023: Using Medical Records for Clinical Trial Information and Empowered Self Advocacy


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Do you have a huge 3-ring binder full of medical records that you take with you to your doctor appointments? Have you ever experienced the frustration of logging into your MyChart on your phone so you can share with a provider in another system, important medical information? I personally have. Angelina Massa from Ciitizen shares with me how Ciitizen is putting your medical information back into your hands, helping empower patient advocacy, and taking it even further with clinical trial matching. If you have ever visited clinicaltrials.gov you know how painful this process is. Join us as we talk about how you can securely access all your medical records, securely share them with your care team, participate in real world studies, get matched to clinical trials, and even get paid for your participation - IF you choose to participate.


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Transcript

Tammey Grable-Woodford

Hello and welcome to Your Killer Life, a podcast where we talk about the really real realities of a killer diagnosis like breast cancer with a focus on health, hope, and happiness as we build an intentional killer life.


I'm your host, Tammey Grable-Woodford, and I have a question for you. Do you carry around a three-ring binder full of medical records? I know I do every new doctor appointment.

Well, if you do the same thing, I am here to tell you how to ditch the binder, access all of your records, even more than I had copies of in my binder, and easily share it with your care team. So we are going to have an amazing conversation today. And I'm super excited to share this with you.

Angelina, thank you so much for joining me today. And I am excited, so excited for this conversation. Could you tell us a little bit about who you are?


Angelina Massa

Absolutely, and first, want to say thank you so much to me for having me on the podcast, so excited to be able to talk about Ciitizen and what we're doing. So really, thank you for having me today.

My name is Angelina Massa. I'm a project manager at Ciitizen, been there for almost a year now. And my background is really in operations and project management in health care startups.

And previously before Ciitizen, I had worked on developing recruitment strategies for specific clinical trials, and now at Ciitizen also work on patient recruitment strategies for different recruitment efforts and research and just running the sort of day-to-day to day operations and project management around the company. And my background, and academic background, is in statistics so really exciting to be able to work on research projects that of course use statistics. And so I'm always happy to be able to carry that with me a little bit as well.


Tammey Grable-Woodford

I love it and I love that you said clinical trials and I'll get into that a little more later. But having Lobular, I'm one of those... yes second most common diagnosis, but also still considered rare and just really starting to get some attention and clinical trials being acknowledged as an important part of that. But all right. Let's talk about Ciitizen and what is Ciitizen? Who is Ciitizen?


Angelina Massa

Yes, a Ciitizen is a health care technology company where we help patients collect their comprehensive medical records all in one place through our platform, and it's all for free and always will be for patients so that they're able to access all of their medical records from however many institutions they've seen and been seen at for their care.


We are starting really with breast cancer, so really have started in breast cancer and have worked with a few other diagnoses that were starting to launch, cholangiocarcinoma and rare neurological condition. I'm sure we'll get into that a little bit more shortly.


But we are all about helping patients access their own medical data and really take control of that and choose how they're using it. Whether it's for coordinating their care or finding clinical trial opportunities or participating in research.


So what we do is we work with patients directly to onboard them and help them place medical record requests at the institutions where they've been seen for their treatment. And then we go out and do the work to collect the medical records and make them accessible to the patient on the platform.


And then we're able to do really interesting things from a research perspective as well. Having that information on the platform and extracting key data points from the medical records is a really powerful thing to be able to do for research and helping to advance medical research, too. And only all data is only used if a patient does give consent for it to be used for research studies or things like that. So our hope is that we'll build this really empowering platform where patients are able to both take control of their medical data for their own treatment, but also use it however they would like to if they want to participate in research or share it to researchers.


Tammey Grable-Woodford

I love that. And I have to tell you, when I first heard about Ciitizen and I have to thank Peggy, at the Male Breast Cancer Coalition, because she was telling me about this and I was like, come on. OK, free? And I can get and I can access my medical records because as a patient, getting access to my medical records is sometimes a bit of a cumbersome process. And I did not get, little to my knowledge, I mean, I knew there were things that I didn't get that were that were incomplete.


They were sort of like patient-facing summaries. It wasn't the full records of data. And I joke for those of you that are watching on YouTube or those who are listening to the podcast, not on YouTube, I'm holding up what where I started, which is my little, you know, little notebook we all start with as we get this news and we're writing our panic notes.


And then just for giggles, I also have what was, which is this behemoth of a three-ring binder that I would take with me to doctor appointments. And I always at the front of it had sort of the, or and I said had already. That's great. I had the sort of like the important packet. Right? Of things that if you're not on the same system, here are the things that you're going to ask me about that you can have your team scan and put into my record here at your facility.


I went and filled out my profile on Ciitizen, and within five days my imaging had started to come in and it was kind of amazing because, you know, Angelina, what I noticed is that not only did I have the few pages that are in my binder, but I had access to all of the imaging and I'm six years out. And that was the first time that I saw my cancer. And it was... it... it was an interesting moment.


And I'm so glad to have those records. And it's also exciting to me to have the full record. And I was so amazed at how quickly it all started to come in. And so the fact that you provide this as a free service is really just phenomenal and that you are giving... you're empowering us with this information, which is... which is so cool.


So why did you guys start with breast cancer?


Angelina Massa

Great question, and it's really near and dear to all of our hearts, actually. Our... there's a lot of different therapeutic areas that we could have chosen to start in. And our founder, actually, his younger sister had metastatic breast cancer. Her name was Tania, and she unfortunately ultimately passed away from the breast cancer. And it's really powerful to, that she had actually passed away during the same year when Ciitizen was first founded. And she is really our muse at Ciitizen in terms of every day. And we all have people in our lives, even some of the people who work at Ciitizen too have had a tough diagnosis. And cancer in particular. My mom had breast cancer, and so really close to my heart as well. But we all think of Tania in particular in being our founders younger sister, it's really an important mission to us all.


