ePRO - electronic Patient Reported Outcome

hello and they come at the GCP mindset channel I hope you are doing well today we speak about a very modern and I think also interesting topic it's about electronic patient reported outcome or short ypres and I have my expert Sebastian Russell here with me and yeah thank you for being here yeah hello thank you Andres for the warm welcome and I'm really looking forward to answer all your questions about the electronic data capture and especially what the EEPROM thanks B to C bus down thank you very much for being here to speak with me about electronic data capture I know you as an expert for clinical research you are especially in exploit an EDC systems and also a pro and I know that you also developed your own April system together with your team maybe you can tell me a little bit more about yourself yes thank you Andreas I'm now for good five years the clinical research I'm working in clinical research organization in clinical data management and as you already announced 12 is the electronic data capture and different systems and be April and main focus of my work is also to do a lot of consulting and work with the clients to get the best out of the systems possible thank you but when you're working for us here or what's the reason why have you developed your own ecosystem there are so many systems on the market already and what's the rationale behind it yes you have I mentioned there are quite a lot of ypres solutions on the market and we have observed quite a lot of them and we always recognized on the one hand there's often a huge amount of costs connected to ypres and many people complain about the complexity so these were rationals for us to develop an Oni Pro and especially target these two drawbacks of many commercially Pro solutions so we've decided on the one hand to go to a fully web-based application so that you do not need any special device or any specific hardware but can use whatever you use in the daily life to complete the April and in addition our system was aimed to be as easy as possible especially for the data manager who needs to do the setup work and for the side stuff who needs to manage the subjects in the system okay that makes sense in summary you wanted to Omega more cost-effectively and more simple for the users yes andreas you are right we have seen that most of the commercial solutions are quite expensive and more target onto the big pharma companies whereas our clients of are usually small to mid-sized companies who do not have so much money so this was one of the major goals to develop our own ypres to also offer them affordable solution and in addition developing in an own ypres also enables us to directly integrate this part of clinical data capture into our complete clinical trial management software solution that makes of course completely sense but let's ask another question how useful is it anyway to collect data from patients directly we know that the variation of patient reported outcome is quite large that means we need more patients to evaluate this data so why do we collect data from patients directly so you are a rightness of variation but I always also compare past and present paper reported outcome and electronic outcome and if you do that you can get much better compliance and much better answers if you directly collect the data electronically as you can narrow down the windows when answers can be provided and you can also prohibit false answers you don't need and by that the electronic patient data is there more reliable you get a higher compliance and by that you need less patients for your trial and again end up with lower costs but it's a really military to ask it is not mandatory but there are quite some factors which can be better asked directly to patients if you think of pain or anxiety events they can be more realistic assess directly by the patient's once the event occurs and not they need to recall it during the next study visit and anyways it's a trend you can see in clinical research and even the federal organizations like Food and Drug Administration in United States highly encouraged and for several kind of studies even expect that you also collect patient outcome sebastien you just mentioned already one example pain measurement but what kind of other parameters are measured by April so one prominent example is whenever you need patient satisfaction so standard in the industry is to ask for quality of life with predefined questions and how well the patients are and another quite prominent example is to use Ypres whenever you are interested in collecting specific events if you for example think of incontinence and want to collect whenever your participant has issues with an incontinence event or other studies where specific events should be collected then it's quite helpful to use an EEPROM and just one question to illustrate this do you remember just spontaneously what you had on Thursday for dinner sorry no I don't remember and now you see why it is so helpful to have an e per solution at hand to capture specific events directly upon occurrence okay yeah that makes sense but you mentioned already pain incontinence diaries I guess but what medical data can be captured with April so you already mentioned quite some examples met on a medical scale you can collect as mention pain for example we use visual analogue skates where participant rates for example from zero to ten how intense the pain was you can ask specific questions about satisfaction or quality of life you mentioned the Diaries or also free texts but we also seen increased needs to also incorporate additional data so think about for example more and more people using variables like smart watches that collect heart rates blood pressure and we get more and more requests to also get