The Clara Team is excited to introduce our limited podcast series: Trial by Fire, which chronicles candid clinical trial experiences and discusses how we can tackle these issues as an industry and work towards creating a system that takes into account a diverse set of patient perspectives.
Our hosts, Aaron and Brittany, are joined by Richie Kahn in our first ever Trial By Fire episode. Richie is a clinical researcher, patient advisor, and health policy professional. In this episode, Richie touches on his experience living with Wolfram syndrome, finding support from Paralympic athletes, and his insights into patient engagement in clinical trials.
Transcript
Brittany
Hello everybody. And welcome to our first episode of our limited series Trial by Fire, 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 and I am joined here by my co-host Aaron.
Aaron
Hello.
Brittany
And we're so excited to have our very first guest on here, Richie Khan. Richie is intensely passionate about incorporating the patient and caregiver perspectives into the clinical development process and ultimately reducing the time it takes to bring promising new therapeutics and diagnostics to the market. He's the Senior Director of Patient Success at Medable. So thanks Richie so much for joining us.
Richie
Thanks so much, Brittany, thrilled to be here and the best part about being the inaugural guest on the first recording is there's nowhere to go, but up from here. Woo.
Brittany
That's very true. Thanks so much for volunteering to be the very first one, super excited to chat with you. Now, before we get into your story, which I hear is a great one, I would love if you'd take some time to share with our listeners a little bit about your background and your story thus far.
Richie
Yeah, absolutely. So I am a health policy professional by training, clinical researcher by trade for the last 12 years. And I was actually working in full-service ophthalmology, so developing new products for anything to do with the eye. when I found out that I am losing my vision. It looked like a pretty clear-cut, early onset case of glaucoma. I got the original diagnosis. I went six for six on the testing, and I immediately put on both my patient advocacy hat from my public health days and my sales hat because that's what I was doing at the time. And I started tracking down nonprofits and advocacy organizations really, really zeroed in on the Glaucoma Research Foundation. And I said, hello, my name is Richie. How can I help you? Over and over until eventually, they said, well, we have a couple of ways you can get involved.
One thing led to another. I found myself getting a third opinion from one of their key opinion leaders. And he was a little stumped. He said, with relatively few signs or symptoms or clinical manifestations, you've lost about 15% of your vision. And it was through no fault of anyone. It's just treatment guidelines are what they are. I wasn't due for another examination for three or four months. So we said, all right, figure out what's going on. This looks and smells a little different than clear-cut glaucoma. Started looking to see if I had any evidence of the stroke, a transient ischemic attack, brain tumor, everything looked normal, so to speak. I went to the neuro-ophthalmologist. He wanted to tear his hair out and eventually in sheer frustration, he said, let's swab his cheek and do some genetic testing.
And several months later, my test results came back just before everything shut down here in the U.S. for COVID. I got a phone call on a Friday that said, doctor so-and-so would like to speak with you Monday morning at 12. Thought that was kind of weird, but all right, I'll chat with them. And chewed my fingernails all weekend, got on the line with doctor so-and-so. I could hear him Googling what he was about to read which made me very confident, but he essentially said, Richie, this is Brittany calling. And I want to let you know, I've got your test results, they are a hundred percent conclusive. You have a genetic condition called Wolfram syndrome. You need to talk to your geneticist, right? And he can hear me click-clacking away. I'm looking at the same information he's looking at. And we now realize it's an unspoken thing.
The gentleman has told me that 70% of patients are dead by 30. I'm now slightly older than that. Despite how youthful I may look. And the way you expire is very similar to patients with Lou Gehrig's disease, your brain stem atrophies, and you forget how to breathe. So I can hear the guy taking the phone away from his ear. He's about to slam the receiver down for what was arguably a very uncomfortable conversation. And I think he has sent me the frigging test results. So I get the results. The next day, unfortunately for my wife, I had to fly to Florida for a work conference after sharing this news with her.