And so since she had had breast cancer in particular, we thought it would be really meaningful if we started in breast cancer.


And also there are so many subtypes as well and really lots of opportunity for helping breast cancer patients access better treatments, navigate their care. And we thought that that would be an excellent place to start. And we're really happy to be able to now at this point start moving into different therapeutic areas as well. But it will always be very meaningful to the team that we were able to start with breast cancer.


Tammey Grable-Woodford

I am so thankful for that. And I'm so sorry that that that Ciitizen's founder experienced such a loss. And if I remember correctly, he also came... his background is technology. But can you remind me he was was it also in medical?


Angelina Massa

Yes. So it's been a variety of sort of different areas. But he's really amazing. And Anil Sethi, he has founded six companies before Ciitizen. So this is the seventh one. And he's really an amazing entrepreneur and an amazing leader for the company and reminds us everyday of how important this mission is. He... not all of the companies have been in health care, but one of the most notable ones called Gliimpse, also with two "i"s - just like Ciitizen. For anyone who doesn't know the way that Ciitizen is spelled is C-I-I-T-I-Z-E-N.


So it opens all kinds of... you know we get a lot of questions or people forgot. But when I first joined Ciitizen, I would tell my friends "I joined this company called Ciitizen, but it is Ciitizen with two "i"s. And they were like, doesn't Ciitizen always have two "i"s because there's two in the word. So it opens all kinds of little things like that. But so Gliimpse has the same sort of things, G-L-I-I-M-P-S-E.


And Gliimpse, actually amazing, it had been acquired by Apple and sort of powered Apple Health Records. So he worked there for a few years with that transition and then founded Ciitizen. And so not everything had been in health care before for him.


But I think in particular with Tania's loss and just going through the whole sort of treatment journey with her as her caregiver really showed him how important it is to make advancements in the medical space. So much is done with paper records just like you are showing your binder. It's just tough to manage and shouldn't be that way when we have so many technological capabilities that we could leverage. So that was really what brought Ciitizen about.


Tammey Grable-Woodford

It's amazing because even when it's digital records, not everyone's on the same darn system, and so even with digital records and getting providers to share information between hospitals and your primary care or whatever, you still encounter barriers.


So even in even though they say that we have left paper behind, the reality is there's a reason I have a whole big binder of paper.


Right?


Angelina Massa

Exactly.


Tammey Grable-Woodford

Not all systems talk to each other.


Angelina Massa

Right


Tammey Grable-Woodford

So, tell us a little bit about how a patient signs up and also a little bit about data privacy and patient consent, and I think those are all in the same, because I know that for me, that was a big area of concern.


Right. Like, these are my medical records. And so they're going to be in the cloud somewhere. And and what kind of consent and am I giving anything away, anything of mine away in this process? And so let's start there before we get into how do you sign up? Let's talk a little bit about data privacy and patient consent.


Angelina Massa

Perfect. That sounds great, and it is so, so important to the company is that patients feel secure in using the platform and knowing that we have the very best privacy and security systems in place and that everything's transparent with patients, too, about how their data is being used.


So starting with the privacy and security piece we have really invested since the beginning of building Ciitizen and making sure that first and foremost patient data is always secured. And we have a very long page on our website, too, that goes in-depth on how we keep patient data secure. We use the very best security systems through AWS, Amazon Web Services, and we make sure that patient's medical records and all of their data that's being used, even identifiers just having name, email, all of that is so important to make sure that everything is really secured. And so that's always been a real focus for us as a company.


One of our co-founders, actually, Deven McCraw, she is really one of our country's health privacy experts. Amazing person to work with. Before she co-founded Ciitizen she was actually the top-ranking HIPPA regulator under the Obama administration. So truly an expert in the space and gives us excellent guidance on how to make sure today that everything is locked down from a privacy and security perspective and also from a consent perspective.


So getting into your second question around, how do patients know how their data is being used? Our... All of our data is being used everywhere by so many companies every day. And we don't always know how it's being used or how the company is benefiting from our data. We're not always aware of that. So especially with health care, you have really sensitive information in your health records, we want to make sure that patients always know how their data is being used and empower people to really make the choice on whether or not they want to share their data with different parties.


So first, during our onboarding process, which we can get into as well, later when we're talking about how people can sign up for Ciitizen. But right at the beginning in our onboarding process, we will ask patients if they do want to do what we call our blanket research consent. So an overall consent to whether they want to contribute their information in their Ciitizen profile once we collect those medical records and contribute that to research studies. So those would be with Ciitizen's research partners who are interested in running studies with our patient population, a group of patients who we have collecting their medical records. And really, we like to think of it as a community of patients and researchers who are all working together to advance medical research, which are so important.


So patients have the choice up- front during onboarding to decide if they want to do that or if they don't. Either way, the platform is totally free for patients to sign up and use to collect all of their medical records into one place on the platform and coordinate their own care. So if they need, like the electronic version of the binder, you want to just have that and not share it for anything else, that's totally fine.


So we're really happy that we were able to set it up that way so that patients totally have the choice. We're not only allowing patients to sign-up if they are sharing their data for research. Anyone is able to, which is great.


But in addition, we're also having... this goes to your previous point around just being able to get all of the information from different systems that don't necessarily talk to each other in one place. Of course, like each medical institution really has great privacy and security for their own information and will often have the patient portal where you can log in and see your medical records.