this data into an E Pro and connected to patient data personally I work the first time was April about 15 years ago and at that time we still use pilots for electronic patient reported outcome nowadays probably most of the people at least our Watchers I think they they don't know what is primary more but it was quite complicated and the data we are not of very good quality because most of the patients were completely overloaded with information was too complex for them and still nowadays I hear from sponsors is April also for older patients or is it only for young people what what's your thinking about that so I think April is for everyone so you already mentioned the past was designated devices for April that were hard to correctly use and enter all the data and there I would also agree that this was more for the younger people who are familiar also was some more exotic kind of devices and hardware nowadays the journey in April goes to web-based applications and people use the smartphones to answer and there I would say April is for every age groups and just recently I met a person who's already 100 years old and owns a smartphone and uses whatsapp to get in contact with his family so even those age group nowadays uses smartphones and wouldn't generally be able to answer some pretty Pro questions yeah that means actually people were no smartphone are exceptional that's not normal anymore it is exceptional as you mentioned so older people still sometimes do not have them but then they at least have their computer and use email and also have their means to answer a neat row no lovely I can even imagine that electronic data capture is even an advantage for some older people correct yes definitely if you think of a paper question yet and everything is fixed in size and if your participant cannot read the questions he cannot answer if you have an electronic solution it is easy to just increase the font size or the size of the display of all the questions and then it's much easier for people who cannot look that well to answer the questions and this is also what we have observed in several of Technology studies where the participants also answer the question as as baseline prior to getting their surgery so they already have vision problems but as they'll have very few problems and answering complex and long questionnaires okay I think the advantage with better data quality better data integrity smaller sample size are clear but what about the acceptance acceptance of the users so patients and study sites I can imagine that patients are quite happy but study sites need longer to explain the patients how the electronic questionnaires and Diaries work do they like it so you already mentioned quite some points let's start with the patient view they usually like it they are used with electronic devices nowadays and as the ePro goes to web-based and easy to use applications and do not complain much as they do not have much extra work often it's even easier for them to directly record electronically than on paper with the sides of course it's a bit different but there it is especially important that your solution is easy to use and easy to explain and as they need to explain a technical part to the sides it is very crucial and this is also what we observed that the sides are properly prepared for this extra task by training in advance okay but I think it's even just a matter of time that everybody except I mean for younger people it's more normal to document something electronically than on paper and both patients are getting younger and also study stuff or side stuff is getting younger I would definitely agree to that younger people do record everything electronically and do not use any paper notebooks or something like that anymore let's come to a technical question according to my knowledge there are two systems on the market one is more F based where people need to download a software on the device or gets the device and the other that's what you are using it's browser-based where you always need internet connection so my question would be what's the advantage of the first and the second system and if your system needs internet connection are there any problems nowadays so you correctly mentioned the two types of ypres applications currently on the market there are some that use native apps that of course have the advantage that we directly on the device of the participant and they can also answer why they are offline but then of course everything they answer is also stored on the device and can easily be excessive for example the participant loses his or her smartphone on the other hand you have the web-based applications that of course have the drawback that they need to be connected to the Internet but this gets led less and less a problem as the global coverage of Internet is increasing and increasing and in addition like all applications on the market also our solution has means to deal with connection issues so for example if the patient is currently answering a questionnaire and the connection got lost the system recognizes this and automatically stores everything that was answered prior to the connection loss so no data already entered can get lost and in addition you have the advantage all the participant answers are only stored on a secured server under our control or not on the local devices and cannot not so easily get lost or get accessed unauthorized yeah and what kind of internet connection is required do you need 4G or even 5/3 or how fast that doesn't need to be so the solution is aimed to deal with all kind of internet connections and so you just need to be connected to the Internet the speed is not so relevant of course it's an advantage to have a faster connection but also slower connections quite easy to answer a pro question is okay