In this week’s episode, Aaron and Brittany are joined by Anne Marie Mercurio who is a Patient Research Advocate working primarily in oncology. They discuss the struggles of caregiving in the COVID-19 pandemic, listening to the patient experience and re-designing clinical trial protocol to fit patient needs.
Transcript
Brittany
Hello everyone. And welcome back to the Trial By Fire a podcast where we hear real stories from patients who have had a less than stellar clinical trial experience and discuss what needs to change. I'm Brittany, the ambassador manager for Clara Health, and I'm joined here with Aaron. I'll let him introduce himself.
Aaron
Hi, I'm Aaron. I'm head of innovation here at Clara. Basically all that means is I'm a plumber making sure that the platform that we have fits in with the needs of our partners. But less about me, more about our guest. So if you want to quickly introduce yourself.
Anne-Marie
I am Anne-Marie Mercurio. I am first of all, delighted to be here with you guys today. I am a long-term survivor of breast cancer treated in 2006, 2007. And most recently my challenges were as caregiver to my mom who was diagnosed with two early-stage primaries and then her disease metastasized. And she was living with primarily stable disease until, I want to say May of 2020, and she sadly passed away about a year ago. So, lots to say about things that have gone on during that journey within the context of dealing with COVID at the same time. So happy day, happy to be here.
Aaron
Yeah. And thanks so much for making the time.
Brittany
I'd love to hear about your clinical trial experience. I understand that it was with your mother. So I'd love to hear a little bit more about how you heard about the study and kind of walk us through that journey and what happened.
Anne-Marie
So if I may, I'm going to back up to 2007 and let you know that in 2007, when my reconstructive surgery was getting done, I did not realize that I was, I was enrolling in a clinical study for the implants that are now banned worldwide. I pulled out paperwork and realized that it was an informed consent document that I was signing. I was in there for my pre-op appointment and I thought I was signing surgical consents. That was quite an eye-opening experience for me to see, back in 2007, when I signed those papers, it looked like a car lease. It was similar to when I was replacing my car a year and a half ago: initial here, initial here, initial here, sign here, initial here.
And I was alone in the room, with the nurse. And at no point in time, did the words clinical trial or clinical study or whatever it was come out of her mouth. So, that was my kind of first, first steps into the whole clinical trial space. Now most recently, with what was going on with my mom, treat as is typical with metastatic disease. Treatment works for typically the first treatment will work for a longer period of time. And then as you start moving down, each success of treatment tends to work less than the one prior. So she was basically out of what I would call acceptable treatment options and the doctor offered her a clinical trial. And I mean, I'm not gonna go back and, and talk about the, how difficult it was for this to even happen in the context of phone calls from his office to her, and then from her to me and this whole triangle of bad communication, which I can't really place the blame on anyone.
This was May of 2021, New York was an utter mess. So everyone was kind of trying to figure things out. So, I cut them slack for that, but I guess it must've been like September, we finally, or the end of August. So probably about a year ago, we were in his, we, I got an exemption from the institution to be able to accompany her to the doctor, the doctor's visit. And he presented her with a trial. And first of all, I will say the document looked far different. It wasn't like little tiny words that you could barely read. It was a lot of white space on the paper. He explained the trial very well to her. However, I did take exception when he made the, the reference to this exciting new treatment, as opposed to standard of care, because we don't know if it's an exciting new treatment or not until the trial is fully accrued until all the information is turned over to the data people so that they can analyze this, the statistics behind it to see if this is indeed better than standard of care, worse than standard of care.
So it got pitched for lack of a better word as this exciting new compound. And I just, I was truly walking this razor fine line between trying to not take hope away from my mother and, and not wanting to like lunge because of all of the work that I'm involved in, in the advocacy world with clinical trials and ha having a full understanding that until the data is in and analyzed, we don't know what's, what's better. What's, what's not better. So he, and then ultimately what wound up happening after we went through the whole meeting and she signed the consent forms and she, we were driving home and she's all super excited about the prospect of being in this clinical trial. And I'm trying to like, keep this poker face on to say, mom, this is how we advance the science.
So I'm like, I can't have this conversation with her. I have to, I have to take off my advocate hat and stay very much in daughter mode here and just support her as a daughter supporting a mom. A day later, the oncologist called me to let me know she's not eligible for the trial and why, because of the way they were going to be measuring progression of disease. And I was so irritated because the same people that identified her as a potential candidate for the trial had full access to all of her medical records and the same way that I could look at them in her portal, they could pull up the scan that was done literally weeks before. And see, it's not one giant mass of metastatic disease. There are five or six, and we're going to have to be looking at five or six different sites to try to measure progression because it was a multi-site metastasis.