And I did some research. I tracked down the key opinion leader in the world, who's a doc out of Washington, University of St. Louis and he very kindly offered to schedule about an hour later that week with me, my wife, his research nurse and himself. And he was talking us through the particulars of Wolfram syndrome. And eventually, he says, do you have any questions I didn't cover? And I said, well, this all makes sense. I think I've got a pretty clear understanding of what you're telling me. Cause I've, I've read a lot of the literature and he looks into the camera for Zoom and goes, ''Don't believe what you've read on the internet.'' And I kind of went, let me, I'm a little confused, cause everything I've read, you're the lead author and he laughs and he goes, yes.
Most of what I've written is about Wolfram syndrome. You have Wolfram-like syndrome L-I-K-E. And it kind of went like the record skipped and good news is my brainstem is not atrophying. It's a much more milder form of the disease, but my particular flavor of dysfunction, my genetic mutation was discovered by science a couple months before my diagnosis. I am patient 17 and the other 16 developed optic atrophy. So depth of the nerves between the eyes and the brain between six and eight years of age, they had some visual impairment, tended to progress rather slowly. I was generally mild. Two years later, most became insulin-dependent diabetics. I'm going to have a birthday in a couple of weeks doing the math, I guess I'll be 36. I am not diabetic. I'm not pre-diabetic. As of November of 2020, so 12 months after learning, I lost 15% of my eyesight.
I found out I've now lost at least 45. So I saw an opportunity. I'd been traveling 70% of the time in a sales role at a contract research organization and wanting to travel less and wanting to spend more time with my wife and my dogs. And I really wanted to get back to advocacy and I kind of figured I am super privileged as a crusty old white guy in this industry who knows how the sausage is made with clinical development and also can wear that advocacy hat. Clients tend to want to listen to what I have to say and no matter how dumb it is. So I kind of took it as an opportunity to platform others who either haven't found their voice or get shouted down. And one thing led to another. I started making that transition into advocacy first consulting for metal as a member of the Patient Advisory Council for going on two years.
And the timing was kind of serendipitous when they reached out last November and said, we've got a full-time opening on the team. Are you interested in coming on board? Because the vision loss had really accelerated. I decided to accelerate the transition and I said, well, I really enjoyed the work. I enjoy working with the team. I love that the heart of what you do is incorporating the patient and caregiver perspective into the products and technology is being designed. But I've got to ask what's the opening? And my friend and clients said, ''Well, what do you want it to be?'' So I said, all right, if I can write a job description, really laser-focused on this work, I get to work with fantastic patient advocates. And you know, I get to educate and do some thought leadership subject matter expertise that really helps position the vital importance of incorporating these perspectives into clinical trial design. I'll be happy as a little clam. And I came on board full time in April. So that's what I'm doing professionally. It's a little background on me personally. you know, obviously I mentioned a lot of the ophthalmic manifestations of my disease, but like everybody else, I'm a rare disease guy. I work across indications and therapeutic areas. So that's a little bit about me.
Aaron
That's, that's an incredible story.
Richie
There's a lot, I know.
Aaron
Well, I mean, there's, there's a lot to get into, right. Brittany, I'll let you kind of lead the discussion, but yeah, I'm just kinda curious even in just that moment in time when you were getting that diagnosis and getting connected to the doctor and then to the key opinion leader, as COVID…it's kind of like, I guess we didn't really know it at the time, but as COVID is about to bear down on us, did that impact any of that diagnosis journey, did you find it more or less difficult? What's the guy like more online than he might have been otherwise?
Richie
Yeah. Great question. The lawyerly answer, I guess is, it depends, right? So I was able to connect with Fumi. Wash U I believe was supposed to open a new genetics facility last July. I know that was pushed out a bit because of COVID. I was going to go and visit not only to see Fumi but with my particular condition is treated very much like glaucoma. So I take eye drops twice a day. I do a visual field exam. I've got a couple of headsets in my office. I can do them at home. I do imaging of the optic nerve. We check my eye pressure, but really it's all about treating the symptoms for me taking the medication. Doesn't really have any benefit. There's a potential benefit of neuroprotection, so protection of those nerves, but as the patient with Wolfram syndrome, the problem is your optic nerves are not as hardy at birth, right?
