The Sentinel System – FDA's Post-Marketing Safety Surveillance System for Medical Products



good afternoon this is Bray Patrick Lake I'm the director of stakeholder engagement the Duke Clinical Research Institute and I'll be serving as moderator this afternoon for genetic alliances webinar on the Sentinel system FDA's post marketing safety surveillance system for medical products so today you're going to be hearing from two presenters our first is Tyler David Coyle he is a medical epidemiologist with the office of surveillance and epidemiology which resides in FDA's Center for Drug Evaluation and Research Tyler earned his MD from Columbia University College of Physicians and Surgeons he's been very dedicated to the field of Epidemiology FDA but we also have personal interest he enjoys craft beer cooking and he read science fiction after Tyler you'll be hearing from Steve Makita who is an FDA patient representative for the rare disease spinal muscular atrophy I'm Steve septation engagement representative for the Sentinel system and he's also a member of The Sentinel Planning Board the last three years Steve has led the engagement partners work group to raise awareness of the Sentinel system Steve lives in Salt Lake City and he is also an attorney so with that let's go ahead and turn it over to Tyler great thank you very much so again my name is Tyler Coyle I'm a medical epidemiologist at the FDA and it's my pleasure to speak with you today about the Sentinel system and it's a first off I just want to thank the organizers of this webinar for inviting me and Steve Nikita for leading the work group that has underpinned the framework leading to this webinar and also to all of you for joining us to learn a little bit more about the Sentinel system so you might be asking what it is sentinel well if you remember one thing about this presentation I hope you remember this slide sentinel is SBA's medical product safety surveillance system created in response to a congressional mandate Sentinel is composed primarily of electronic health care data and administrative claims data it's also based on a distributed data network and a common data model it will go over what all those things mean but first let's look a little history of the Sentinel initiative in 2007 Congress passed the Food and Drug Administration Amendments Act or budhah as we call it at FDA the DA told FDA to create an active surveillance system for monitoring medically regulated products nationwide so in response in 2008 FDA launched the Sentinel initiative in 2009 this initiative evolved into a full-fledged pilot and in 2011 this pilot grew and grew and grew to the point where it encompassed 100 million lives worth of data as mandated by the legislation that act that created it further in 2012 we continue to build the system so that a suite of reusable programming tools could be used to ask questions of this enormous dataset and finally in 2016 FDA launched the Sentinel system as a routine component of drug surveillance at the Food and Drug Administration Sentinel uses secondary data this means that the Sentinel system isn't going out and collecting primary data from patients instead is using data generated from patient interaction with the US healthcare system as you know the US healthcare system has some quirks and so Sentinel has been built to try to adapt and modify to these quirks so that we can get the best data available as you know data is collected for a lot of different reasons in health care one reason is for reimbursement payment and billing another equally if not more important reason is to document clinical care additional data is collected to support physician decisions and for other reasons as well such as record-keeping and registries so data data data data is the central component of sentinel at the sentinel system and it's what we focus and a lot of time on so I just to reiterate the previous slide data is collected for administrative purposes it also collects clinical data so when you go and visit your healthcare provider that data may be collected by fentanyl and registries are an important source of data particularly for specific populations of interest and particularly for less common diseases Sentinel captures billions of encounters with the healthcare system from 2000 to 2016 we have over 223 million unique patient IDs in our database with nearly 180 million of these patient IDs having both medical and pharmacy data associated with them currently there are over 40 million people accruing new data in the system and there are over 400 million person-years of observational time within the Sentinel system it's enormous so how is all this organized it seems really like there's a lot of disparate sources and a lot of different kinds of data so it seems like it would be hard to put it all together well you're absolutely right and so that's why Sentinel is based on a common data model a common data model is a language that different health system data sources can convert their information into that allows for aggregation of large amounts of data into discrete populations and samples so patient data stay secure because the source information stays at the health care system in the Sentinel distributed database so here's a schematic showing what I'm talking about here with a distributed database and with a common data model as you can see in the top right you see the Sentinel operation center or SOC now FDA works with the SOC to generate a question in the form of a computer program Sentinel Operations Center then sends this very specific computer program choose the data partners – that are distributed across the country and represent a variety of different entities and healthcare payers these healthcare payers and data partners have all