She was deemed ineligible. He couldn't get in touch with her. So he called me and I had the wonderful pleasure of having to call my mother who was all gung ho about participating in the trial and tell her you're not eligible. And that was heartbreaking. It was heartbreaking for me, even though if I'm going to be totally truthful, I wanted her to transition out of these toxic treatments and onto comfort care because she was 82 years old at the time. And I just felt like you're beating your body up at this point. And, and it's, it's, there comes a point where your metabolism is slowed down. You're feeling okay. Let's just, let's just worry about keeping you comfortable and let things, let's just see how this all works out. But yeah, I had the wonderful pleasure of having to tell her, you're not, this was after talking her off the ledge about, well, what if I get the placebo or yeah, I said, you're not, you're, you're going, you're, it was an open-label situation.
So it was, and, and the way, the way the trial was randomized, it was, two to one. So two people would be getting whatever they were studying. And for every two, one person would be getting a physician's choice standard of care. I said, the worst that's going to happen is you're going to end up with whatever he was going to treat you with anyway. So after we got rid of that, that hour-long conversation talking her off the ledge with this, here it is here, a day later, I'm like, well, that was a wasted conversation because now I have to tell her she can't be, she, even though she consented, she's not eligible for this study. And frankly, that irritated me because I think that when you approach someone for, for a study from the site side, as much information as you have about that person, that's going to be potentially consenting.
You should be looking at before you approach the person. It shouldn't be that the person that's trying to have hope in their heart, that they're going to be on the cutting edge of something new and wonderful is now excluded over something as silly as the way you're going to be measuring disease. She was getting scanned so frequently anyway, because that was the only way that her, her, the blood markers that they used were never reliable in her case. So she was going through scans every three months anyway. So you have seven years’ worth of scans that you can look at and pick the pieces that you want to measure. But as is the case with every protocol, there are no deviations, but I would think if there was a patient involved in designing that protocol, they would have pushed back on that eligibility criteria. They would have said, what's the big deal? So it's bone, there is, there are a couple of lesions on the bone, pick three and say, these are the ones we're gonna look at, and see how well this treatment seems to be working. So that's my, that's the whole ball of wax with what, what went on with my mom, with the clinical trials. So.
Aaron
Oh, gosh. Well, I'm so sorry to hear that. It's funny. I'm hearing two things that were happening and one of them ties your mother's experience and your experience together. And it's like this weird communication flow where things were not considered all the way through in terms of patient experience. It's like, well, technically we gave her the paperwork in your case, like we gave her the paper, she signed them. I don't know. And then in your mother's case, trying to be nice about it and then not having done the legwork and looking at the thing, but the second thing there, that we should dig into both of these. But the second thing I'm really curious to talk about is that protocol design piece that you called out, because this is something that we see in the industry. This is something that we've helped, some of our partner trials through.
And we just kind of see all over the place where the protocol itself becomes so strange and rigid. And like you were just saying, it's not like there was a lack of cancer to be tracking within the body. So what was the actual issue? The issue was, well, somewhere along the line, 17 months ago, someone wrote something into a piece of paper, it cleared IRB. And now here we are excluding folks who could probably qualify against that criteria.
Anne-Marie
I have the privilege and the honor of working on clinical trials and working on the design of protocols. I feel very fortunate when I'm invited to the table to review informed consent documents and make sure that they're easily understood. It seems that happens more in academia than it does in industry trials. I think that we're still, like NCI has, has pushed with teen science and making sure patient advocates are embedded into steering committees and, working with PIs (Principal Investigators) and we're, they're required to have patient advocates on their teams when they're submitting for NCI or NIH funding within certain many mechanisms at this point. Now where the industry is still, I don't think sees that there is value.
Like I know when to shut my mouth at a, at a, if I'm sitting at a table with a bunch of researchers, there are times when I will sit like that. They may look at me like she's got nothing to add. And it's like, no, I have nothing to add at this moment in time when you get to things that are going to be very practical and, and very much patient-facing, I will put my 2 cents in. I'm just not going to interrupt your scientific discussion because that's not where I add value. I add value when you're telling me we need to bring this person into the clinic, once a week for blood draws, and I'm going to push back and say, why is there a reason you need weekly blood draws? And if there is a scientific reason and not just because you want the extra blood for banking, for future use, for future studies, but you need it once a week.
Well, then I'm going to say, what about the mom or dad who's caring for kids and has to throw two kids in a car and drive for an hour to, to, for you to get a phlebotomist. Can't you send a phlebotomist to their home? There are, there are so many ways to make this, and that's where I pushed back on, on. And I don't, and it's not pushing back in an, in a negative way. It's just like, wait a minute. Let's think about this. And because at the end of the day, we all want the same thing. Let's accrue this trial as quickly as possible. Let's put the evidence together, let's see if we have something here. That's that, that, that that can advance the science, advance the treatment for patients everywhere and, and, and move the field forward. The faster we can accrue.