So chatting with Fumi, we said, look we need to build out a care team with a specialized endocrinologist. Fortunately, I've got the perfect person here in St. Louis. We need to get you connected with the neurologist. You really trust them the migraine patient. So I've got a good neurologist there. They didn't have to be an expert or familiar in my condition at all. Really. It was more a matter of keeping tabs on the brain stem in case anything happens there. I'm working with my ophthalmologist here in Durham, North Carolina, to sort of captain the ship, but the idea was I was going to go out to St. Louis and I was probably going to spend a couple days with Fumi with his team, as I mentioned, I'm patient number 17. So I'm sure there's a lot of information you'd like to get from me.
And I wasn't comfortable traveling. So at the time I wouldn't say telemedicine was freewheeling. There was a lot more flexibility. So he's not licensed and boarded in North Carolina, obviously, I'm based here, but he was able to see me remotely, but I haven't been able to see my doctor, to have them lay hands on me. At the beginning of the pandemic, I was doing a lot of research comparing these visual field analyzers and the value you can get remotely compared to standard of care in the clinic. And I wasn't comfortable going to see my eye doctor. I mean, that's a lot of really close in your face kind of work when they're checking out ocular pressure. And I was chatting with one company and they said, boy, we'd really like to see any results you can share from the clinic.
And a few days prior I'd canceled my in-person appointment. I think I wrote a two-part piece about this for Glaucoma Today, but I canceled the appointment and I realized that for all the millions of dollars they had spent on an electronic health record system, it did not have the ability to print visual field exam as a PDF, upload it and send it. So that meant if I wanted to get my hands on these exams, I'd have to go into the belly of the beast pre-vaccination for anybody. And I knew exactly where I'd have to go to pick up the paperwork. It was like 300 feet into the very center of the clinic. So I called back and I said, ah, that's a really awkward, I'm sorry, but is it possible to reschedule? And they said, yeah, we can see you in six weeks.
So I went, all right, let me pick up the paperwork. But when I came back in six weeks, it was a completely different experience. They had 85% fewer chairs in the waiting rooms. You know, everybody was wearing PPE, masks were required, the docs were wearing face shields. I'm never that confident that anybody is doing a good job cleaning inside the visual field exam machine. I don't know if you've ever taken that one where they put your head in this little holder and you have a little joystick, it's like a video game. So I know they wiped down everything you're touching, but your face is just in the middle of this open box. It's comfortable. So in summary, I still haven't made it to Wash U. I'm fully vaccinated, boostered up. I guess I could travel if I was comfortable, but for my particular case, I haven't really seen a lot of value because the care's not going to change. So definitely in a different world, I would have done like what I was doing pre-pandemic, which is just traveling kind of willy nilly. I've got a ton of airline points I haven't used from when I was traveling full time. It would have been at Washington University in a heartbeat. So that's definitely different. And you know, depending on the indication, different specialties we're making for a better and more frequent use of telemedicine than others. It's definitely not being the same across the board.
Brittany
Yeah. What a time to go through a diagnosis like that. Like, I can't even imagine.
Richie
One of the kind of cool things about it is that I'm not traveling. So I save however many hours every day. And I got connected originally through Clubhouse, back in January, we can argue about the utility of that platform, its functionality, but with the support group for the visually impaired. And I started chatting with a couple of people who during the pandemic, a good friend of mine woke up and he had lost almost a hundred percent of his vision. Right. Other people, it hasn't been so severe or as progressive. Number one, your problems are what your problems are. It still puts things in perspective. But it was interesting to plug in with that group. And then I've been really fortunate in addition to being able to tap into that really fantastic network of advocates.