converted their data into the common data model format that includes elements such as enrollment symma graphic information medical utilization so how many times they're visiting the emergency room or a patient is visiting the primary care provider pharmacy prescriptions diagnoses procedures lab tests and vital signs so all these data are held in this common data model format the computer program runs against that data generates results and then that data is fed back to the Sentinel Operations Center for review and creation of a report that's been reviewed and interpreted by FDA to guide regulatory decision-making and safe safe drug practices so the Sentinel Operations Center lead is the Harvard Pilgrim health care Institute there are other very important members of this system who contribute valuable expertise such as the data and scientific partners listed here and then further scientific partners who are collaborators on important and large-scale projects that help us better understand the safety of regulated medical drug products here's a listing of some of the data partners this is not an exhaustive list but as you can see we've got some big names in there that have enormous amounts of data and we really value our close relationship with our data partners because without them Sentinel cannot do what it's meant to do so why is Sentinel important well Sentinel generates real old evidence to support regulatory actions aimed at protecting the public health and this evidence help helps inform health care provider decision-making for patients so it helps the providers and it helps the patients and all that aggregated helps the public health so you might be asking what kinds of questions can Sentinel answer well here's here's a brief overview of some of the simplifications of some of the questions we look at have looked at recently so the number of tablets of a particular drug dispensed to outpatient in 2015 for any year in the last 10 to 15 years depending on what you're looking at or you could ask what is the fraction of patients who fill the prescription who are also filling a prescription for another product or the most sophisticated kind of analysis looks at the risk of a specific problem among patients who use multiple drugs or are very in very specific circumstances so these different tiers of analytic complexity guide the Sentinel systems approach to asking and answering important regulatory questions relating to drug safety I want to take this opportunity to direct you to our webpage Sentinel initiatives org and the reason I'm doing this is not just a shameless plug but also because we really take transparency seriously so everything that we do we post that we're allowed to post now obviously there are things as a regulatory agency that for legal and regulatory reasons we can't post to the public in real-time but everything else that we can we post we want to be as transparent as possible to providers to patients to industry to everyone so that they can see what we're looking at and why we're looking at it and every all the reports are available at this website as well as a whole bunch of other information that you might find useful one of these pages that you might find useful is how is a page looking at how sentinels aria system are asked active risk identification system analyses have been used by the Food and Drug Administration this page is helpful because it connects the dots between what Sentinel has studied and the impact that this analysis has had so you can see for example in this screenshot you can see that we did an examination of the drug levitator a patent or keppra we looked at the outcomes of anaphylaxis and angioedema it was a level one analysis so it was a descriptive analysis and it connects and then we connect that to oh there was a drug safety label change so the drug label changed in part supported by information generated from a sentinel analysis so I encourage you to check out this webpage if you want a clearer picture of how sentinel has been used and the impact it has had for real-world decision making what can patients do this is all well and good but it seems like it it might not be terribly relevant to patients well that's where I would disagree with you patients can engage with the sentinel system by talking with their health care providers and insurance plan about the sentinel system to build awareness despite sentinels having been around as a pilot or as a full-fledged system for over a decade we still have room for improvement when it comes to building awareness and spreading the word about the value that sentinel adds to the public health ecosystem additionally you can visit our website for news and updates about the kinds of projects that we're undertaking and why we're doing them and other opportunities to get involved such as a 10 one of our many public meetings or workshops we want to hear from you we want to keep the doors open and the lines of communication open so that we have patient and stakeholder engagement and input as we continue to build and develop our system so in February this past year in 2018 we held our 10th annual public workshop in Bethesda Maryland I was a two-day affair and we had a terrific turnout over the two days we had over a thousand people attend in person or via webinar and so I would encourage you if you're in the DC area or if you're looking to make a trip towards the nation Capitol or if you just want to dial in from wherever you are to attend next year's public workshop which is going to be in the spring of 2019 so in summary this has been a whirlwind overview of Sentinel which is FDA's national medical product monitoring system Sentinel uses a common data model and a distributed database and it generates evidence to inform clinical