Well, the, the, the way to make that happen is make it as easy as possible for anybody that's potentially eligible to join the trial. And then that leads to the whole eligibility criteria conversation, which I think we already had. So I'm not going to go back there. I've had the opportunity to lend my voice. I'm very outspoken in certain places. And then, when I'm at a table where the right thing for me to do is to just sit and make notes and wait until the right moment to say, have you considered doing something in this fashion? It might make it easier for reducing the patient burden and, getting a larger audience, improving the diversity of the trial, because you're not making it difficult for people that may have to use public transportation. There are just a million different ways that my mind just like blows up. And I'm like, ah, I think we can do better here. And I'm always looking for the, where can we do better? And is it feasible to fit into the protocol?
Aaron
No, that's absolutely awesome. And I'm glad that someone like you is at the table. Did it take a while to get yourself to the table? Were there ever any hurdles that you had to clear to even prove you’re bona fide enough to get to the table?
Anne-Marie
Absolutely yes. It was a process of, I think there should be like kind of training programs for how to be an effective research advocate. We all have our strengths and our weaknesses. For many years, the place I felt that I was being most useful was helping newly diagnosed patients navigate through asking the questions. But the truth of the matter is that it’s a very emotionally draining thing and simultaneously doing all of this. I was going to the scientific meetings. I was meeting researchers and some of them were gracious enough to invite me to participate with them on grants that they were submitting. That kind of launched me then and I took that very seriously.
Even at that point, they don't have funding. Without funding, there's no way that I'm getting any sort of payment for this, but it was like, I'm passionate about this stuff. So if they're applying for funding, I'm going to help them make this protocol as strong as they can so that they can submit it. And I'm going to write a letter of support. To establish yourself with credibility, you have to follow through on what you promise somebody that you're going to do. When they see that you're going to step up and you're going to do what you say within the timeframe that you promise. I think that that has given me more credibility than other people. I know their interests. I have PIs that'll introduce me to another PI in their institution, and then it's a multi-institutional thing that's going on.
And if I can't do it, I'll say I want to, but have too much on my plate. You might want to try contacting this person, because I don't want to lose my credibility with the research community. I want them to know that if they ask me to do something and I say, I'm going to do it, that I am going to get them whatever they need within whatever timeframe they've asked or I've committed to. And I think that that's, I've been fortunate, like I said, with initial invitations and, initially sitting on grant review panels and meeting researchers that way. And I can say that I've had people contact me a year or two after being on a panel together saying, “hey, remember we were on that panel together. I'm submitting a grant. Would you mind reviewing what I want to submit and tell me what you think? If you think it's something that you would be interested in working with me on, maybe you can break it down, write me a letter of support.” So it's all about building relationships. And sometimes they come at you in the strangest places, or, like I said, that one email sticks in my head because it was like two years after the fact. I'm like, my goodness. I remember this conversation I had with this researcher. And it was, after the review meeting, we bumped into each other in the elevator and we were talking about something. And he said, until you pointed whatever it was out in that room, I had never heard a patient explain that to me.
My only communication as a researcher was with the doctor and the doctor wasn't. So there was a communication breakdown. Patient is saying something to the doctor, the doctor is not saying it to the researcher. So now he, like the doctor, got cut out of the conversation and here he and I are sitting there and I'm like, yeah, that drug is not as well tolerated as you might think it is. It was like a mind-blowing experience for the both of us. I'm like, how could you not know that? And he's like, how could the doctors not have been telling me this? So it's those kinds of relationships that, that have kind of, I feel like I'm sitting in a place of, of very, we're, I'm very privileged to have a group of researchers that have come to trust me and invite me to participate when they're drawing up proposals or protocols. So does that answer your question?
Aaron
Yeah, no, definitely it did. And I want to kick this over to Brittany and just a sec, but, me being me, I should, I want to say what I want to say first. It's funny that you mentioned, to establish credibility, you gotta say what you're going to do and deliver it on time. And it's funny because it does go both ways where I don't think that's always like the case when we turn the relationships back backwards and we say, okay, well, what about industry to patient, academia to patient? It's not necessarily that they're doing a great job of increasing their credibility within the communities, but I am glad that someone's thinking about it from the patient perspective. Anyway, Brittany, that aside, we'd love to kick it over to you because that's exactly what we've been kind of working on with breakthrough crew members to get them ready to interface with the industry, right?
