Transcribed by Agnieszka Kowalczyk
Laura (addressing Martin Naley): It’s my pleasure today to be speaking with Martin Naley from Ciitizen who is the program lead for clinical trials. You have an amazing background, having worked for the Biden Cancer Institute before and having had over a decade of experience working in clinical trials. It’s an honor to be speaking with you. Thank you for taking the time to join us today.
Martin Naley: It's a privilege to be here.
Laura Carfang: We get questions all the time about clinical trials. What is it, how do I get involved etc. It can be quite an overwhelming process. But it doesn’t have to be. How would you define a clinical trial? What is it that the patients need to know?
Martin Naley: Clinical trials are something that every patient should be thinking about at every step of their care. The nature of cancer is that it's full of big decision moments and when you hit one of those decision moments, you need to consider what the next line of therapy is to go for.You have to be thinking almost like a chess game, always two steps ahead. What are you qualified for today? What could you be qualified for tomorrow? What decisions can you make today to get yourself ready?
Often people think about clinical trials as one of the last things you'd think about in your care, I like to think about them as the first thing you ought to be thinking about in your care. Trials for brand new drugs are typically ones where drugs are introduced at the end of care. But trials move forward in the care journey from the very end, to second line, to first line, all the way to the beginning of cancer, and so some of these new treatments become available at the beginning stages of your cancer.
Laura Carfang: That is a really good point. I often think we have this misconception that clinical trials are only an option when all of the other options have been exhausted. But what I'm hearing is that even in the earliest stages, these are initial conversations you can start having with your oncologist and with your medical care team about what options are available and whether or not, depending on the phase and stage that you're in, if you're eligible for any of them, Am I understanding that correctly?
Martin Naley: Yes. Furthermore, if you don't consider a trial today, you might actually take on another line of care that prevents you from getting that trial tomorrow. You need to be able to think about those trials as equal to standard of care options. They are often considered therapeutic options today. That's really a change in the medical mindset, it's not just research, it's an opportunity to get the best therapy. Wherever you are in your care, when you hit one of those decision moments, that is when you ought to be talking with your oncologist and exploring every opportunity.
Laura Carfang: That's a really good point. Speaking of clinical trial eligibility, would being on a specific line of treatment preclude you from being eligible for other treatments later down the line? Or even the reciprocal? If you started off with a Taxol, or an AC treatment, would that preclude you from participating in a clinical trial? How do we find out that information and with whom should we be speaking to about it?
Martin Naley: The information is available in a public place, it's just impossible to read it there. It's unfortunate. So there is a place called clinicaltrials.gov. All clinical trial sponsors are required to register their trials there, you can think of it like the trials phonebook. But it's written in a language that nobody understands. Even oncologists have difficulty understanding it. I often say it's written as riddles. Not only are they riddles, but they're riddles in a foreign language, not only do they lose their meaning but they even lose their humor.
The challenge, I think, and this is what I've been working out for the last decade, is to bridge a language gap between what's found in a patient's medical records, the language that's spoken in, which is medical terminology, and clinical trials selection criteria, which is a completely different terminology. For instance, in your Taxol question, there are many different drugs that have their own names, Paclitaxel, Abraxane for example, that are all taxanes. A clinical trial may require that a patient has had a certain number of taxane treatments so getting that round of the next treatment of Taxol could be the thing that qualifies you for a certain trial. At the same time, if you've already had a line of taxane therapy, and a trial has a limit of patients who have only had one before, then you could actually exclude yourself from that trial by accident. That’s why it's important to have the list of trials that are either available to you now or could be available to you soon so you can start making those decisions together with your oncologist. It's almost impossible to do that research on your own. That’s the work I've been doing, essentially delivering reports, lists of trials to patients that they're eligible for today, or that they have a qualification path to get to for tomorrow.
Laura Carfang: It’s getting as much information as you can upfront so that you can make informed decisions about your overall lifecycle treatment plan, not just in the immediate. I know so many of us who are listening and going through this, we are forced in a very short period of time to make these critical decisions, because the cancer is aggressive or growing, or we got diagnosed at that particular stage, that we don't have a lot of time necessarily to do the investigative research or even to know that this is an option for us. I really appreciate you bringing that to light.