decision making which supports public health efforts there are multiple ways to stay informed and active with Sentinel both on the Sentinel website and through next year's public workshop and so with that I would like to thank you and I'm going to turn the ball over to my friend Steve who's going to tell you a little bit more about the efforts of our work group how everyone and thank you so much for attending and thanks to genetic Alliance for supporting this webinar and for Sharon Terry for her leadership minor in genetic alliance but for so many other initiatives and also to be a member of The Sentinel engagement partners work group along with weight attached great both play and share and developed the messages in large part for health advocacy groups and it's been a joy to more with Tyler coral everything right now about vision advocacy I learned I'm still learning from brave and next life a little over three years ago a multi-stakeholder work group was formed to raise awareness about the Sentinel system among four critical engagement partners namely the public health advocacy groups providers them even the health plan members the goal was to inform each of these groups about this invaluable safety tool how it works and it commitment to protect patient privacy looks like the work group was tasked with first creating a plan of action to increase awareness about the Sultana system to shine a light on successes and to articulate the value proposition next we develop customized messages to reach all four target constituencies and receive feedback from all the relevant targeted audience is to focus each story to be both meaningful and relevant next letters all right goof diagram illustrates the interdependent nature of our multi stakeholder work work each engagement partner sector informed the respective Sentinel system stories that I work group developed next slide please our efforts were planned around three foundational principles each of the four Sentinel system stories are open and transparent about Federal's purpose capabilities and successes each story is relevant and meaningful to the respective engagement part the group and the specific relatives as well as dissemination chairs must be effective and understandable for each constituency that's likely to be effective and consistent our workgroup identified the key components of sensible age sorry story called coalesces around each significant element of this safety tool yeah not one size fits all we created stories for four different audiences possessing different interests enemies and yet each to ensure the same information about the schedule system the public and provider stories can be found on the central mission website but most important to us of the risk group is the health advocacy stories we will distribute that story an entire toolkit for your consideration and Humphrey your dissemination to your members looks like each narrative for the forum target audiences include these five key elements first introducing FDA safety mission and the fact that the Sentinel system is only one of several important tools in FDA's toolbox to ensure the safety of medical prevalence to let makes up the central system 3 a description that had works for we provided examples of the central system in action and 5 each story describes FDA's come the patient privacy next slide please of Cairo implicated here is a screenshot of the fentanyl initiative website you can collect epidural michigan.org looks like this now here is a magnified location a reflective assistants doing on the website next like we are focused on the key components featured in the health advocacy and fabric stories for this webinar this particular segment describes an acceptance system works explains how the central system answers basic questions involving large groups and patterns among patients how many people are taking the same drug or getting the same vaccine how many are having bad side effects how many men and women how many are young old pregnant or take other drugs you can fever the head advocacy groups Troy tells the same story but takes a different approach to beat meet the needs of your audiences excellent next mix clue how FDA uses the surveillance tool and when it does with this information can help patients the FDA gets important answers for their sentence system about bad side effects and certain drugs or vaccines the funny sister information along with other information is collected from collisions and drug companies them the FDA decides the best ways commit providers and patients aware of the side effects so zombie FDA can then decide the best way to warn healthcare providers in our patients about taking a medical product next the work group felt strongly about the value proposition for both the public and health advocacy groups the first example comes from a 2012 study involving a new anticoagulant the FDA responded to report about patients taking of this new drug three point received concerned patients breathing too much of the new medication refrigerants with the gathered information not only from patients under new medication but also from a large cohort taking the other medication the result was that the new intervention was no less faith from the older treatment and best patients could continue taking the new location while additional studies were monitoring the safety of the new product next slide please finally the last important element covered the resulting system soit is FDA's commitment to privacy next one now I didn't go to law school because I have artistic ability but this is one of the problem pieces coming out of a worker but largely comes from – they're very talented people using for our and Kathryn Prius a professional operation process if a very effective infographic