Brittany
Yeah, absolutely. We've been talking with a lot of people about specific protocols and kind of highlighting that theme of how much the patient voice isn't included and some similar stories that the way that clinical trials have been marketed to them, as this is going to be, life-changing, revolutionary, particularly in the Huntington’s Disease (HD) space. And as we know that trial did not go through and it was heartbreaking for many.
Aaron
Yeah. And just to back up, that was a, we were running a focus group to sort of review protocol and hopes and fears of the HD community, with a partner that was about to launch a trial, and then everything got canceled and they went back to preclinical and it was kind of a mess and kind of came, down really, really suddenly. And I know that a lot of patients were quite heartbroken about that. And again, going back to that idea of credibility, just that suddenness of the communication and the firmness of the communication and just like, okay, well, good luck we'll see you in five years, hang in there, was not exactly a great look for industry.
Anne-Marie
Okay. So you touched on something that I have personal and intimate knowledge of with the trial you just spoke of. An extended family member that was involved in one of those abruptly shut down trials. Right. Without slamming anyone, because that's certainly not what I ever want to do. What might have been a more effective way to handle that[ is to say] let's find some common ground here and let's, one thread and I have one thread, and that's all we have in common, but let's, let's work to build on that to make a better experience for both sides, because let's face it, everyone, everyone has something invested here.
I mean, on the, on the industry side, it's money, it's manpower, but on the patient side, it's someone's life, it's someone's mother, it's someone's spouse, it's someone's sibling. In particular with Huntington's disease. I think if I'm not mistaken, it was two trials that came crashing down simultaneously. The way that was communicated to the participants in those trials was less than optimal. I watched a couple of the webinars, and frankly, it was very upsetting because I'm looking saying you guys are supposed to be representative of the patient population. And it sounds like you're, all you're doing is pushing the industry message that these people already know. And, and, and these are, that's a desk, anyone with, within a rare disease space, those are desperate populations for any sort of treatment. So, all right. I went off on a complete tangent there with nothing to do with anything to do with cancer and any, anything, but I did have firsthand knowledge of that. I got looped into what can be done next and used my contacts within the oncology space to help guide someone as to what their next step should be.
Brittany
Absolutely. And speaking about what comes next and hopeful things, I'd love to kind of talk about the landscape of bringing the patient voice into these clinical trial protocol designs. just advising in general, how have you seen that change and evolve over time, and where would you ultimately like to see that go?
Anne-Marie
So, when I first started doing this, it was, it was less about, I was invited into the lab if the grant got funded and I got to speak with all the lab members where, now I understand, I don't understand the science on any level, anything near a science, what a scientist would understand, but I understand enough to be able to sit down and listen intelligently and ask good questions. I think that, now we're getting to the point where the PIs are starting to realize if it's, if we're not asking questions that are meaningful to the population, we're trying to help to get answers for, if these questions aren't scientifically important, but aren't going to advance at the end of the day, the either life expectancy or improve quality of life or something, that's going to be meaningful to a patient.
Then that's where I think I get to add value. Like I get to push back on, are we doing this? And I can sit there and get as fascinated with any sciences going down this science rabbit hole. Hey, that would be really cool. And maybe we could figure this out. Maybe we could figure that out. And then it's like, wait a minute, wait a minute. Wait, let's remember. At the end of the day, we're looking at a piece of tissue that ultimately came out of someone's body and we're trying to identify something. And I think now there's far more give and take more so with academia than I see with industry. There are some industry partners that are bringing patients in, but I feel like we're being brought in a little too late. Don't bring me in after you've already developed the protocol and you have the informed consent in place and you're trying to accrue.
So you want me to help you with patient-facing materials. Too late. I should have been here even if I didn't have, even if I didn't have anything to add, but just to kind of like, and I understand there's confidentiality issues and all of that other stuff, but you know what I am and well aware of my role and what I can and can't say and what I can and can't share. I take that very seriously. There are projects that I'm working on that I can't, I can't talk about. I signed a confidentiality agreement that I'm working with, such and such a lab on such and such a project. And frankly, until that trial is opened, it's none of anybody's business. And I, unless it's someone that's on the team with me. So I get it that there's, there's a leeriness of, how do we, how do we make sure that the integrity of the trial as we're moving through to open it up and, and make it public, that this is what we're doing is not, there's not going to be a leak along the way somewhere.
I want to put it out there that there are those of us that are serious about this, or equally serious about the integrity, our own integrity and what we're bringing to the table to make sure that we’re not breaking any state secrets here. And we're making sure that we maintain the strictest levels of confidentiality.