Martin Naley: These decision moments are “oh my gosh” moments where everything is brought into focus in that moment. Unfortunately, the research that you have to do to find your treatment options, takes a bit of time. Having the luxury of a report that gives you that information can really help in those discussions with your doctor. What you don't want to have happen is that the information gets to you after you've had the interaction with your doctor and made a decision. It's just too late. It’s important to make that request. Get your trial options report as soon as you can.
Laura Carfang: Can you tell us a little bit more about your background? And what is a trial options report?
Martin Naley: I'm a biologist with a business background. I worked in a company that helps to bring genomics into the world, a company called Invitrogen which became Life Technologies. Working with that company, I had a chance to develop and introduce some of the first genomic sequencing tests for cancer. I was really excited about them. I definitely got some religion about that technology. I was disappointed and impatient about the uptake of that technology in the world. So I started a company called Cure Forward, that company doesn't exist today. What it did was help patients get genomic sequencing tests and gather their health information, and then use that information to get into clinical trials. In doing so, I learned this language gap and I also learned what investigators, the people who run trials, need to see for a patient in order to make that patient qualify for the trial. I learned about how difficult that is. There are a lot of places out there where you can get superficial clinical trial matching. Sometimes those places ask you a few questions online, what your cancer type is, and so on. Some of the questions, if they wanted to go deeper, get too hard to answer for a patient. So they don't. You wind up with superficial matches. I decided to make something that would be a lot more rigorous.
The risk of being almost impenetrable to most users is actually making it understandable, this being a set of matches based on every aspect of your medical records, that would qualify you for the selection criteria in clinical trials. I started doing that when I was at Cure Forward and from there, I had a chance to work with a number of different companies and organizations like the Biden Cancer Initiative to solve this problem, and unfortunately, it just hasn't been solved yet. I was really lucky to meet the founder of Ciitizen who was bold enough to take a chance on this project. What's really distinctive about this project is that I made no compromises. The world is full of compromises on clinical trial matching and an example of a compromise is you might go to an institution that has a wonderful set of trials available but it's never going to be all the trials. Even if you're at an elite academic medical center in one of the cities with the best doctors, there could be another trial down the road that you don't know about. The compromise could be the breadth of trials that's available to you, or it could be the depth of matching. I decided to take neither of those compromises. This gave me a chance to do that.
What we do through this software is take all of your medical record information and compare it to all the clinical trials and deliver you a report. It's a list grouped by the degree of match strength, and the location matches to your travel preferences. Within that report you see, first the highest level matches within your location choices and then last, you see the partial matches outside of your location choices, and everything in between. And it's available now. It's my dream that I've worked on for a decade now and I got a chance to make it with a company that really cares about making this possible for patients.
Laura Carfang: Congratulations! I'm just so excited to hear about all of this coming together and how you are not making any compromises to create the best tool possible to help the patient find that match and to talk about the role that technology plays in our healthcare and our health system.
Martin Naley: In technology there’s an acronym that everybody uses called MVP. That's the minimum viable product. What's the least you can get away with and get on the market? Well, unfortunately, in clinical trial matching the MVP is everything. And that's just what we had to do. If you did anything else, you're delivering superficial matching and the consequence of that is a patient getting hopeful, and organizing their care around something that doesn't exist. Then the investigator has to give that patient bad news, that they're not actually eligible for the trial. It's terrible for everyone, bad for the patient and for the investigator. The world gets jaded. Then everybody stops, the doctor stops looking for trials, the patient stops looking for trials, the investigator stops taking the referrals, they just don't pick up the phone. And, and so the MVP is you have to do it perfectly to overcome this fatigue that the world feels so that people can actually believe again. That's what we're after.
Laura Carfang: Before I bring our panelists on to join our conversation, one last terminology question I have for you. So as people are getting their matching based on their medical records, and they're getting this report of what trials they're eligible for, does your report also break it down based on Phase 1, Phase 2, or Phase 3 trials? And then specifically, how are those trials differentiated? Can you explain a little bit what the difference is between Phase 1, 2, and 3?