I found myself falling into a network of blind Paralympic athletes. So whenever I'm feeling like I need a kick in the butt to do something, I'll just reach out to my buddy Tucker who lost 70% of his vision at the age of 16 and has three or four gold medals to his name, that I kind of go, all right, this is a good reset. It's nice to expand your network and be able to learn from those who've come before you, right. I mean, going blind is a pain in the butt. It's not the worst thing in the world. You can certainly adapt, but it's great to be able to pick up lessons learned and to avoid pitfalls that many others have experienced. So hopefully it's a little less burdensome for you, you know?
Aaron
Yeah, absolutely. Nice to have very fit friends as well, just to like, or I guess more advanced in some stuff.
Richie
And Aaron, what's so funny. I connected my buddy I just mentioned by name with the gentleman whose name I didn't mention who lost all of his vision. At the beginning of the pandemic, they had the same rare optic atrophy and the gentleman who lost his vision very rapidly, said, well, I'd love skiing. I wonder if there's a way to get connected with an adaptive sports organization. And next thing he knew he made a phone call and he was too polite to say, no, they offered to get him trained up to do a triathlon with a guide, the entire experience, fantastic training regimen. And what can I tell you? He's hooked, he's now done at least one as a visually impaired athlete. So he might be going out for the Paralympic team. This is wild, wild times we are living in.
Brittany
So are we gonna see you in the Paralympics at all? That's what inquiring minds want to know?
Richie
You know I will freely admit. I finally, I reached out a couple of weeks ago. I'm waiting to hear back when some of the team members get back and decompress from Tokyo. I said I'm a half marathon guy. I can do a 5k and not the fastest, but you know, let let's talk. So we'll see.
Brittany
Yeah. That would be awesome. Well, thank you so much for sharing your story and a little bit about your, your struggles in the, in the COVID world. I appreciate it. So, yeah, it is. It's very real (Laughter) I would love to get into your your endeavor in insomnia trial and kind of what your experience was particularly surrounding informed consent. So, yeah. How about you tell us a little bit about that trial, how you found it, kind of walk us through what all went down.
Richie
I'll give you some background. Here's what had happened. I was a couple months from graduation, like I mentioned, a Master's in Public Health. I was working for a hepatology nonprofit, the Hepatitis B Foundation, the largest organization of its kind for patients' loved ones and clinicians. In the Hepatitis B space I really, really enjoyed the work I was doing. And I started dating somebody who was also in Public Health. She was teaching sex ed in Philadelphia, public school through Planned Parenthood, and things were going nicely. I was kind of hopeful that maybe she'd give me a shot long-term and I knew that two nonprofit paychecks weren't going to pay the bills. So she was working late one night or had better things to do. And I said, I'm going to get a pizza and get a six-pack of beer. I'm going to plant my butt in this chair, and I'm going to start researching, what can I do with this skill set? And this must have been very early 2010 because you were still able to go into Craigslist and find ads of value. You were still able to discover clinical research. And I started seeing ads for a position that had words like feasibility and in clinical research and writing things down, I've got a million tabs open. This is all completely new to me, right. And fast forward. It's now mid-February, 2010. I'm still living in Philadelphia where I'm born and raised. E-A-G-L-E-S Eagles, SuperBowl champions for life. It's usually very mild.
Aaron
Actually Richie remind me, I do have one positive Eagle story that I'll tell at the end.
Richie
Okay. I'll try to remember that, Aaron. So the weather is usually very mild. We get 18 inches of snow per year. And the day of my face-to-face interview for this position, I learned about, we had our second back-to-back blizzard. We had a third one that year. We wound up getting 78 inches of snow. It was the second, most severe winter we had in history. My now wife we’re celebrating an anniversary and about a week and a half, she's dealt with me since then. She's a Central California girl. She's from the, she's from Fresno, Central Valley. So nowhere quite as enjoyable as San Francisco, but it's not her fault. She'd been going to school in Boston. She discovered snow the hard way, you know, we wound up, we were going to be moving. That's one of the things we learned through this first day in research, but I get to this interview.