highlighting these same elements if visually part of the website and part of your media kit at the tap is a very succinct explanation of Sentinel the next four columns describe how it works the commitment to privacy because your questions The Sentinel system F and answers and how the FDA uses the information excellent now we've also provided to you free code as pleasure at media toolkit frequently asked questions to provide a convenient description to have to you in your dissemination in the story then for rapid an answer additional questions I just pause for a moment next slide please these are just for final epic use rip contract information if you have additional concern your questions or comments next play so within your toolkit you will receive Hyperion thoracic copy of both the public's joy and patient advocacy group joy as well as VIP cues now here is the link to the toolkit which has already been posted by genetic alliance to you as attendees and that will also be disseminated following the seminar exercises and again special thanks to every member of the engagement partners work group blade Patrick Lake Sharon Terry Tyler coral for whom I owe a lot on this for his leadership on this work group and also special thanks to Susan a captain in the central operations here thank you so much thank you Steve it looks like we have a few questions that have appeared in the question box and if you have questions go ahead and start typing them in now um looks like Jennifer de Reyes so Tyler I think maybe you can help us with this how did data partners validate that they're converted data ie data transform to the common data model was done correctly how does the Sentinel system confirm that the data transformation process maintained the semantic representation of the data that's a great question so each state of partner has a team on site that whose job it is to maintain the integrity of that data partners transformation to the common data model then so that's one layer of quality assurance and quality control then the Sentinel Operations Center has additional layers of quality assurance and quality control by running standardized queries against each data partners data to make sure that they're getting logical answers to make sure that they're capturing the data that they're supposed to be capturing and to ensure data integrity to two point the one of the main costs of The Sentinel system is insuring the data integrity of such a monumentally large data system and so if we spend a lot of time making sure that the data is clean that the data is accurate to the best of our knowledge and to make sure that the extraction transformation and loading or ETL as we call it is is smooth across data partners and these data partners typically undergo data refreshes depending on the data partner every three to six months and so there's a you know as you know as you can imagine plenty of opportunity for there to be inconsistencies or errors but we go to great lengths to ensure that the data are are transformed in exactly the right way so that they really do represent a gold standard of data quality thank you for your question so there's another question does the Sentinel program monitor over-the-counter products or adverse events and if so what data is used to capture the use of over-the-counter products terrific question the short answer is no sentinel system does not monitor over-the-counter products the reason is that the data underpinning the sentinel system are primarily derived from medical claims like insurance claims and so if the product does not generate an insurance claim it's unlikely that sentinel will will be able to capture it so things like acetaminophen and aspirin are very difficult it's not impossible for the sentinel system to capture so there are some other data resources and other resources in general for capture and description of those over-the-counter products one of the ones at FDA is the FDA adverse events reporting system where patients providers and industry can report adverse events for any product over-the-counter or prescription whatever whatever is is being considered and can be submitted to FDA and I think they get over a million submissions a year I'm but there's an entire division within the office of surveillance epidemiology whose job it is to go through those submissions see if there are patterns they can detect to that warrant further workup and then once there is a pattern that they think could warrant workup depending on the situation Sentinel could come into play but it's a great question it's a limitation of the Sentinel system but it's not one that we've been able to figure out a way to overcome just yet thank you thanks Tyler so we have another question on Susan Thornton so Susan says she is part of the small disease organization that represents and some very few people so how would this data help small patient populations perhaps with no rare disease smaller groups it seems that this data is broader in its application rather than used for specific diseases sure that's a great question so there's a couple ways that the sentinel system can help with those rare disease populations first just by virtue of being as big as it is there's a reasonable chance that that Sentinel does capture some data for people with that disease you know when you're covering tens in terms of millions of people you know even diseases and conditions that affect only you know dozens of people well we can still sometimes see those and so we can go and and evaluate safety concerns surrounding those issues secondly the sentinel system does have the capacity to work and partner with registries at our data partners so for certain conditions that have a tight-knit registry and advocacy community you know the sentinel