&A section starts at 38:28]

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