And so we often get the question from patients why, you know why they have to sign up for this system where they could be... you know, they're worried about privacy and security and just wondering why they would have to do this instead of just using what's already in their portal. And the answer is really that, like you said earlier, you're not able to look at every system to talk to each other. So it's nice to be able to work with Ciitizen and put in all of your medical record requests across the different institutions. You can see that a lot of patients have either moved cities over the years or have gone to several different institutions even within their own city, or have had genetic testing, for example, at a different facility. So we're able to get all of that information into one place and just securely store it there and allow patients to choose how they use it from there.


Tammey Grable-Woodford

You know, it's interesting because I remember at one point with a new primary care provider at a new facility, and it's not too uncommon. I'm I'm about an hour and a half outside of Seattle, and most of my care was in Seattle. So when I'm actually, you know, not having cancer specific treatment, I was local. And I'll never forget screenshotting a my chart note from my plastic surgeon to upload the screenshot into the my chart for the general practitioner, because even though it was all electronic, there was there was no communication, right?


Angelina Massa

Totally. Yes.


Tammey Grable-Woodford

Absolutely crazy.


So one of the things I appreciated when I went through sign-up was really the friendliness of the patient consent. And I was one of those that said, sure, I am absolutely OK being part of, you know, trials and information. Part of that was because I felt secure in that, too. Can you kind of elaborate on that a little bit, that if you do through the patient consent process and onboarding originally, initially say, sure, you know, I'll share my information, I Tammey Grable-Woodford, am not who they're seeing associated with my records. And how do you manage that? Because I know you will be able to explain this way better than I can.


Angelina Massa

So, yeah, it's such an important question, because one of the things that patients will often ask as well as I do want to contribute to research, but don't necessarily want my name attached to things or to a research study or to have researchers seeing my name and identifiers. So, of course, a best practice in the industry when we're working in real-world evidence studies, in particular, we are providing patients data from their Ciitizen profile to be studied in aggregate.


So really important that each individual patient's identity is not shared with the researchers. So what we do is we will strip all identifiers from a data set before we provide that information over to the researcher so that you will remain anonymous as a patient on Ciitizen's platform.


You will... there may be demographic information, especially in self-reported. For example, we do some self-report like surveys and things as part of some of our studies. And so there may be demographic aspects, but anything that counts as PII, so the real identifiers like your name, any contact information, all of that will be stripped from the data set. So each of our data sets is called de-identified so that none of none of those pieces of information will be included before the information is then shared with researchers.


And then anywhere in our system where your identifiers are attached to your information is securely stored and totally limited access so that it's always kept safe for you and you'll remain anonymous in that way.


Tammey Grable-Woodford

That's fantastic, and it made it so easy for me to make that decision, and I love the fact that even if I didn't choose to do that, I still would have access to my records, access to the portal, the ability to have all of my records in and, you know, to go from a three-ring binder to basically my phone and sharing a link.


So you mentioned "real world evidence." What do you mean by that?


So real world evidence is something I am really passionate about working at Ciitizen. I didn't actually know a lot about before I joined. So definitely an emerging field and excited to get to work on this each day. But so "real world evidence" or RWE as it's called for short since that's a mouthful. Is the basically area of research where you look at secondary data or it could even be patient-reported.


But the whole idea is that rather than, say, in a clinical trial setting that's highly controlled, you have patients coming in for regular visits, going through an active treatment. Often that will always be sort of the gold standard for how we test the safety and efficacy of new cutting-edge treatments in humans. So clinical trials are sort of the gold standard there and probably always will be.


But real world evidence is the practice of really studying the actual data sets outside of that sort of setting, which allows us to really be able to move faster and look at larger datasets because there aren't so many barriers to entry, say, as with a clinical trial. So that we're able to then take a large dataset and really see what the trends are and how treatments are working or certain demographics are responding to treatments in the real world.


So the idea is really that we're able to move research almost faster or look at even more specific research questions by taking these broad datasets that patients either share through a platform like Ciitizen or that's pulled from their medical record or provided by the patient themselves. There's patient-reported outcomes will be reported within surveys that patients can complete as well that can be put towards this type of research. And really, it's an emerging field, super exciting to see platforms like Ciitizen also be able to power this type of research and really bring together diverse patients as well.


Of course, diversity is a huge issue, a huge, huge issue in health care in particular. And it's just so important that we're able to get a critical mass of patients who are usually understudied, put into research studies to make sure that everyone is involved in that type of research and that it's representative. And so real world evidence research shows is really a great step in being able to make research studies more accessible and just overall be able to study the larger datasets without requiring a clinical trial setting. And the other thing is that so I always talk about clinical trials a lot because that's my background.


But with clinical trials in particular, there's so, so many inclusion-exclusion criteria in every clinical trial. Protocol goes on for pages very, very wordy, there's so many reasons why patients can be excluded from a protocol. Whether it is comorbidities or certain treatments that you have been on in the past, are currently on, there's so many reasons why patients wouldn't be able to participate. And so it's really a controlled environment when you're on a clinical trial. And so by the end of the clinical trial studies, you get to a point where you need to be able to see how the treatment is working in mass populations for all, including patients who were excluded from the clinical trials so they never were studied with that.


So real world evidence comes in and allowing us to really see what's going on in the real world once people are actually being prescribed this medicine.


And so one actually interesting study that we've just started working on is related to this in COVID-19 actually so very relevant. And the idea with the study that we're working on is that people are being vaccinated all over the country at a really fast rate, which is awesome. But a lot of people are still hesitant to get the vaccine or aren't sure about how the vaccine will work within their bodies and especially in immunocompromised populations. Cancer patients in particular might be worried about whether the vaccine will really protect them from the virus.