Martin Naley: For the first question, the answer is yes. Within each of those four trial groupings that match strength and location, the support order is by phase descending, so you see Phase 3 trials first, down to Phase 2, and then 1. The reason that we show them all that way is phase three isn't necessarily better. I'm sure those drugs or treatments are a little bit more validated but there are advantages to phase one trials, too. There's no control arm. Some patients prefer that. They want assured access to a new thing, even if it's a less proven thing. We don't have an opinion about what's better or worse so we show them all and give people a chance. Now, I started to answer the second half of your question, which is: What is Phase 1, 2, or 3? Phase 1 trials are where drugs or other therapies are first introduced and tested for safety. In the Phase 1 trial, people are trying to figure out what's the right dose, what's the safe dose, and they start getting an initial read of efficacy. However, the trials aren't designed for efficacy testing, they're designed for safety testing. Phase 2 is more efficacy based testing. It's a broader group of patients. It's expanding that dose to more people to see how it affects cancer. When they start getting some data in Phase 2 that indicates the drug is really working they go into what's called a registration trial. Phase 3 trials are where you're trying to get the drug FDA approved. Those are much bigger trials. It's much more defined patient cohorts, and the outcomes are much more statistically measured.
Laura Carfang: Thank you for defining all of that for us. We have some terminology to use and describe. One term you mentioned was the control arm. In these Phase 1 trials, if I am understanding it correctly, everyone who participates in that trial is a recipient of that drug or therapy, there is no placebo or alternative arm.
Martin Naley: That is true. But I want to temper that. In Phase 3, there's no placebo. It's the best standard of care and it's really important to know that. It would be unethical to put a cancer patient on something that you know won't help them. These trials are absolutely done for patients. They want to help patients while they're advancing these new treatments. That’s why I've always believed, and I learned this from a mentor, that research medicine is the best medicine because there's a chance you're going to get the new thing but even if you don't get the new thing, you're still going to get the best care. That’s why people who go on clinical trials live longer. There's great research out there that shows one year survival and five year survival statistically improves just by getting into a trial, not necessarily even getting the new new thing.
Laura Carfang: Understood. Thank you, I would like to welcome Abigail, Alyson and Sheila to the conversation. All three of you have amazing beautiful stories. All of you are living with metastatic breast cancer. You've come to it in different phases, which I think is really great. One of our Surviving Breast Cancer members started off being an ER positive breast cancer patient and then ended up with triple negative breast cancer. She was shocked to see that the subtypes can actually change and wanted to know if that was even possible. So I'm looking at you,
Alyson, who I know who has had that exact experience where you were diagnosed in around 2007, with ER positive breast cancer and had a phenomenal response to all of your therapies and then 10 years later had a recurrence where it came back, metastatic and also triple negative, correct?
Alyson: Yes. That is what happened to me. I was completely floored. I didn't know that could happen. It was extra upsetting at the time. It was bad enough. That's been my situation. I've been living with metastatic triple negative now for almost two and a half years. I've had my ups and downs. I think we all have. I've been on many lines of therapy. In fact, I lost count, I'd have to go back and see, probably five or six. I've been on some of the more novel therapies. I've been on the more traditional therapies. But overall, I'm doing pretty well. Luckily, nothing's in my organs. That's really lucky. I've had a hell of a time with my neck. I don't think I'll ever think of the expression “pain in the neck” in the same way. I don't think I'll ever call anyone that. That's been where my cancer likes to hang out and cause me trouble. As far as clinical trials, I personally haven't had the experience of participating in one, but, of course, I realize the importance and I've been in consideration for one. I went pretty far down the line. It was pretty much the same story Martin was alluding to where I was out to dinner with some friends and I thought I qualified and then I got the call saying I didn't. It was based on medical minutia even my doctor thought was minutia. But I'm hopeful that I will find opportunities in the future clinical trials.