system tools can connect data from that registry to the rest of the sentinel infrastructure such that that data can be leveraged to answer drug safety questions and so those are sort of the two ways it's scale and its capability to connect to registry I would say are two ways that populations of rare disease people who have rare diseases can be can benefit from the sentinel system thank you can you speak a little bit how sentinel knows what question to evaluate I know SOI used to be the patient rep on mini fentanyl a pilot before Sentinel was launched and when it was in development and I think there was a lot of mystery around you know what what is a signal and then how is that different from doing randomized controlled clinical trials so what what is FDA view when they get a signal or how they detect a signal and then what what happens after that through sentinel sure so that's a great question so sentinel is not really well positioned to be doing clinical trials and so it relies primarily on observational data and that just means data that is collected in the routine course of people going about their lives and you know seeing if we can detect patterns and make any inferences based on that data so to your question about what constitutes a signal and how a signal comes to comes to be the short answer is that there are a lots of different sources of new safety information or new analysis of existing information that can prompt a sentinel workout so to speak so for example if a drug company submits an application for a drug product and during the clinical trials in the application the reviewer at FDA says hey I think that there might be something going on here hey Sentinel would you mind looking at other products in this class that could reasonably be expected to share features and potentially safety characteristics with this product would you look at this and see what we can find and so that's one potential Avenue by which safety information is generated another very common way that we determined to work up a signal is through the system that I mentioned earlier the fair system the federal FDA adverse event reporting system and so that's where patients providers or industry can go online and or in paper if they want and submit reports of adverse events that they experienced while they were exposed or taking a medical product and then if there are enough folks who who say that they had a particular problem or set of problems in the way of taking that product then that would constitute a signal and it's a great question about what makes a signal and it is the question that to be frank a fair number of FDA reviewers would ask as well it's not always cut and dry what makes a signal versus what just makes a loose consortium of associated data that we decide you know may or may not need to be evaluated and so it's a great question but generally a signal is whenever the whenever an FDA member of the FDA review staff says hey I have a concern and we want to make sure that safety is the number one priority for for these for these products so that could be in the course of reviewing a drug application it could also be in the course of reading a journal and saying oh wow they did a case study a case report of this outcome after a after somebody got exposed to a drug that's the problem so maybe we should look at this so those are some of the some of the ways that new safety information and and signals are evaluated and decided to be evaluated upon obviously FDA has limited resources we can't necessarily evaluate every single every single report all the ways from you know and go do enhanced pharmacovigilance for all you know 1.2 million fairs reports that come in every year but we use our best judgment and we have a big staff of clinicians and scientists who can who can really point us in the right direction to make sure that we're doing the best we can thank you so along that line how does the FDA keep the public informed of what Sentinel is is currently looking at because I think you know you've just really articulated that something that may be a signal you know it requires a additional investigation pulling in no other sources of data and obviously you don't want people being harmed by medical products but you also don't want people that may be having safe and effective use of a medical product to stop using it prematurely because you know because of anxiety when that question really hasn't been answered so how do you address keeping the public informed and kind of balancing that while you're answering a question then and then what happens if you do find something that indicates a safety issue what is FDA do then yeah another great question so you know FDA has an obligation to protect the public health and ensure that safe and effective drugs are available to the public across the country they have FDA has another obligation to be reasonable and to be and to not act with that with undue haste in such a way that would adversely and unfairly affect a stakeholder for one of the regulated products so for example if we got a report an unsubstantiated report for a widely used product that didn't really make a lot of sense from a biological perspective and that none of the clinicians were aware of that being an issue and had never shown up before it would be really pretty hasty to then post it on our website to say that we're we're evaluating this this product for this very serious outcome because that would have real ramifications not just for the the drug sponsor or the product sponsor who you know who's who's working to make that drug available but to the patients who are who are using it more importantly and you know it can be very tough to know to know and there's a whole as you can imagine a process at FDA regarding