And so we're working on a study where we're going to be working with blood cancer patients to see what the antibody levels look like in their bodies after the vaccine and before the vaccine. And, for example, if somebody has already had COVID. But we will be studying those different levels and how they vary over time and really being able to follow patients longitudinally and get this data collected that could help them in the short term, but also will help us advance research in the longer-term by understanding the impact. So really excited about that study and how relevant it is to right now with the vaccine rollouts.


Tammey Grable-Woodford

I love it. OK, so that is so much information. So I want to pause for a half a second because I want to make sure that I am tracking this. So Ciitizen has free for breast cancer patients and I forget the other two that you mentioned. But medical records, basically a portal where you can have all of your medical records, you will help us collect them. And they are all there for us to access. And we can share that information with our own providers if we want to. And we I, I think we might not have touched on that. But it's a share link, I noticed, because I was looking at it.


Angelina Massa

Yeah, yeah. The Care Team Share, we call it.


Tammey Grable-Woodford

So we have the care team share, which is fantastic. And so that's sort of one element. And then you have this next element that is this real world evidence where you are able to... now with the real world evidence... Are you looking at all of the data or is that still only the data if I say you can look at my data for real world evidence.


Angelina Massa

Yes, so that will always be only if patients have consented to contribute their data in their Ciitizen profile to research, and we actually offer the option to, if at our onboarding you don't want to commit yet, you can decide later. There's no pressure to choose up front. But also, if you want to say no to the blanket consent, then we'll also give patients the opportunity later, if a research study comes up that they're eligible for, they could choose just to contribute their data for that study if it sounds interesting.


So we want to just always make sure that patients are in the know about how their data is being used and if they do want to sort of contribute it to any research studies that come up, then the blanket consent option right up front at our onboarding is great. And actually, most of our patients do select that. But it will always be the choice of the patients.


And even if your data is used for a study, if you've given consent, you'll actually be notified in the form of receiving a payment. So this is something I didn't touch on earlier. A lot of platforms like this, or even if you're just working directly with providers, patients will often be charged to collect the records. Since that is, it can be very difficult, a very sort of tough process.


We lovingly internally call our team who collects the medical records our "Sherpa Team" because they really do the heavy lifting and hard work to go out and collect these records and stand up to providers on behalf of the patient to make sure that they're collecting the full records. But we... I'm so sorry. I forgot my train of thought.


Tammey Grable-Woodford

Oh, no, don't worry. So there's just so much. So we were talking about payment. And that's interesting because, you know, as a patient, to feel like I have any control, especially as a cancer patient, OK, because like, that's the first thing that you feel goes out the window is any kind of control over anything.


All of a sudden you're on the cancer train, you're being given options to choose from that you would never choose for yourself. And it's... you just feel like you're stripped of any kind of control. And then I also know that, you know, with some medical consent forms I've signed, it's entirely possible that my tumor tissue made its way to a lab somewhere and, you know, without my knowledge. And that's something that can happen in the medical industry.


And so it's so interesting to me that with Ciitizen, not only do I have control over my medical records and how I want to share them and whether or not I want to participate in trials or in real world evidence. But then you guys also do this thing where you further empower patients through some sort of compensation. And I found that to be kind of crazy because nobody does that.


Angelina Massa

Yes, yeah, so it's definitely it can it's common that patients might be charged, whether they want to use a service to collect their medical records or go directly to providers.


And we would just never, never, ever want to charge a patient for that service that are core of our business. Patients are going through enough. They don't need to deal with the time and effort of reaching out to providers, but also monetary costs so it will always be free for patients. And in addition, we want to make sure that the value of the that you're creating for research with your medical data is then given back to you in some capacity.


So we share some of the revenue from our research studies back to patients so that if your data is used for a real world study or engagement like that, then you will be paid for that. And so these amounts are significant too. We've had research studies where we would pay a patient say twenty-five dollars, could be up to one hundred or two hundred dollars for one project and one research project, whether there is whether the patient is even contacted or not to do something for the studies.


So we... What I mean by that is that there will be times where a patient has already given their consent and so we will share their information with a researcher. And then we don't want to just sort of hide that in the background. We want the patient to know that their data was shared, even though they haven't taken an additional sort of step for that particular study. We want them to share in the value. So there's sort of this mentality in the industry that patients should only be paid the amount of effort almost that they put in. But what we want to do is really share the value that they've created. And there's immense value in sharing your medical data as part of a research study.


So that's why we care so deeply about making sure that not only patients aren't paying us for the service, but also that we pay them for the value that they have created there.


Tammey Grable-Woodford

That's amazing. That is absolutely amazing to me.


So how does Ciitizen data then end up... and you've kind of you've kind of talked about it, so I get kind of stitched together, but I wanted to ask the more specific question of how does the Ciitizen data contribute to the real world evidence?


Angelina Massa

Great question. So how it works is that with most real world evidence protocols that are put together, there will be some specific criteria for who is eligible for it. So similar to a clinical trial. But the criteria will usually be much less stringent than a clinical trial. So so what will happen is that there's a certain study design and research question to each real world evidence protocol and study. And what we'll do is, is look for the patients on the platform who are eligible for an engagement and contribute their data for anyone who has consented.


We would put that information into a data set that's that's sent to the researchers to ultimately use to run the analysis. So it can vary a little bit based on what the research question is. But there will usually be criteria such as diagnosis, always important. And also in staging, there could be some studies that are focused on a metastatic community, for example. So not every patient will be eligible for every single study, but we'll identify the group or cohorts to go towards each one.