Laura Carfang: I can see how that would be very challenging news to receive, let alone a diagnosis and a recurrence and thinking you're so close to being a beneficiary of being on a trial to realize that there's small little things that still can disqualify us. I'm sorry that you had to go through that experience. And I will circle back with you because I know you did have experiences trying to work through collecting all of your medical records and all of your data, which is such an important piece. But I also want to welcome Sheila who is joining us today as well. It's lovely to have you on our live stream. You have a wonderful story as well. And congratulations! I want to say thank you for your service of 25 years in the Air Force. That's incredible. You discovered your lump when you were in the Air Force, correct?
Sheila: Yes, I was active duty in the military back in 2009. Quick backstory: my mom died of metastatic breast cancer in 2004. Five years later, I got it. I was diagnosed metastatic. I sneezed and didn't know what it was. It was breast cancer that had spread to my liver and ribs. I've been living with it for 11 years.
Laura Carfang: 11 years. That's phenomenal. Can you tell me a little bit about the symptoms? How did you know?
Sheila: I thought it was like a weird feeling, it burned. I remember thinking, that's weird. I thought it was my breast. I had had my mammogram and had been getting mammograms since I was 37 because my mom died when I was 37. I sneezed again, like a week later, and I felt it again. I went to my military doctor, and I said every time I sneeze, it burns. So they did a mammogram. He brought me in, and he showed me, saying, “see that white stuff on your breast”, he said, “that's breast cancer, what you were feeling was the cancer pressing on to your ribs”. I'm 43 years old. Having fun enjoying life. Who would have thought 43
years old? I didn't even know black women could get breast cancer. You look at commercials, and back then you didn't see black women with breast cancer. The only person I knew was my mom. I had to retire from the military and take care of myself.
Laura Carfang: I appreciate you sharing your story too. I'd like to turn to Abigail now to share a little bit about her story. Every time I listen to it, or read about it, I'm always discovering something new. What I want to highlight about your story is that you were diagnosed with stage two breast cancer, and went through all of the typical treatments of surgery and chemotherapy, and within a short period of time discovered that it was metastatic and had spread to your bones. The unique piece about this is that although your lymph nodes came back, no negative, it actually traveled through the blood to your bones.
Abigail: It was incredibly shocking. It was actually a medical mistake, when I went for my first dose of chemo, the nurse checked the box to check my tumor markers. In the middle of chemo thinking I was stage 2 I found out that I had actually been stage 4 from the beginning and the tumors in my legs were actually substantially larger than the tumors in my breast had ever been. That was why I was limping and I was one bad step away from both of my femurs shattering. It was a huge shock and rushed into emergency surgery within days of discovering that I was stage four. Now I have lots of metal in my body, I have rods in both femurs. I’m still waiting for the superpowers from all the radiation, you know, there has to be some silver linings to all of this stuff.
Laura Carfang: One question that I want to follow up on is, we've been talking a lot about clinical trials and Martin gave us a great overview of matching and how to find them in this amazing report but I wanted to ask, and this is to anyone, how did you first decide that this data piece was really important, that we needed to have a centralized place for medical records, that you could feel empowered to then send it out to places, to medical fields, and to doctors, and then that you wanted to start investigating whether you got accepted onto a clinical trial or not, that clinical trials were something on the horizon for you?
Abigail: I could take the first piece. I moved in the middle of my treatment from one city to another. I physically gathered all of my records. I had four binders full of paper, and CDs. That's the way that I thought about things, and my background is, as a lawyer, so I would always have the paper and then 12 electronic backups because I was always losing things. I also knew that medical records are typically kept seven to 10 years and so having the physical pieces of paper made me feel comfortable that the records would always be accessible. It wasn't until I had done all of that work that I had found out about Ciitizen and the way that they gather the records for you, which would have saved me a whole lot of time running around trying to get information. That was a huge effort. I also came into this thinking that clinical trials were for people who are about to die. To me, it was a Hail Mary last ditch effort. When I came to my current medical oncologist I was about six months into my diagnosis, I signed up to participate in my first clinical trial, which was a method of genomic testing. It was testing on my original tumor to find out if there were actionable mutations, mutations that had a treatment specific for them. As a result of that trial, which was conducted at Memorial Sloan Kettering, I found out I had the PIK3CA Mutation, which has led to my second treatment, which I'm still on, which is Piqray.