what gets communicated when and to whom it's very tightly controlled so that we don't have any missteps that would be avoidable so for the sentinel system one way that we try to keep folks informed about what we're doing is through our website and so if you go to Sentinel initiative org under the drugs tab you can look at ongoing analyses and these are analyses that SDA has committed to conduct for specific products and to assess the safety of and risk of specific outcomes adverse events problems whatever you want to call them for those products and those have been vetted and are thoroughly thoroughly communicated to both the product to the product sponsor and to the public so again you know we want to make sure that everything is available but we want to also make sure we're meeting our duties as a regulatory agency so what we can communicate we do and at the Sentinel initiative gorg website that's where you're going to get the most up-to-date information about what's under evaluation you great so are there any case examples where you've changed labeling or even you know released public alerts something that's come out of fentanyl yes absolutely and so there in the past few years there have been ranging from inclusion in Sentinel related analysis in a commissioner speech to drug safety communications which is one of FDA's main avenues for getting the word out about a drug safety concern there have also been a lot of safety labeling changes where maybe haven't made quite the quite as big an impact on the headlines but that the drug label has been changed and and Apple or modified in some way and so there have also been inclusion of Sentinel analyses in responses to citizen petition and this is sort of an interesting area of law that I didn't know about before I came to FDA but if it is in petition it is exactly what it sounds like it's where any citizen or entity can petition the FDA to do something specifically or to specifically not do something and so we have a entire office that manages and sort of handles these citizen petitions and Sentinel analyses have helped answer these citizen petitions that are often pivotal pivotal points of communication with the public and engagement with stakeholders and you know the public at large so all of these examples would be available and are available on the Sentinel initiatives org website under the how Aria analyses have been used by FDA um I think that that it also there have also been instances in addition to speeches of presentations before Advisory Committee at FDA where Sentinel analyses have been pivotal to inform the questions before advisory committees which are collections of experts in a given field brought together had to be asked questions by FDA staff and so it's really a and exercise and in making sure that FDA is getting the highest quality information from leaders in the field that is objective and scientifically based so again I would just direct you to the Sentinel initiative org website where that information is available Thanks so on the line we have a lot of patient groups and I know you mentioned that sometimes you can pull in you know rare disease community specific data from registries if they're part of I guess some type of capture through the data partners so is that how it would work as far as FDA getting access to the data and patient registries where they have to have a data partner as an intermediary to help structure some of that data into the common data model or is there a direct mechanism for people to get involved and Sentinel and share their data that's a great question um and I think my answer to that is it's probably both I think you would probably want to explore both options this is something that I don't have a ton of experience with personally and so I think that if if that were something that folks wanted to pursue the best course of action would be to reach out to meet personally so that I could connect you with our colleagues at the Sentinel Operations Center who could provide a much more robust answer about the best course of action for that and so I would I would you know freely admit that I'm that I not the expert on that but that I could point you in the right direction great thanks so much so we're getting on down into the final minutes of this webinar if anybody has questions they'd like to ask please go ahead and type them into the question box and in the meantime what we're seeing if any additional questions come in skis if you could just um you know give us a reminder of you know how patient voice has been engaged in shaping fentanyl and then you know what people can do today as far as you know getting information about the Sentinel story and then sharing it with their patient populations judge break yeah I did good what was what always drove this multi-stakeholder workgroup was raising awareness about this important safety tool and I don't think that I mean if you look at the four stakeholder groups that covers so many different constituencies that have common interests about medical product safety so with respect to the public health advocacy groups representing at this webinar my providers themselves we just we developed along with members of the AMA a separate directive for providers who themselves were fairly unaware of the existence of Sentinel is that how it works okay it's a complicated tension so broadly speaking I believe that top advocacy patient advocacy groups can do a couple things I think it's important to share a rift or respective audiences I guess important at post marketing 50 surveillance tool is not the only tool that FDA uses to keep patient responsibility important a different tool I put that you can refer to at your linear toolkit which provides the health advocacy of vision advocacy group