And I haven't even talked about this yet, but we have a very in-depth data extraction process, which is a huge part of our business and operations, and that's what's really innovative about our company. So what we'll do is extract the data from the medical record and put together about data for the study cohort into the data set that's ultimately delivered. So I'll talk a little bit about that process, because I think it's super interesting. We have, you know, even in electronic form, medical records will still be hundreds or even thousands of pages.


So it's super helpful to be able to just have access to that in PDF form via the platform. But even that can really be overwhelming still. So what we do with each patient who onboards to Ciitizen is once we receive the medical records, we go through a data extraction process from those records to pull out the really important pieces of information, along with the dates tied to each of those pieces of information within what we call the cancer summary you might have seen in the top of your profile, or if you just signed up, it might not be there yet.


But there is a cancer summary that we will publish as soon as we have collected the records and extracted the data. And the way that it works is we use the machine learning pipeline to go through really scanning all of the records that we have, which can be thousands of pages per patient and really overwhelming amounts of information in there. And it will produce all of the statements of information that's relevant. So diagnosis, molecular type, histological type, things like that, comorbidities, medications.


And we'll pull out those pieces of information and then have two rounds of human review as well. So we have a lot of great medical expertise on our team and a whole team that goes through and reviews that information to make sure that it's accurate for each patient before their cancer summary is posted. And then on the patient end what it looks like in our platform is that you can click through the really nice user experience. It's an easy-to-use interface. You can select which pieces of information you want to look at and then link directly into where in the record that statement was found.


So instead of sifting through hundreds of pages, if you want to see where your staging took place, you could click on the stage. We call it entity with data variable you could click on, so the stage entity. And first of all, it would it would show any of the times where you've received a certain stage, or result, then you could click on each of those pieces of information and it'll pop up with your records in the exact place where it showed up, which is really great for being able to click through and make sense of the information.


Tammey Grable-Woodford

That's amazing, because I will tell you already for me, just going through the records that are coming in and you're right, I mean, you know, 50 to 100 pages per document that is come in. And then, of course, there's the imaging and the imaging reports. And so that is amazing that you all are able to create a summary for those of us using the platform.


Angelina Massa

Yeah, and it's really great to because that extraction process serves a dual purpose. Both for the patients are able to to use that interface and also pass it on to doctors. Like you said, we have the care team share, where if you want to share your entire medical records with another provider, you're able to do that. And then they would be able to see that information as well and click straight to the pieces of information that they are trying to look for. So the extraction process is very important for what patients are experiencing when they're using our platform. But it's also how we put together a data set that then goes to the researchers as well, because we're extracting all of the key pieces of information.


And then, for example, stage would be one of those that's probably included in the data set for a real world evidence study. So we've extracted that piece of information, tied it to that patient, and then we include that within the data exports.


Tammey Grable-Woodford

That's amazing. Absolutely amazing. All right. So we talked about the medical records component and we have talked about real world evidence. And then your background personally is in clinical trials and you've mentioned clinical trials a couple of times. And so it sounds like that's sort of the third pillar, third leg of what you've got going on at Ciitizen. Want to tell us a little bit about that?


Angelina Massa

Yeah, absolutely, yes, and this was one of the reasons I wanted to join Ciitizen even it's just it blows me away every day.


But we have worked so hard with an amazing team to put together a really incredible clinical trial matching technology. And we just rolled it out, making it live to the breast cancer and cholangiocarcinoma communities starting in 2020. And what the technology does is takes all of the clinical trials that are available on clinicaltrials.gov. So I don't know if you've personally used clinicaltrials.gov, but it is very hard to use and navigate. And so what we do is instead of making patients sort and filter on the website and then try to read through every single trial and figure out what they qualify for and then look for location sorting - such an overwhelming process.


And like I mentioned before, there's just so many IE criteria for every trial. It's hard to navigate and understand what you would be eligible for. So our goal is to help patients move away from having to search for their own trials and instead be handed a report that includes all of the clinical trials that they are a fit for. So we'll match against all of the five hundred plus clinical trials on clinicaltrials.gov that, so breast cancer, let's take breast cancer as an example.


There are over five hundred trials that breast cancer patients could be eligible for. And we've actually also added a few hundred more that are for any patient with a solid tumor could be eligible for those as well. So we're even including trials that you might not specifically find if you're looking for breast cancer only, but breast cancer patients are eligible for them. So we have this really comprehensive database and that's how we start.


We have this team of annotators who will go through every single protocol, navigate the clinicaltrials.gov information, and then code it into a format where we're then able to match their notes against all of the information within your cancer summary so that we can do a direct match to figure out which trials are a fit for your specific goals medical history.


And for me working and I really have worked in clinical trial recruitment processes for a while now. And what's always been tricky is that pre-screening component and especially working off of sort of patient report, which is often how clinical trial matching services work, it can really be tough for patients to recall every single thing. They might have never even been told certain pieces of information that would be needed to figure out if they are a fit or not for a clinical trial.


So the challenge is always getting access to the medical records so you can see that information and really have a source of truth of all of the medical history.


So just so much power and having all of that information for yourself on the platform with Ciitizen and then being able to use all of that to figure out which clinical trials you might you might match to. So so that's how it works.


We go through the matching process and then we create a report that's delivered to patients where they can see the whole list of trials that could be a fit. And it will include also sort of a tiering system where we're not going to say that every trial that's on there will be like the perfect fit the matches against all of your information will actually highlight the best fit matches at the top of the report, but also show the ones where maybe we're missing, that you would need a lab test done or something like that to determine if you're eligible. And so those are the types of trials where patients might not even know to look or wouldn't otherwise see on another service that that's an option for them as well. But they might need one more piece of information to then be a perfect match for the trial.