I'm thankful I learned early on that clinical trials are not just about taking medicine. I'm sure Sheila will talk about her experiences of actually being on an experimental treatment that has worked wonders for her. But clinical trials are also about learning, just learning about how tests are run, or about a different technique. I'm actually in a clinical trial right now, that is looking at your blood work and circulating tumor DNA and the idea is to be able to give doctors a leading indicator, and they think they're going to be able to tell doctors a year to 18 months in advance, when cancer is progressing or mutating such that you're going to have a progression. So my experiences with clinical trials have all been about taking my data, taking my blood, taking my tissue, testing it and then giving me information about it, which is, I think it definitely was something that I had not thought of, in terms of participating in a clinical trial. That's been a great experience.
I'm going to get on my soapbox for a second as a lawyer, I'm always super interested in informed consent. I'm always super interested in the documents that people have to read. I'm always super interested in the Justice piece of the people who really need the trials getting access to the trials, but I have a nonprofit, and through my nonprofit, I recruit lawyers. One of the things I want to tell everybody who is listening, if you are getting into a clinical trial, and you don't understand the type of paperwork, if you don't understand the consent, I will find a lawyer in your area to help you interpret that document. Everybody needs to understand 100% what they're signing. I'm not saying that that means that anybody's doing anything nefarious, it's just that these documents are often written in language that us lawyers use, and it's a whole jargon all on its own, just like medical jargon. Don't make the documents, or not understanding what they are, be a barrier to participating in a trial, because I'm happy to help with that.
Laura Carfang: Wonderful, thank you. That was Connect4 legal services. To segue from there, Sheila, what was your experience with clinical trials? When did you know that you wanted to get involved?
Sheila: I had a fourth progression, on my sixth line of treatment. My doctor said it was progressing again. I said, well, what do you want to do? So she said, well, you can go back to a standard one that's already an approved treatment, or you can try this clinical trial. And I said sure. My platform is clinical trials and getting black women and men to participate in clinical trials. Considering the medical mysteries, our history, and our cultural difference, I said sure. I've been on it since July of 2018. Like Abigail was saying about informed consent, you have to make it something where I can understand it or, even in a black community, make it so the transportation or daycare is taken care of, make it easier for people to participate in clinical trials. When I was on Twitter, I saw somebody say, well I have to pay for parking. Why did I have to pay for parking? This should all be human centered to the point where you make it easier for people to participate in clinical trials. Don't make it harder. It's already hard enough. It wasn't a last resort. I just decided, if I'm gonna walk the walk, I’m going to talk the talk. That's when I decided to participate.
As far as medical records, in the military you get a stack of medical records when you retire. You don’t know what to do with all of it. Luckily, for my hospital, I joined Ciitizen. I was talking to Sophia and Ricky Farley, and said, why don't you try to get people involved in Ciitizen, so that all medical records are in one location. If I want to see my scan, I can see my scan. If I want to see anything from 10 years ago, I want to be able to just go on a computer and see it. I don't have to need all this paperwork. I think it's all about education. What people don't understand, too, is from the Tuskegee Study, the IRB was formed. There are so many guidelines now and protocols with clinical trials, we're protected from things like syphilis, and the Tuskegee Study.
Laura Carfang: Exactly. I'm going to turn to Martin now, and I'm going to bring him back on to join us in this conversation, because this is a great segue to actually linger a little bit more on exactly what you were saying, Sheila, about informed consent, some of the ethics around clinical trials, as well as the protections that the institutional review board is going under and all of that. So Martin, can you explain a little bit about what those best practices are to ensure the health and safety of people participating?
Martin Naley: I just want to pick up on something that was mentioned a moment ago about minority participation in clinical trials. I found some numbers just recently, I was working on a project and came across these. African Americans make up 12% of the US population, but only 5% of the clinical trial population, which is definitely an underrepresentation. Then you look at Hispanic population, and that's 16% of the United States, but only 1% of clinical trial participants. That tells you there's a lot of room for improvement. Overall, about 20 to 40% of patients could qualify for clinical trials, that's the estimate out there based on academic experts. I've actually found trials for just about every person who's come through our service, so it's probably higher than that 20 to 40%, but only 8% participate today.Then you look among ethnic subpopulations, and white people just have a much better chance of participating in research than anybody else. Any solution that comes to bear for clinical trial matching has to address that inequity, or it's not a solution. That's our point of view. Just wanted to get that out there.