I work as a paid consultant for a couple of different places. And I just had a conversation with people yesterday about putting something out on a social channel. I'm like, I need a financial disclosure form because I want people to know, I sit down with you folks once or twice a month, and I'm being paid for that. And I don't want to be seen as somebody that's putting some so same thing goes with anything that I would be doing for an industry partner or within academia.
I mean, I want my full financial disclosures out there so that everybody knows if I'm saying something it's because I believe it not because someone's paying me to say something. And I think that there's, there is a little too much of that. And there, I mean, I can point to certain social media platforms where it's obvious that someone is just being paid to try to push something out there. And I hope I never come across like that because I think that weekends, weekends, the whole movement of how to, how to bring the patient voice to the table in a way that's going to be most impactful for everyone that's at that table. Most especially, the people that are trying to develop a drug and then the people that they're trying to help. And, and everyone else at the table gets a say, whether it's the payers, whether it's the providers, we, everyone needs to know that they have an equal kind of an equal footing in the, in a seat at that table.
Aaron
Amen. I mean, it's also, it's also the relationships themselves are so limited at the moment, right? Hopefully, we get more and more patient engagement over time. That's more and more authentic, but right now we're in this strange place where it's trying to happen. And then there are some bad actors or implementations maybe that are just done poorly, it's hours, everyone's mood, and then there's a lack of trust. And then that rolls over into the next thing and the next thing. And all of a sudden, you're being asked to review a brochure that doesn't make sense to anybody, probably including the researchers, because it had to get dumbed down somewhere and we're like watered-down somewhere, excuse me. And now everyone's on.
Anne-Marie
You use the right words. It's, it's definitely the, the dumbing down, because sometimes I'm dumbing things down for myself. I mean, I sit there with something I'm like, I have no idea what I'm reading. Let me put this on like a, basically second-grade level so that I can grasp what I'm trying to do here. but I do think that look, there are people that have had poor experiences with having advocates at the table. And unfortunately, that sets all of us that are trying to, to make a difference in a way that's, as professional as we can be understanding what our shortcomings are and that, the most important thing that I bring to a table is to be able to say, I don't know what I don't know. And I'm not afraid to say, I don't know what the answer to that is.
I'm only looking at this from how a researcher once to told me many years ago, everyone that's involved in the project has to have a buy-in and I never forgot that.
I'm like, you know, what? So now it's every project that I approach. I'm like, okay, who else is involved in this thing? And what is each person's buy-in because if everyone doesn't have a buy-in of sorts, then ultimately the project is doomed to fail because there's so many places along the chain where one weak link is going to make the whole thing fall apart. And I never want to see that happen. So I charted like, let me go. If I use the analogy of a table, let me go and try to sit in that guy's chair. And let me go sit in that girl's chair. And let me try to look at it from this perspective, so that when I'm opening my mouth to say, this is what I'm seeing from the patient perspective, I'm aware of the fact that it's not, I mean, I would argue, yes, of course, it is all about the patient, but we also need to be very cognizant of the, of the fact that there are everyone else in that table has a vested interest in, in this from one, one angle or another.
And at the end of the day, yes, we're trying to make, change lives, make lives better, advance the science, cure disease. We all waltz off into the sunset, living happily ever after in a, in a perfect world where, there is no more anything, but to get there, we need to be working together. And we need to know that everyone has their, everyone has their perspective. God almighty, if we're not seeing that in this world right now, with the polarization on every single level… It's just not helpful, especially not in a research space. You really need to understand what your role is, but also understand where everyone else fits into. It's like the pieces of a puzzle, throw them on the table, let's see how everyone fits together so that we can make this beautiful mosaic and advance the science and make it work. So.
Aaron
Couldn't have said it better. I want to kind of circle back and Brittany, please feel free to interrupt me if I'm just asking way too many questions here. I want to circle back to the communication issues that were happening with maybe even specifically just your ICF experience. We're just talking to someone the other day who put it in a way that I never heard it before, but I love it. And she was saying that it's the trial's first chance to make a positive impression. It's like their first impression of the thing will be this ICF form. And he was talking about how poor his experience was and how there was something hidden in there that said that there would be a biopsy on the left buttock and that no one had told him. I'm wondering, when you go back to that moment, maybe just walk us through what you were feeling as you were handed this thing, and they're telling you initial here and sign there. What was going through your mind? Because you would have been pretty early… well maybe not even started on your advocacy career. Right?
Anne-Marie
I absolutely was not. Or I think I probably would've realized I was signing an informed consent and not signing a surgical consent. I think that studies have been done and particularly in, in the oncology space where it's somebody that I know that was the lead researcher or one of the lead scientists on this study publication about when offering a clinical trial, most patients, including minorities, which are historically underrepresented in these clinical trials would participate. After doing this crazy analysis, what they came up with was there's a breakdown. there needs to be a personal connection. So it can't be about the piece of paper. It's about the person on the site side, that's approaching the patient, that's coming into the clinic.