the best you mentioned now a lot of advantages and everything is logic and and clear but I can also imagine that there are limitations from what kind of studies would you not use April yes there are some limitations you always need to keep in mind what kind of study you are doing and what kind of study population we have in so for example if patient reported outcome is not collected during a study if you think for example about phase one studies were just leasing on the safety of a product it does not always make sense to us the patients as well in addition there are several patient groups which you would not like to bother with additional questionnaires on the one hand if you have a very old study population just not familiar with questionnaires and with the technical details if you have a very young study population and you can think about having the parents answer for their children and last but not least there are some patient groups where it just would be unethical you would not ask a patient who has only a few days left in his life for quality of life or something like that but if you keep this out then there are not many limitations anymore for the usage of ypres okay sure if we don't collect patient data directly we should not think about using Epona study just to use a pointer study that's clear and I can imagine for the future that caf or data collection why are CFS are getting is getting less important and I can imagine that if who is getting more important you mentioned already wearable it's like smartphones where you can measure directly in sleeping behavior heartrate physical activity and so on and by using that you can collect more and more data directly wire ePro and you don't need to collect so many data wire as a CF anymore which I can imagine and shows a better data quality you don't have so much work with source data verification anymore what do you think what's the future so first of all we can observe an increasing number of requests to include April into clinical studies so the overall trend is to collect more patient reported outcome in addition one trend will be as already mentioned the collection of additional data for example from variables like smartwatches imagine for example a study where the study population has heart issues and you collect a long time ECG and directly connected to it a patient activity diary and have all these data sources directly in one database this of course makes it much easier to compare line this data and for these kind of studies I would even say that these loses some of its importance so you already have the data in one place there so especially for observational studies or these kind of studies the ECF lose some of its importance I can't even imagine for data like communication I mean it's anyway the patient we brought to the investigator at least for chronic communication which medication the patient takes so why not asking the patient directly what's your daily medication and and we both know for these adverse events and medication there are also done a lot of mistakes by the investigational sites and so I think it would make sense to ask the patient directly definitely we already have projects where we are doing this and we are making good experience in that think for example about studies where the population suffers from allergies then often there is a very limited set of for example rescue medication that is taken in case of an event and then it's much easier and much more reliable if you directly ask the patient answer directly in April every time you need to take this rescue medication ok let's come to the end what would you recommend responder with no experiences occur yet and they want to select April system for the study what do they need to consider so first of all and most importantly they I would recommend that they focus on a system that is easy to use for everyone involved especially for the trial participants they need to answer our questionnaires or a diary and therefore they should have it as easy as possible and it should be as best as possible integrated into their daily life and of course it also needs to be easy for the sides we discussed the topic with the sides needing to explain it to the patients so also they should have it as easy as possible besides that April's of course always one cost factor for a study so I would recommend to also cause a solution that is cost effective but remains flexible and last but not least Soph course very important in the context of clinical trials that the applications use fully compliant with regulatory requirements mainly 21 CFR part 11 okay great thank you very much Sebastian thank you very much for the nice interview it was very interesting and I think people in general has a great future for sure yes many things Andreas it was really a pleasure meeting you today and answer your questions and talk about my expert topic thank you I also hope that you liked our video about a pro that was attractive for you and you should try it and future when you have not used it yet please send us your questions leave your comments and if you have another topic you want to discuss send us a message bye bye [Music]

Channel: GCP-Mindset - All About Clinical Research

Views: 807

Rating: 4.7142859 out of 5

Keywords: CRO, clinical trials, trials, interview, budget, clinical research organisation, cra, clinical research associate, klinischer Monitor, monitoring, research, pharma, pharmaceuticals, Pharmazeutika, klinische Forschung, pharma industry, Pharmaindustrie, klinische Forschungsorganisation, ethics committee, Ethikkommission, benannte stellen, nominated bodies, notified bodies, gcp-service, Andreas Grund, Forschung, ePRO, electronic Patient Reported Outcome

Id: 6CB6DoVFCNE

Length: 20min 59sec (1259 seconds)

Published: Thu Jan 02 2020