Regarding protections, I think a lot of the protections exist today because of what was mentioned here about Tuskegee, and so on. There were poor protections in the past, and exploitation of different groups of people to do research and that is unconscionable. That’s why these protections do exist. Every clinical trial is overseen by an Investigational Review Board, which is part of a medical institution. Every institution has one. Also, there are investigational review boards that span multiple institutions so that community hospitals can also offer research without having to develop their own IRBs. These IRBs meet and talk about a protocol and they won't allow that protocol to happen at an institution unless safeguards are in place. Those safeguards are described in an informed consent document that's given to the patient. Like Abigail said, those can be really dense. It’s important to get help and to read through them. I do believe they're written with the best intention to protect the patients who participate in research.
Abigail: I would agree with that. As a lawyer, I've drafted lots of documents where I understood what they said, but the lay person would not. I wasn't casting aspersions on anybody's intentions, they're just that us lawyers do speak in a different language. It’s important to know that, and it's important to know as a patient walking into it that nobody's trying to hide the ball. Nobody's trying to confuse you or make it more difficult. It's legitimately that everyday words that people use, oftentimes have a different definition in the legal context. Also, everyday words often have a different definition in the medical context. It legitimately is you're just walking into somebody else's world in terms of language.
Sheila: We had this discussion on Twitter the other day, where it said, Are you looking at me as a subject or a patient? Do I look like a subject? No, I don't look like a subject. I look like a patient. Don't call me a subject. That's another thing, a cultural difference. experimental drug. We're already thinking that we’re being used as guinea pigs. We’re patients and patients matter.
Alyson: Right, I wanted to jump in and talk about my experience when I came very close to being in a clinical trial. I mentioned earlier that I thought I was going to enroll, but I didn't. I wanted to sort of recount what it was like to go and learn about the trial. I went to the office of the trial coordinator and there were a couple of nurses who focused on trials who were walking me through the study design. It was very complicated. I have a PhD, not in science but in literature, and I've worked in the pharmaceutical industry for 15 years and I had difficulty understanding what they were talking about with the study design. My husband looked at me, a Yale graduate, and he whispered in my ear, What the hell is a wild type? There's a long way to go with trials, even with just writing trials in a way that makes sense to people. I could have easily run the other way. There were no handouts about what the trial was or about what the terminology meant. They gave me a copy of the study design that the scientists used. Frankly, it was appalling, the way information is communicated to patients. Something I really feel passionate about is bringing that to light for a few reasons. One, if you're in that situation, and you're considering a trial, and you have no idea what they're talking about, just realize you're not alone, as most patients don't have any idea. You guys need to do a better job of taking things down and explaining them. It’s a big piece of why people don’t enroll. People don’t know what a wild type is.
Martin Naley: Right, and nowhere in your medical record will it ever say that you're wild type. It would be the absence of information, you just wouldn't have a mutation in that gene reported. That's what makes it impossible. These patients and trials are desperate for each other and yet, they're just ships in the night. The trials are out there, saying, come on down if you're a wild type, and nobody knows.
Laura Carfang: It seems like we could do a lot to bring the groups together, which is what we're working on doing. It's all of these constituents. It may even be part of the IRB process or the recruitment process of meeting with the patients and saying, does this actually make sense? It’s saying, I'm the primary investigator, but what questions do you have that we could have this handout or this FAQ sheet that we give to people in advance and really start moving the needle that way? We talked a lot about your experience collecting the data piece, and then participating in the long arduous process of becoming clinical trials. Martin, it sounds like what you're doing at Ciitizen is really trying to alleviate some of these pain points. Can you talk a little bit about what your process is like for collecting the medical records and then matching and what can a patient expect when they reach out to Ciitizen to get more information and get involved?