So there needs to be trial champions at every, at every site where, where, a clinical trial is, is being, is being accrued to. So that there's a point person that is able to have the ability to kind of read a person's body language. not everybody bounces into the clinic in a great mood. Some days you come in in a great mood, some days you come in and you're just feeling really beaten up and knows how to approach the patient, because the document is the most important piece of, the, having the signature on that document is for everyone's protection. Most importantly, the person that's participating to make sure that they know what they are signing on to, but to have someone sit there and walk you through that line by line, by line and say, and, and even before the document comes out to say, look, these are the, the high-level things that are going to be required of you to your point.
We are going to need a biopsy. And if that's a, if that's a deal-breaker for you, then, tell me why, and maybe we can work through it. Or the person has the option of saying it's a complete deal-breaker. I don't even want to discuss it. And that's really the end of the story because at the end of the day, it's on the patients I have to consent to whatever is, we know, whatever additional testing is going to be required to participate in that trial. So I would say it's not about that. It is about the document, but before we get to the document, it's about the communication that takes place to make sure that there's some sort of educational material, just like they do when they, when, when you start chemo, they have a quote chemo teach lesson. So that before you start your chemotherapy, that you're sitting down and you're, what you should expect or could expect or might expect.
Same thing when you're getting approached for a clinical trial, it shouldn't be somebody. I mean, I had an experience not so long ago where somebody literally jumped out from behind the wall with a clipboard in her hand because they wanted me to participate in a registry study. And this was, this was, this was about, I want to say, yeah, it was like February 2020. So it was like, right before we were locked down, I was at a post-op appointment and she came around the bend and in my face with a clipboard. And I just, I'm pretty sure I rolled my eyes. I'm guessing here because I knew what she was doing, clipboard pen, it I knew I, and she's like, I just want to know if you would be interested. I said, give me the clipboard.
And I took it and I read what it was all about. And I just signed it. I said, here, when do I need to come back for my follow-up? No discussion whatsoever. However, this is me 15 years into this thing. And probably 10 years into advocacy, another person that got approached like that: a) would have jumped out of their skin because she really did jump from like, behind a wall or behind like a, a pillar that was in the, in the kind of, in the waiting area, wherever it was. so I really think it's key that patients are approached in a, in a somewhat, jet tiller quieter. Like I, I know that I've, I've heard people say that they've contacted patients a day ahead of their visit to the nurses. I'm going to be speaking to you.
If you're agreeable, there's a clinical trial that you might be interested in so that people aren't of the mindset that when they hear of a clinical trial, it means it's the hail Mary pass. This means I'm, I'm at the end of the road. I have no treatments left because that's not the case. And I think that that's like, if, if that's, that's one important message I want to get out there. And I said this to people who have asked, what do you think I should tell my loved one? And in certain cancers, I would say the first thing that they should be doing is asking you about a clinical trial as a first line of treatment, not as first line of treatment, see if their doctor has a clinical trial to offer them, because that may be their first, their best bet as a first line of treatment out of the box. So I, there's a lot of educational pieces that need to happen, and I think it needs to happen at the site. And I think it needs to happen at the, with that, that there, we can't ever lose the, with all the great technology we have. We can't ever lose the personal touch.
Brittany
Yeah. You bring up a great point that I kind of want to chat about Anne-Marie with, you had this experience during, COVID when things are rapidly changing, and that brings about this whole new world of telehealth, telemedicine, and you talk about that personal connection and that human touch and healthcare. And now we're looking at things from an entirely different perspective. I was wondering if you could share a little bit of your thoughts surrounding your experience with that and what you think practitioners and clinical trials need to keep in mind as we move forward.
Anne-Marie
So I'm a big fan of wearable technology. I'm absolutely a big fan of wearable technology. I took my watch off because Siri was talking back to us when I didn't want her talking to me. I don't know what one of us said that made her think we were talking to her.
I think that there's so much to be gained using technology as long as we don't lose that human connection.
Like I just had a booster shot. I have an underlying blood disorder that I was born with and I've known about, and didn't realize that, oh my God, they keep talking about immunocompromised. And I don't, I'm thinking in terms of their list and here I am.