It's an absolute nightmare logistically, but at the end they said we really thought we needed someone with a clinical background, a nurse practitioner, PA, or foreign med grad. Now that we understand the value of a Public Health Degree, let's bring you on board. So I'm working, I'm doing my thing. And over my lunch break, call it on a Tuesday. I said, you know what? I'd really like to get involved in research to get more skin in the game and a better understanding of why we do what we do. And I found a clinical trial listing at that point. I haven't thought about it in years. It was probably also on Craigslist, right? It was like a gig or part-time job. And I see an ad for a phase one study, the large academic medical center. And it's an inpatient study over a couple of weeks. You come in Thursday, five or 6:00 PM. You check out Sunday morning at 11, they're going to pay you $3,100 to hang out, make some new friends, play Nintendo 64, or whatever we had in my day. Eat some snacks and sleep on like a Craftmatic adjustable bed. I said okay.
Brittany
Sounds like a party.
Richie
Yeah. It sounded like a party. I said, this is great. And maybe I can contribute to the body of scientific and medical knowledge, have some insight into why I don't sleep so well. So I emailed the anonymous person on the other end of the line. I think they asked for a phone number and I got a very excited phone call. First of all, I sent this email when I'm at work on like a Tuesday, I get a phone call on a Thursday.
And ''Is this Richie?'' Speaking? ''Hi Richie, this is Aaron from doctor so-and-so's office at university of such-and-such. I heard you're interested in the insomnia study, so yeah. Great. I'm going to send you an informed consent. Read it. Let me know if you have any questions.'' Click. I don't, I don't know any better, but this doesn't feel right. So she sends me, the coordinator sends me a 38 page single-spaced informed consent. I think I know why I'm going blind. It's possible it was from this poorly designed consent form, who knows, but it's now Thursday and I have this thing printed out. I look like Jimmy McNulty from The Wire with like the red string everywhere, connecting the suspects for the criminal narcotics trafficking organizations, paper everywhere. I've got to like pink highlighter and I'm going to town on this paper.
I'm highlighting them, highlighting them, highlighting and taking notes. And everything seems, I guess reasonable, pretty unexceptional. From what I gather this is a first in human trial. They're really interested in pharmacokinetics, pharmacodynamics of the movement and absorption of this particular drug. And they're really interested in glucose metabolism. I don't remember why. You'll see why you don't remember in a minute, but I get to the bottom of page 17 of 38. It's like paragraph four of five and it's 11:00 PM on Thursday. It's like the second or third weekend you're in there and you're hooked up to an IV. You know, they're going to feed you some toast. I think with jam, then you're going to take it what I learned was a nap. I thought you were going to bed. And I start reading at 2:00 AM the clinical team's gonna come in and they're gonna lay you prone on your belly.
And I kind of went, okay. Everybody knows what the prone position is now due to COVID. I vaguely remembered from my time as an emergency medical technician, but I kind of went, ooh, that seems important. Let me take note and what really got my attention is the next few lines where they said Brittany, after we lay you prone, we're going to lift up the hospital down and we're going to take a biopsy one inch wide by one inch across by one inch deep of your left butt cheek. Why can you guess why? So I picked up the phone, I called the coordinators. They're like, I don't want to waste anybody's time. I’m out. Oh, okay. Didn't ask any questions then. So right. You're not going to be involved in this trial.
I got a phone call. I was working my first job in research. It was a contract gig. It was like month four or five. I get a phone call. ''Hey, this is Brittany from doctor so-and-so's office. I'm the coordinator with the insomnia study.'' And I kind of said, ''Hey, Brittany, what, what happened to Aaron?'' Oh, so I'm calling. Aaron couldn't recruit patients, huh? Well, Brittany, I'm curious. I don't know if they have any of the informed consent or have changed the process, but my recollection was there was a pretty substantial biopsy that was required from a patient. And no one explained why or gave you a heads up or covered anything by phone. It was just curious that really dense IRB-approved, but not patient friendly anyway, 38-page informed consent. Good luck. Has this changed at all? And I think the answer was not really, the only thing that's changed is staffing.