Martin Naley: It's all designed to be a 60 second process. It's all online. You go to the Ciitizen website and sign up, you can do it on your phone. You take a picture of your driver's license, and then Ciitizen uses your signup form with your ID to go to every place that you've had medical care, and make that request on your behalf. It's your legal right to get your data. Ciitizen helps you exercise that right, which is afforded to you, under HIPAA. A lot of people talk about HIPAA as kind of a blocker in healthcare. It's actually not intended to do that at all. The P in HIPAA is not privacy, its portability. The idea is to make your data available to you where you want it. We go ahead and make those requests. Institutions typically deliver those medical records to us in giant PDF documents, just like what you talked about Sheila, that 1000 page binder of your medical records. I've worked with a lot of companies who have tried to argue that data should be more interoperable and try to fight the system. One of the things we realized at Ciitizen is that it wasn't worth it. You're not going to change the system everywhere. There's a lot of incumbency, in health care. We said, fine, give us those 1000 page PDFs, we'll learn how to read them.
What we did was make a machine learning process. Machine learning is a fancy language, but basically what it means is you start a machine, and the machine is wrong all the time. You start feeding documents into the machine, and you just start telling it that it's wrong. Every now and then the machine makes a lucky guess and you verify that that lucky guess was right. Now the machine has learned, when I see this, I want to get that from the document. What Ciitizen has done is made it possible to take that 1000 page PDF, and pull out the information that's important for your cancer care. The machine has gotten to a very high accuracy point where it's almost always right. There's a small team of clinical reviewers who look at the machine outputs. They do the verifying to make sure it keeps on learning, and then also tell the machine when it's getting something wrong. Those things get published as patient cancer cards.
As a patient, you start out with the 60 second onboarding process. A couple weeks later, sometimes a couple of days later, sometimes within minutes, you get a digested cancer card of your cancer story from the beginning from all the places that you've had care. From there, you can start using it in different ways. One of the ways is to raise your hand and say I want to try. Then things come my way and we use an algorithm to figure out which trials might be suitable for you. The patient is completely hands off. That's all there is to it.
Abigail: And it's free, and doesn't cost the patient anything. If you as a patient are getting your records, the different hospitals are allowed to charge you, they're allowed to charge you a search fee. They're allowed to charge you, per page, even if they're emailing you the records. Here in Florida, they are allowed to charge $1 per page up to a certain amount, and then 25 cents a page thereafter. If you go through Ciitizen, you don't have to pay any of those things.
Laura Carfang: I know we're talking about metastatic breast cancer, but can early stages also participate? Or do they have to wait until they're done with active treatment?
Martin Naley: I think it's really important to mention that because we can always do an update. If you finish a round of therapy or have a new progression or a new status update, it's a lot easier to do a refresh than it is to start from the beginning in building those cancer cards. We encourage people to sign up, to get everything in place, and then doing updates is not a big deal. The other thing that's important to mention is we're talking about informed consent, and there's this notion at Ciitizen of a patient's full informed consent, meaning that a patient is receiving their records into Ciitizen, but every use of those records is authorized by the patient. If you're signing up to look for clinical trials, you agree to participate in that process. If your information is going to a second opinion provider, you're authorizing that. Everything that happens with your data is your choice. That's really important.
Alyson: I felt very comfortable with the whole process. I didn't initially answer the question of how I got involved with it. To be honest, I wasn't really looking for anything. I just met these guys, because they really got involved in the breast cancer community. I realized that, wow, this would be great if I needed a second opinion. At one point, I actually did need a second opinion and it was very stressful to gather all the records. I could barely get the records in time for the appointment. It would have been great to have some of what I initially didn't. Now I have a full report on it. I have to admit I haven’t really read yet, because I'm not really at the point yet where I need a trial but it was really comforting to see the sheer volume. You always feel like oh, I don't have very many but I was so overwhelmed by both the number and the range of types of trials. It made me feel really good to know you have so many options.
Martin Naley: Thank you. It's important to note also that some people do see 50 or more clinical trials in their report. Just for context, we have over 700 that are fully described in our database right now. We're working hard to cut those down for people. Out of those 50 or 100, we always try hard to get to the five or so that are within your location preferences and that are full match.The first few times I delivered those reports to people and they saw 50 they freaked out and I needed to figure out how to give them some markers in the road. We don't recommend anything. I'd say we're not medical professionals. It's not something we would do, but we want to make sure that there are landmarks to help people navigate these reports.