So in any way, in any event, long story short, I have, I have series of conversations with doctors, get an antibody test, ship it over to PIs that I know to have them try to analyze what they're seeing, but, but my, this, or the ring that I were picked up, the temperature spikes both time after my second shot and my third. And it was huge. My temperature spiked by almost five degrees after the second shot and after the, the third booster. So in the event that we're using wearable technology in the context of a clinical trial, which I am a big fan of, I think because the doctor is only seeing the person in that small window of time and what's happening in the two weeks or three weeks in between visits. I think about my mom and how she literally bounced into the doctor's office before her very last chemo and was saying how wonderful she was.
And I'm just sitting on this side saying, and you are today. You're wonderful, but yesterday you could barely get out of bed. And so, so the, the communication, and I know this, isn't answering your question and I will get to that. But if the doctor had been looking at some sort of a wearable, he would have known and said you're telling me you're great, but I can see from the data that we collected from your wearable, you barely walk 300 steps a day for the last two weeks. So really, were you really that good? At one point he looked at me and said, you're keeping her on it because. I said, mom, you were barely off the couch. Your appetite only started coming back yesterday. You haven't really eaten for over the last two weeks. I remember him saying to her, she's here to keep you honest.
So I think that, but I do think that the opportunity to incorporate things like telehealth is a wonderful thing. As long as it's being done in a way that I was in my home, my mom was in her home. He was in his office. They couldn't figure out how to get the three of us in one, on one screen without using a, you call me and then I'll call you. We'll conference in on a telephone. I'm like, really, it I've been, like on a zoom screen with a hundred people. And I can't get, I can't, I can't get a visit where we can all see each other and talk to each other at the same time. So, I think taking all of this into account, we have the greatest tools in the world, as long as we're making sure that we're, we're adhering to whatever privacy concerns there are with the platforms that are being used and making sure that everybody that needs to be in the conversation is part of the conversation and allowing for the fact that, for example, in COVID times, my mother and I were staying away from each other, I knew I needed to, pre, this was pre-vaccine.
She passed away in October of two thousand, 2020, we didn't have vaccines until two months later. so, even though I wasn't going out, unless I was fully masked and all of that other good stuff, and I wasn't going anywhere, anywhere, everything was getting delivered, but I still was like, I don't want to take a chance that I'm going to get her sick. So if the tools are there, how are we making it so that we're making sure that the tools are being used in a way that's helpful to people and not just helpful for one side versus the other. It's gotta be helpful for everyone for it to be widely in use and to feel like there's still a connection. I mean, I, there was a point in time where she called me and said, I just know my treatment isn't working. He told me a whole bunch of stuff. I don't remember what he said. All I know is, do you have a pen? I said, yes. I told him to spell the name of the drug that he's going to put me on. And that was, that was all the information. I had: the name of a medication. And then I had to go do my own homework. So the challenges.
Aaron
The way the tools are getting rolled out and I know that there are actual legal requirements and considerations that have to be made. It does seem like a lot of these moments where there are opportunities to engage patients in a more seamless way technology, even the ICF thing, bring people in earlier. I've had a lot of conversations over these last few years, working at Clara, where everyone seems to just sort of hide behind the structure of like, oh, well, we gotta, we gotta talk to the lawyers and they're not going to let us do it. And you just think to yourself, like, really, we really can't get a transcript of a video call that happened on a teleconference thing. That's already HIPAA compliant. Like, what are we doing here? And the burden just ends up falling to the patients or the patient's caregivers and it's a ridiculous situation just to hear about it. no, no question just pontificating.
Anne-Marie
And you're a hundred percent, right. And, and the, the, the, the person that's least equipped to handle the burden is the patient because the patient is juggling. they may be juggling family obligations along with some sort of therapeutic intervention that may be, knocking them for a loop. And now we're going to throw some more burden on them and say, we actually have to come into the office so that we can throw you in a room. This, and this really did happen. My, for, for the, while COVID was going on in April and May and June, she, my mom was going into this, the, the, the center for our visits and for blood draws, it wasn't for treatment. It would be because she was on oral therapy, taking it at home, but she never met with a doctor.
They brought her into a room where she had to go to the center to go in a room, to have a teleconference with a doctor I'm like, seriously, what, you're, you're being asked to put yourself at risk walking, actually leaving your house to go to a medical facility where you, I mean, I know they were, everyone was super careful, but still you're exposing yourself to people that you're walking past. And everyone, temperature checks, which we now know are not necessarily helpful. especially now that we learned people were symptomatic for three days before they even had. So the whole thing was, you're making her go into this center, you're making her go into a room and then someone's coming in and pushing a button. And, and, and there's a big screen and the doctor is on the screen and you're sitting in a room by yourself. Why couldn't you do this from home? Why couldn't you do this from home? And I know, I do know that, the FDA last year relaxed a lot of those requirements because of the situation we were dealing with. But there were some institutions that dug their heels in and said, we don't care that the requirements are relaxed. This is the way we have to do it, to be HIPAA compliant, to be this, to be that, to be the other thing. And I'm like hmm, I'm not buying it. So, yeah.