So different institutional review boards have different standards. Yeah. I'm sure they probably work with a central IRB or at least a combination of central and local now, but you know, some problems I'll throw out and we can take it however you see fit. Right. I think the informed consent process, and it's an ongoing process, is the best way to begin building rapport to build that relationship, to make an impact positively or negatively on engagement and retention. Best practice is always to have that conversation. My wife is in the other room here is an active clinical trial participant. She's in the Pfizer COVID trial and she's now rolled into the booster study. She was highly motivated. They needed women of color. She's a Latinx woman and she really, really wanted to contribute to getting the vaccine out there.
So she goes to the clinic for her first visit and she knows the facility because I used to work in vaccine research. I used to work very closely with this group and they would win awards every year for Best in Class Patient Experience. And from the get-go, it’s absolutely miserable. They wind up giving her the informed consent and putting her in a quiet room by herself. No conversation. There was no, let me talk you through some of that. Here's some things to look for. She was and remains highly motivated. She didn't let it detract her. She qualified, she enrolled, she found out in February. She'd been fully vaccinated in September of last year. She was subsequently rolled over into the vaccine booster. They continued building that tremendous rapport by not mentioning the placebo control. She found out when she went to review the informed consent in person, the same exact process.
And she's sitting here in North Carolina in the belly of the beast feeling like she's not fully protected. She could walk into a Walgreens now and get a third dose within minutes. And she's just so motivated. She's sticking with it for the trial. I sincerely hope they ask for feedback, but you know, if you're not building rapport, if you're not using it to educate, to dialogue, to build engagement to make patients feel like they are invaluable parts of the care team you are sincerely missing out. And you know, it doesn't even speak to the patients who wouldn't be as motivated as my wife, who just would say, you know what, this isn't for me, we know 86% of trials fail to meet timelines. And we know the biggest chunk of delays are due to patient recruitment. Well, let's start using informed consent to build rapport and to build a relationship for the current trial and future ones.
Aaron
Yeah. I love that way of putting it. I've never heard it put in such a way, and I hope you don't mind me just stealing that language from you for future conversations.
Richie
You got permission, absolutely. Run with it.
Aaron
I'm kind of curious about this transformation that we've kind of all gone through as an industry in the beginning. Certainly a lot of talk and a lot of like very, I thought pie in the sky visions of like, well, this is the future. And now everything will be, you know, and then insert your buzzword of choice. Right. And like virtual decentralized whatever it was. And I'm wondering if you've seen any good applications or any poor applications, maybe at that informed consent level of like virtualization, like for example, like I'm, I'm a little surprised that your wife had to go in person and then sit in a quiet room to review informed consent papers. Like that seems like it could have been a little more remote virtual, a little more interactive, maybe. So, I, I'd love to hear about your perspective or your experiences in that stuff.
Richie
Yeah, absolutely. So when I'm not on fantastic podcasts like this, as Brittany alluded to earlier, my full-time gig is Senior Director of Patient Engagement at Medable. So Medable has an entirely patient-centric platform for decentralized clinical trial conduct. And what I mean by patient-centric is everything is pressure tested by patients, caregivers, care partners go through user acceptance testing. Not only does this work as intended, but does it work as a patient would expect as a patient requires? You know they’re certainly a leader in the field.
There are a number of others doing this work, but I'll step back and say if there's one silver lining to the pandemic, as it relates to research, I think many have been forced to confront how we've done things traditionally. Right? I mentioned the stats about clinical trials failing to meet timelines. For every day your trial is delayed and your product. Let me rephrase that. Every day your product is delayed from coming to market, depending on indication and market share, you can stand to lose between 600,000 and 8 million dollars. Obviously, we don't have nearly as many blockbuster pharmaceutical interventions anymore. We have a lot more high price, but highly necessary rare disease products for much smaller population. But the fact of the matter remains traditional patient recruitment does not work in the U.S. alone. More than 70% of potential patients live more than two hours away from a clinical trial site. When you have a traditional study being conducted at a brick and mortar facility, five visits you know, maybe the first one is the opportunity to confirm every bit of data gathered during pre-screening to do some more in-depth screening, informed consent, randomization enrollment, and medication or IP allocation, right?