So our goal is to give as much information as possible about which trials are the perfect fit and which trials could be a fit and why.


Tammey Grable-Woodford

That's huge because clinical trials feel absolutely elusive and cancer, cancer land has its own language and someone who is newly initiated, especially when newly diagnosed and frankly, while even while you're going through it, you're constantly trying to keep up with all of the information coming at you with regard to your diagnosis, your subtype and all of the different variables that have to do with your unique body and your unique cancer.


And so it's amazing to me that you guys are able to take that information and have streamlined that process to be able to cross-reference because it can feel a little hopeless and overwhelming if you're trying to figure that out yourself as a patient. And then not all doctors and hospitals participate or even know.


And so it seems like that it's almost sort of you have to be I don't want to say lucky or fortunate, but in a situation where you're in an environment with a provider who's in a nurturing environment for clinical trials in order to even know the options or if there are options. And so this is amazing.


Angelina Massa

Exactly, that's exactly how I feel, I can take no credit for developing that technology, I'm just eternally amazed by how they brought that together.


But I totally agree. It's so important that patients know about all of the trials that are out there that could be a fit for them versus just what's available at their institution and how our doctors themselves even supposed to know every trial that could be a fit for their patients. You're not going to memorize five hundred different clinical trial options and their in-depth protocols. So it's just, you know, it was such an important area that technology could help with versus relying on traditional methods of sort of, you know, remembering different protocol criteria and then enrolling patients from a specific trial site into it.


So important that you know, knowledge is power and patients should know which trials they're eligible for, whether it's at their own institution or another one.


Tammey Grable-Woodford

And I would also think that, you know, as a patient, some providers are better than others. And I don't want to ditch on providers here. But when you're a patient bringing information in and you're a provider who's already overwhelmed with your patient load for the day and a patient says to you, I might be eligible for this clinical trial, I can imagine that it might be received differently if you're able to bring all of the information to the table, which is it sounds like this report would allow you to do.


So. So you have, as a patient advocating for yourself, it is yet one more tool to substantiate your position and your needs and to use in your advocacy toolbox.


Angelina Massa

Exactly. And we've actually gotten great feedback from doctors as well in those settings where patients do bring this as a tool to one of their appointments with their oncologist. And they bring in the reports. We've only had this, the tool, live for less than a year, actually, but have gotten great feedback from patients who bring the report to their oncologist and they say, "Where did you get this?" and are blown away that the service exists. So I just think it's so exciting to get that kind of feedback, too, from real expert oncologists who are really amazed at how this is working and how granular the matches are, too. So that's been a great thing to see. Both for patients it's really valuable and a great tool, just as you said in your advocacy toolbox, but also for doctors, it can be a tool as well, since they won't always know every single trial that's out there. And if a patient comes into an appointment empowered with their list saying "Which of these looks like the best fit for me?", it's a great jumping off point for a conversation with your oncologist.


Tammey Grable-Woodford

And it's so awesome because it's also such a seed for hope, I think is another, yes advocacy, but also hope. And you just cannot underrate the importance of that.


So you have your real world evidence, you've got the medical records, you've got all the work that you do with clinical trials, you have it sounds like a relatively labor-intensive because you are double-checking, cross-checking. So you've got your AI, but you've also got humans that are actually going through the process and double checking that the AI is correct


And so I guess that next question I have is how is this no charge for the patients? And yet not only is it no charge for the patients in some ways, in some cases, they can even not only provide some sort of remuneration but also and I don't think we touched on this the end result. So you're not just sort of giving the information away and hoping for the best. But if I understand it correctly, if I participate in a trial, I also get feedback on the other end of that. Is that correct?


Angelina Massa

Yeah, so great questions all around and actually very similar to what my mom first asked when I joined Ciitizen. She has breast cancer herself and had experienced a lot of this just, access to information can be so difficult and just tracking everything that's going on when you're already dealing with a diagnosis and navigating your care. And the first thing she asked me when I was all excited telling her about Ciitizen was, how is this free? You're going to get a lot of questions from people about how this is free. And she was so right. That's one of the first questions that patients often ask and almost raises skepticism, even though it's great that it's a free service - it almost makes you wonder what's the catch. And the amazing thing is that there's no catch. You know, the way that we're able to make it free for patients is that we work with researchers to run these studies and the researchers will pay Ciitizen for the information that we are able to provide. That data to be analyzed for the study. And then from there, we're able to share some of that revenue back to the patients themselves, which is great, but it also powers the rest of the business. So everything that we do through all of our operations teams to collect the medical records, to extract the data and to the levels of human review, all of that is really powered by our research partners and clients who are paying us in order to power the research.


And so on the patient end, patients often will choose to contribute to that research. But once again, it's not a requirement for patients that don't want to. So that's why we often get patients who wonder, how could I sign up for this and get the benefits but not be paying for it. So that's sort of the first part of the question.


And then were you also asking for clinical trials, in particular, if patients get a benefit after participating in the trial information?


Tammey Grable-Woodford

Or the information. Do I have access to the overall results from that clinical trial or will that be shared with me, or is that just sort of you know, not that I've participated in one yet, but let's say I participate in the one that's coming up that we'll talk about in a second, which I do plan to do. Do I have access to what the results of the trial or the study would be?


Angelina Massa

Yes. OK, great question. So for real world evidence studies, one of the exciting things about our platform and the model is that we will be able to share back information after a study is complete. We will ultimately there will be publications at the end of each study and we'll be able to share with patients that they made a contribution to research that was powered on Ciitizen's platform. And here's the results of that.