narrative good that that sense forth know how it works provide examples in a language I believe that most people will understand and find miracle within a lot of work then with regard to the common message as well to help members of the public understand at a reading level that is in layman's terms the terms about a very very complicated system I've been working on it for three years I'm just barely scratching the surface about how complex this building system is I could get that by disseminated that will be effective tool I could I could also in checking the website and encouraging more patients to view what Sentinel does how it works what kind of signals it in a large pattern of Erica daily then it get better follows I would let that's another way the patients can be involved I think it is important and I see this kind of has patient advocacy groups also play an important role as kind of a another channel or as as ambassadors by sharing what we learn as patient with our healthcare providers to help them understand that that the healthcare providers also have responsibility to understand the 52 rolls toward that the importance of it in our survey they should be vigilant in following some of the results and outcomes could come from the types of signals that are being studied and by the by the data partners so I hope that responsive I did the greatest task for the workgroup was to just raise awareness we never want this absolutely comes wrongly that it did not want the public and all the other constituencies most importantly patient advocacy groups to be left in the dark about this important tool and to understand it I think that you should also understand that on the Planning Board there are three patient representatives I'm one of them brings another and Sharon Terry is another and we're often there are monthly meetings and we attend goes and raise the patient perspective in those meetings so there's a number of channels in which patients voice is not only represented but more importantly listen to I think at the end of this webinar is to share that message so that you can in turn then hand off to your respective members to share with themselves caregivers and providers thank you so much thanks to how it looks like without one more question just seeking additional clarity coming in from on USS macaroon or MEC around sorry butchering your name if you could just articulate the the differences and maybe the interactions again between Sentinel and net watch sure so um Sentinel and MedWatch are two tools in the drug safety toolkit MedWatch relies on information coming from providers patients or industry to making that information making its way to FDA so that FDA can evaluate so in that respect it's technically a passive surveillance system because FDA is waiting for that information to arrive and if the person if the person who submits that data doesn't take the initiative to submit it then FDA won't necessarily know about it and so that is that MedWatch now Sentinel is designed to be a more active surveillance system and so what Sentinel can do and is developing additional capabilities to do is at go and detect signals and seek out using these data this is one of the big areas of development and send them right now to seek out and use the available data to see if the system can detect the signals on its own with guidance from FDA and from the central Operations Center but if the if these this massive database can be leveraged using new technologies or tree based detection and assessment tools like tree scan or sequence symmetry analyses these kinds of evaluations can be leveraged in such a way that it really becomes a more active surveillance system and so I would I would say that I'm Sentinel and fairs and MedWatch fairs and MedWatch are the same thing they complement each other because there's information that Sentinel is never going to get that will only show up in fairs and there's information that fairs is probably going to miss that will only show up in Sentinel and using the Sentinel infrastructure and tools and capabilities so they really work together neither is going to be supplanting the either because they both serve essential functions thank you thanks so much Tyler so we're down to our last few minutes we know that people on the line efforts day you can immediately go to the website you can learn more about suddenly you can download toolkits and about a week we will have these slides in this recording available on the genetic alliance website Tyler I assume at that point your contact information if people wanted to get in touch about what's in their registries and how to best make use of that and maybe even explore opportunities for the patient reported data to be pulled into this equation and Sentinel sounds like that might be exploratory but that the best route would be to get in touch with you by email is that correct that's correct um if not with me then Steve Makita can can direct you to susan Faro who works at the Sentinel Operations Center and can get you connected to the right people to work with you and answer your questions and go forward okay well thanks Tyler thank you Steve for such an informative interaction today I know I learned a lot and I hope that all the UH the patient groups that are on the line will take the opportunity to go out and share the toolkits and thank you to the FDA in the Sentinel team for the great work that they've been doing and many thanks to genetic Alliance for being our host of this webinar this afternoon and helping better engage patients and FDA activities and safety and surveillance of medical products thanks everybody castrating power thank you all have a great day

Leave a Reply

Your email address will not be published. Required fields are marked *