Fifth visit, close out, return anything that's left. Why do we need to make those patients for visits two, three, and four, come in to conduct reassessments that can be done remotely, electronic patient-reported outcomes using telemedicine? You know, think about that. You're the patient, most clinical trial sites don't operate evenings and weekends, right? So you've got to take time off work. I mentioned earlier my visual impairment, I don't really drive anymore. So I can either get in an Uber, which I'm not comfortable doing during the pandemic or my poor wife has to schlep me around. She has to take time off work. I mentioned the fur babies, someone has got to deal with them, right? There's no childcare, but you're talking about innumerable logistical challenges, barriers that are inadvertently narrowing the potential patient pool. And in the past, when we went through the site ID site identification process, we'd say, Hey, doctor Brittany, we've got this fantastic ALS program. Here's the protocol. What's your patient funnel look like? How many patients can you enroll? And maybe the 10 and the bottom of the funnel was accurate. Maybe it wasn't, maybe you'd find out during the informed consent process where you're making patients come in. There's some hurdles that we haven't considered cause that protocol wasn't designed with patients in mind. Right. But what the pandemic has forced us to reckon with is standard operating procedure is not an option right now.
Now that we've actually done a lot of these assessments remotely, we know a lot of this works, right. It helps knowing that 70% of patients can't travel to a site because it's more than two hours away. It helps potentially better engage and inform patients before they do come to the site. We'll get back to the informed consent part in a minute Aaron, just to close the loop just because we're doing things differently now. Am II confident we're going to be in a fully decentralized world anytime soon for clinical trials? Not a chance. But is there going to be more and more decentralization, more and more ECOWAS telemedicine, more of these patient-centric assessments and visits?
I sure hope so. I think that's definitely the trend. There are various regulatory considerations in the U.S. and abroad that have to be taken into consideration, but I think the key thing, two key things, number one, now we know it works. Number two, we know patients aren't looking to be told, we're going to go fully remote. We're going to go fully digital assessments for visits two, three, and four. They want optionality, they want choices, right? So with informed consent, one of the biggest hurdles I see for the industry, we've gotten really good at essentially creating a digital copy of that 38-page informed consent. Let's add value for patients. Let's make it digestible, let's make it meaningful. Let's make it easy to communicate with the site staff, with your clinician. Let's make it easy to share this information with your care team, your trusted family members, members of the clergy whoever it is, right.
And then obviously the informed consent is a function of whatever has been approved by the Institutional Review Board in the U.S. or the ethics committee elsewhere. We do a really lousy job of being patient-centric with how we phrase things. You know, what best practice is. Everything should be at a fifth or sixth-grade reading level. I look at a good number of informed consents or have my screenwriter share it with me, and we do a terrible job, right? And not only in terms of using slang that only industry would know, or jargon, I guess would be a better term, but I'm thinking about how we present this information, right? Very few of these tools are optimized for accessibility. So if you have a patient that's visually impaired, they want to be able to use a screen reader. They want to be able to magnify the text. There are a number of things we could do to really improve the process or ways that we can go from just simply having that digital copy of that Word document to really having a process, to having resources, to having engagement in discussion. So I know there's some brilliant people working on that right now, I think for the informed consent process and for e-consent specifically right now, that's really where we have to go.
Aaron
Absolutely. Yeah. I love the bit that you said about optionality. It does seem like at a broader macro level, like there's a conversation now happening about, are we ever going back to the office? What's the future of work, whatever it is, like what's the future of anything? And it almost, and it's like an exact copy of that conversation when it comes down to the clinical trials and the patient experience. It also seems like there's this weird thing that happens in an industry where patients are treated almost like an alien class of being and it's for whatever reason, hard to communicate these very simple truths, like, yeah, they're going to want options. They're going to want to be able to read this thing somehow. And then upon reading, they're going to want to understand things about the thing that they just read. And it does seem like there's this weird block in all of our, like, industry-wide brain that doesn't allow that truth to be readily administered and like accepted. But I guess that's just like me on some kind of a rant.