Aaron
Well, literally everyone else seems to be doing it. I'm not sure why you can't. It's strange. Sorry, Brittany, I cut you off.
Brittany
No, no, you're fine. I was just digesting that story of exposing yourself only to go in and look at a television screen. Like that's kind of, that's what we're talking about here, if not using technology effectively and not taking the patients into consideration. So, sorry that you had that experience.
Aaron
I know we're kind of coming up on time here and you've been so generous with your time. if you had like, if you had one thing on the horizon that makes you hopeful about the way things are changing, maybe due to COVID maybe due to just more engagement with patients earlier and earlier in the process. Is there any one thing that you might highlight as the thing that you look towards that gives you a little hope or a lot of hope? Hopefully a lot of hope.
Anne-Marie
I am very hopeful and excited about, again, the use of digital technology and wearables and how, how those can be incorporated within the context of a trial to get a true snapshot of the real-world experience beyond the clinic visit. So that, the data scientists can pull this data out and see what's happening in between those clinic visits. And, and, I know that there are wearable tools to be able to see how, I mean, I always say, if a doctor can't see how well or how easily a person is able to get onto the exam table or off the exam table, then the, they're not, they're not CA so as long as we can continue making wearables that are going to be able to give a sense of, what you look great today, but over the past two weeks, I noticed that you're not doing this.
Or, you, it seems like you're, you're, you're, you were less active or it's taking a little too long for you. And I know that there are, there are devices for, for pretty much everything. So I'm hopeful that we can get these things medically validated so that they can be used as companion devices within clinical trials, especially when you are putting someone on a treatment that may have side effects to make sure that quality of life is taken. It is walking side by side with a therapeutic to make sure that, okay, in killing the disease, if this is going to be something that, okay, you're going to tell me I'm going to be miserable for two months. But at the end of the two months, I'm going to get all my strength back. But if I'm going to be, I have to be on something for a very long period of time, then I want you monitoring my quality of life.
And I'm super excited about the use of how my digital technology and wearables that again, have been clinically validated by FDA or whatever regulatory body needs to validate them for use within clinical trials. That makes me excited. And that gives me hope that it's good, that, we're going to end. We're going to make sure that no patient is left behind whatever we're, whatever we're rolling out. If it needs to be uploaded into a cloud, if it needs to be stored on a device, if the device, I don't want there to be people that can't use the technology, because they're either tech challenged, like full disclosure. My mother was tech-challenged. if I would have handed her a smartphone and said, this is what I want you to do. If that was the only thing on the phone, she would be able to do it.
If there were more than three icons, she would be like, it's a smartphone for a stupid person is what she used to tell me. I'm like, cut it out, mom. You're not giving yourself enough credit. But we can't be creating more disparities by having broadband deserts the same way we talk about food deserts. There can't be situations where we're advancing this great technology, but we have these pockets of, of, of very large areas where we can't reach because of broadband access. Now, the flip side of that is you do have an opportunity. If the infrastructure is in place, you can reach more rural patients and get them enrolled as a clinical trial. So I am hopeful and excited that we can advance all of this, but we have to just think going into it. How do we make sure we're not leaving anyone, anyone behind, no patient left behind? That's my mantra.
Brittany
What a great note to end on Anne-Marie, thank you so much for sharing, and thank you so much for your time. I'm really impressed with the work that you're doing as a Patient Research Advocate, and I'm looking forward to all the things that you'll be bringing to the table in the future.
Anne-Marie
Thank you so much, both of you. This has been an absolute pleasure, and just keep getting the word out, keep doing what you're doing and make sure that everyone, everyone that hears all of the work that you're doing is, getting educated about what they should be asking their doctors and, is a clinical trial appropriate for me. And, what's out there that I might be qualified to participate in to make sure that we are advancing science, because at the end of the day, science is science. If we've learned nothing over the last year and a half, we can move very quickly when we're, when our backs are up against the wall. Although people like to think that the vaccines happened in a year, those of us that know, understand they were working on these things for probably 20 years, that technology was in development, but they were able to pivot real quick. So I'm just hopeful that we're just going to keep pushing the boundaries and trying to get more and more people to buy in and realize this is: what are the risks? What are the benefits and make the decision that's right for you. There's not one size fits all, but there should be something for everyone out there. That's my closing statement there.
Aaron
Absolutely. Thanks so much.
Anne-Marie
Thanks, guys.
Brittany
Take care.
Anne-Marie
This was great. Thank you so much.