With clinical trials themselves, we, unfortunately, don't have that sort of level of power to be able to provide back the information about the clinical trial performance itself, because each clinical trial will still be operated by the specific pharma company that's sponsoring it.


And so in those cases, it's highly, highly regulated, and pharma companies typically aren't able to give that interim feedback back to patients as they're participating in the study even. So. So that's one area that's really highly regulated and patients won't necessarily know the results.


But with real world evidence, they... there will be publications out there that are using Ciitizen patient data, which is super exciting. And patients will know as part of Ciitizen's platform that they've made that contribution vs. for other companies in the industry, that often will be extracting data from your medical record without your explicit like you've given informed consent, like via a platform sort of thing. So that information like your data might be out there being used in research studies, and you have no idea that you are one of the one thousand patients who was included in that cohort, for example. So it's a really cool thing about Ciitizen in my opinion, that patients will be able to get some level of feedback, at least from the research surveys and real world evidence studies that they participate in.


And then on the clinical trial end, they will receive their full report that shows all of the clinical trials they could be eligible for. But then what happens post-randomization or enrollment into the trial will be sort of run separately, Ciitizen isn't involved right now in the operations of running any of those clinical trials, but we'll help connect patients before they enroll.


Tammey Grable-Woodford

Gotcha. Thank you for clarifying. And that is really exciting, actually, and totally get it on the clinical trial side. Absolutely makes sense on the real world evidence side. Having the ability to give a) permission in the first place, and b) potentially actually see the end result on anything is kind of amazing when you think about it. So I love that.


So the I just want to give the u r l.. But I do have another question or two for you.


So for those of you that are listening, it's ciitizen.com/yourkillerlife, and if you go forward slash your killer life, that lets them know that you heard it here, which is always awesome. And that's where you can sign up like I did, and start to get your medical records all in one location. That is not a three-ring binder on a shelf somewhere.


And a question I had. I have global listeners and I know somebody is going to ask this question, are you United States only, and do you have a roadmap for looking ahead to maybe other countries that you may be working with?


Angelina Massa

Yes, so at the moment, we are only based in the United States and running this whole sort of service for patients who live in the United States and have received care at institutions in the United States. But we do hope to expand to countries across the world as soon as we can. And we do have a roadmap for sort of how that will roll out and how we'll be able to expand Ciitizen to and open up to patients in other countries.


And right now, probably the best way to express your interest would either be to still sort of enter your contact information on Ciitizen's page that you just provided the URL for or to email us at support@ciitizen.com. So if patients email us directly, really with any questions, always happy to help with anything. If you need support while doing the onboarding to Ciitizen, if you are in the United States or just interested in when we'll open up in your country, can always reach out to us and support@ciitizen.com.


Tammey Grable-Woodford

Awesome. And I have to tell you, I'm embarrassed because I forgot her name already. But you're onboarding, the person who helps with onboarding her picture is in the onboarding screen.


Angelina Massa

Mequel, yes.


Tammey Grable-Woodford

She is amazing. And I did have because throughout I was one of the labs that was like, we need more information. And I didn't expect to encounter a human in this process. Right? Totally expected it to be pretty much automated and to actually have customer service. And I can only imagine how important that can be, especially if I think back to when I was first diagnosed versus now, you know with overwhelm and fatigue and coming out of surgery and prescription medications and all of that stuff.


To have an actual human as a resource where needed through onboarding, I thought was really amazing and just incredible that you guys do that.


Angelina Massa

Oh, I'm so glad. And what we did make our last update to our onboarding flow, that's what we put in her photo, because who better to be the face of Ciitizen's onboarding than Mequel? She is so wonderful to work with and is one of our support team, she really leads support. So any questions that anyone has definitely reach out to her there? I would love to make one note on the onboarding about that driver's license step, if that's OK.


So most of the onboarding process super straightforward. You'll just answer each of the questions that are on there. We ask patients to fill in contact information, fill in the providers who they've seen, our institutions that they have been to for their treatment, questions about diagnosis, things like this, super straightforward, self-explanatory.


But the piece that we always get the most questions about is the driver's license stage. So I'd love to give a little bit of background on that.


If you do go to ciitizen.com/yourkillerlife, you'll see that through the onboarding you get to a point where you're asked to take a photo of your driver's license and then provide your signature. And particularly people who sort of just come across Ciitizen and then start going through that process are wondering why is this company asking for my driver's license, this very secure piece of information. So that is the piece where patients have the most questions. So just wanted to talk through it. What comes with working with the HIPPA right of access, which is what we leverage on behalf of patients to be able to then go out to their providers and collect the records is that we need to provide proof of identity. So if we were to just go out and say, we need your records from the provider, they're not going to give it to you without a rigorous process for verifying the identity. So that's why we ask for usually the easiest form of identity is taking a photo of the driver's license.


So that's why that's a piece right at the beginning during the onboarding since it's required for any record request that we make to institutions will require that we have that I.D. and signature. So that's just one piece I wanted to clarify and give people a heads up about.


Tammey Grable-Woodford

You know, I was thankful that you did from my side because, you know, if that wasn't something that was required right then it seems like folks could just have accounts opened up and records collected.


Angelina Massa

Totally.


Tammey Grable-Woodford

Yeah. So I was relieved at that extra step of verification on my end. And then, of course, as my records started to come in and I saw the request as the cover pages and I saw my driver's license and my signature, that kind of looks like, you know, how it is when you sign on a computer. Kind of looks like my signature. It all absolutely clicked and made sense.


So did you want to take a few minutes and talk about the upcoming study and kind of what that is and when that is and whatever information you can tell us about that?