Laura Carfang: As we wrap up today's conversation, I would love to go around and ask each of you what piece of advice would you leave our listeners with today with regards to clinical trials?
Alyson: I would say definitely sign up for Ciitizen, you have nothing to lose. It’s good planning for the future. You might want to have a second opinion or you might want to enroll in a trial. Why not? It's free. The other thing I'll say is for people with triple negative breast cancer, which is what I have, there's still so much to be discovered. It's really a challenging cancer to treat but there's so much out there in clinical trials. Life extends possibilities exist out there. I think it's important for everybody, but especially if you have triple negative. Please pay attention.
Abigail: I think, other than signing up for Ciitizen, because you know, that's the obvious takeaway in terms of having everything in one place, I think the big piece of advice that I would give to everybody even starting out is to have this conversation with your doctor regularly. Even if you're doing amazing on whatever line of treatment that you're on, asking your doctor, is there anything else that I could participate in, such as the genomic trial that I was able to participate in that led me to my second line of treatment. Continually talk about that, not just with your doctor, but with your friends, I think that for those of us in the MBC community, we are talking to each other regularly, and knowing other people's experiences or being able to participate in a trial, at say, an institution that might not be local to you, will only result in being able to hear about different options, at least to continue the conversation.
Sheila: Like Abigail was saying, just continue to have open conversations with your doctor about clinical trials, about your health. This is your body. This is you. There's no right or wrong question. Continue to ask questions and ask your doctor about Ciitizen. What do you think? Have you heard of IT? What do you think about clinical trial matching ? I tell my doctor everything. Just continue to have those open conversations. This is your body. This is your life. This is important. We want to live. We want trials. This is top notch research. This is excellent research that, like I said, I've been on for two and a half years, and it's working well. I want that to work for everybody.
Laura Carfang: Martin, I feel like we just scratched the surface, one hour deep dive into clinical trials, how to get involved with Ciitizen, and where to go from here. I'll definitely be picking your brain later so we can continue the conversation. If there's one piece of advice, or anything you want to stress to leave our listeners with today, what would it be?
Martin Naley: A diagnosis of cancer is so terrifying and so overwhelming. One of the things that I'm so impressed about is the community that exists for patients with cancer, like people on this call today. Even people who aren't feeling well are doing everything they can to help other people because they know that they're not feeling well. I'm moved by that. When you're diagnosed with cancer, you're thrown in the deep end. Everything is really foreign to you. Even if you're an English speaker and you are well educated, in the most fortunate circumstances, it can still be overwhelming and almost impossible to understand. We're here to help. That's all. We want to make sure that when you hit those moments where you say I don't know what to do, or I don't know what this means that you know you can reach out. If you go through Ciitizens' process and you get a match report from us, you can talk to me personally, I'm here to help. Everybody who is diagnosed with cancer needs a hand sometimes. That's what we're here for.
Laura Carfang: Thank you everyone for participating, sharing your stories, providing us with just a wealth of information and the tools we need to figure out how to collect and take ownership of our medical data, and also how to find these amazing matching services so we can actually advance research, not only benefiting ourselves, but future generations. I also feel like there's a lot of topics we haven't yet talked about with regards to clinical trials. This was just a crash course 101, but we will be hosting part two. I believe some of the questions that we want to address are around financial toxicity. If you're participating in a trial, if you have children, who's watching them during daycare? Who is paying for the cost to travel to and from the clinical trial site? These are some real concerns that need to be taken into consideration. As we heard earlier in the conversation today, Martin brought up some great points about the percentages of people participating in clinical trials and we need to do better, we need to be more inclusive, and create a more diverse environment in these clinical trials so that we can have the data and the knowledge and the research so that we know that when we do prescribe chemotherapies or various drugs, understanding breast cancer further, how it affects different populations. This is really important, so stay tuned for part two.
If you sign up for Ciitizen, be sure to mention you hear about them from Surviving Breast Cancer (SBC). It would mean a lot to the SBC team!