Angelina Massa

Yes, absolutely. So we've talked a lot about real world evidence, so excited to share a real upcoming opportunity called the Breast Cancer and COVID-19 Research Study, and this will actually be kicking off this week, so the week of March 8th. Patients will be able to start participating in this study.


And the first step is really that verification and set up of the of the Ciitizen account. And then the second piece will be completing a study questionnaire where once again, it will the data will be de-identified. But you'll be invited to fill out a 20-minute long electronic survey that would be emailed via a secure link. So patients will basically fill out their questionnaire providing information on how the covid-19 pandemic has impacted their lives and their treatment.


So one clarification is that patients don't need to have had COVID-19. Just breast cancer patients were really interested in, and the main research question here, what the study is, how the pandemic itself has impacted patients with breast cancer, because obviously there have been huge interruptions to care, to screening, to all treatments. So we're really interested in sort of quantifying that impact and hearing patient voices in expressing their experiences during the pandemic. And so that's really the goal of this study.


And it's a great example of what we talked about earlier, where the power of real world evidence is that we're able to take information from a patient Ciitizen profile, so that's what's called the secondary data and then connect that to patient reported data to have this really powerful connection of medical record, verified data along with patients experiences, how the pandemic has made them feel, how it's impacted... have they been seeing doctors like this... via Zoom, or just like how has it impacted their lives?


And so really interesting study questionnaire and will be linking together patients' Ciitizen profile data with the patient responses and sort of analyzing that as a whole to understand the impact of the pandemic. So that will be... this is great timing as it's kicking off this week and hopefully members of your community will participate.


One thing to note here as well is that it will be for patients in the United States in particular, who have been diagnosed with Stages 1 through 4 breast cancer. And even if not a current diagnosis, patients who have been either in treatment or monitoring at this time will be eligible to participate. So really excited to have this launching this week.


Tammey Grable-Woodford

I am excited that there is a study because I can tell you in the survivor groups, you know, the things that I'm seeing that, you know, delayed reconstruction, delays on getting in for scans and appointments, I myself have delayed it. I'm like, I'll just do my scans in a few months forget about it. It'll, you know...


And so it is definitely impacting and especially on the reconstructive side, which is interesting. So I'm curious, I think this is going to be an amazing study and I'm hoping that many of my fellow breast cancer girlfriends and girls and guys, gals and guys that fill this out because this is it has been quite, I don't say damaging, but you actually could.


But it's been it's definitely had a noticeable impact for those with breast cancer, which is the only community I can really speak for, I'm sure it's impacted many other communities as well. So that's exciting.


OK, so again, that URL, and everything will be in the show notes and just a reminder, you guys, the show notes on YouTube will have the links. And then, of course, on the website at yourkillerlife.com and the show notes on your favorite pod player, all of them will have the links.


The URL, it is Ciitizen with three "i"s, I guess which is ciitizen.com/yourkillerlife and that will take you there. If you have questions along the process. I can tell you from personal experience, for me it was as easy as hitting a button and reaching out. The support was amazingly fast. So that was also something I didn't expect. You know, sort of you sort of expect, especially in a chat or something, that it's sort of we'll get back to you tomorrow kind of thing. And could have just been my timing, but you all were absolutely amazing.


Angelina Massa

Oh, so glad.


Tammey Grable-Woodford

So before we wrap up, though, is there anything else that you want to talk about that you want to leave us with Angelina?


Angelina Massa

I... You know, I think that this was such a good such a good discussion, and I really thank you for welcoming me onto the show and also for you individually being a part of the Ciitizen community, that really means so much. And so I just really want to thank you for the opportunity, but I think we've had a great conversation, covered a lot of bases.


I have a tendency to really talk a lot and for a lot of information out there. So thank you for baring with me. And it's been so wonderful to get to talk to you.


Tammey Grable-Woodford

Oh, thank you so much. Good information. And thank you so much for coming on the podcast. And this is... I'm not kidding. I actually sent a note off to support. I think you might have seen it where my subject line was "I could cry" because I had never had this much access to my information and to have it at my fingertips and not have to beg and plead. But it just showing up has been, you know, kind of life-changing, to be quite honest.


So I am such a huge advocate and I have been a huge self-advocate all through all of my treatment. And man, I wish I would have had this in the very beginning when I was first diagnosed. I really think it's a game changer. So thank you. And please thank the team for all that they do.


Angelina Massa

For sure I will. Yes. That's so great to hear.


Tammey Grable-Woodford

Awesome.


And as far as you, my listener. Oh, my goodness. Thank you so much for listening to Your Killer Life and don't forget to like subscribe and more importantly, share so that we continue to help each other advocate and to continue to inspire one another. For more information about what you heard on today's show, check out the show notes, as I said, or visit us at yourkillerlife.com and don't forget to join us for a live after the show conversation on Clubhouse Wednesdays at 5:30 p.m. Pacific Time.


And if you don't know what Clubhouse is yet, it's the newest, greatest like we needed another social media app, but we have one and it's all audio. So you're actually talking with us live. So real conversations.


Last week I had a FABNO, also known as a naturopathic oncologist, on. And this week we've got even more fun stuff. So be sure to join us out there. And until next time, keep building Your Killer Life.

Remember the conversations you hear on the show are based on unique experiences and varying diagnosis. And we all had our own medical teams. We are not giving medical advice. So if you hear something inspiring, please talk with your providers.

#breastcancer #medicaladvocacy #yourkillerlife #yourkillerlifepodcast #ILC #bilateralmastectomies #cancersurvivor #cancertrauma #cancerptsd #cancercaregiver #lymphoma #boobiecrowns #lifrauminisyndrome #lobular #aestheticflatclosure #BRCA #BRCAChatter #previvor


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