Richie
Yeah, no, I think you're spot on Aaron didn't mean to cut you off, by the way, there's a slight delay on the line. It sounds crazy, right, because patients are, are just, people are like everybody else, right? It could be anyone on the line. It could be your loved ones, family members, neighbors, right. But when we frame an interaction as being with the patient, a lot of people don't know the clam up. They're not sure how to talk. So often either they don't do it or they outsource the work to a patient engagement expert to have a conversation with interested parties, patients, care partners depending on the kind of trial, see what matters to them, see what pain points they're dealing with, what would add value to their experience and remove burdens. One of the things that I think about often… I mentioned, I used to be traveling 70% of the time for work, as a sales guy in the industry I was used to having 15-minute conversations, I'd fly to the Bay Area for coffee or a drink or dinner, I'd fly back the next day or sometimes the same day if I was really feeling wacky and had to get to Boston or something.
And I think a lot of companies like a Novartis, for example are shedding a lot of the office space they have. More companies are really providing that optionality. So if I were in a purely sales-focused role in 2021 you have to figure out how to engage and how to communicate with your clients, whether they're patients or sponsors in a way you never had before. Right. Cause you're so used to that in-person communication. I was laughing. I was talking to a buddy the other day who I met through a previous sales gig. I said, let's catch up over a virtual coffee or cocktail, the amount of people who not only want to reconnect and catch up. But most surprisingly to me, the ones who want to have a conversation for the first time, because even though we're all on Zoom all the time now, I think there’s still that thirst for human connection, different kinds of dialogue.
How do we sort of take advantage of the new ways to communicate? I hate Zoom but you gotta make it work when this is your option. Whether it's having a patient advisory board on Zoom versus in-person or engaging with a partner differently, you just gotta be thoughtful and we've got to figure out like, you know, I teach for clinical research, fast track, which helps career changers break into the industry. And my first class with fast track was just before everything shut down for the pandemic, I'm used to engaging with students now from all over the world. And you know, I had to, like, rewire my brain. How do I keep their attention virtually right now? You know, how do I add value for them? And one of the things I've realized very quickly and it, I'm sure it's every single day of your lives.
Now with every single meeting, I have a rule whether it's work or play with fast track. Life happens, dogs happen, babies happen the only rule of the road when I'm like leading a Zoom meeting. If I hear your dog, if I hear what sounds like, very cute baby, introduce me to the dogs and very cute baby. You know, this is weird times for everybody. We just have to be a little kinder and a little more accepting. So show me the dogs. That's another benefit, I guess, of, of research during the pandemic era. We're dog friends.
Brittany
Absolutely, all dogs all the time. I have three, but they have not yet paid an appearance on this podcast. So that was good.
Richie
My wife very kindly took ours out during the doggy witching hour, four to six is when all bets are off.
Brittany
Yes, there is indeed a witching hour for sure. Very familiar with it. I kind of wanted to circle back to you mentioning how important it is to have a dialogue with the patient during informed consent. I also think it's important. At least this is what I've heard from a lot of the patient advocates that I've spoken with. Do you have the opportunity for input when that study protocol is being designed to get that patient feedback before it even makes it to that stage? What are some of your thoughts around that and the importance?
Richie
Yeah, a hundred percent agree. It's vitally important. So for years we talked about patient centricity and patient advisory boards and we relied on sort of squishy metrics, qualitative stuff. I'm a qualitative researcher at heart, right? So that's the stuff I love. But for years, people would say, well, show me the value. Show me the return on investment. And the first time you really did that, I think was back in April.
It was a very last session of patients as partners. Ken Getz was presenting quantitative data. I believe they were looking retroactively at a number of studies, phase three programs conducted by a number of large pharmaceutical sponsors. And forgive me if the cobwebs are clouding my memory here, but some of the data he was able to show was incredible.. You can reduce the number of protocol amendments from six to five. You can reduce the number of data points being collected. You can streamline the outcome measures. You can save time. And that time is invaluable for patients. It's hugely valuable for industry and think about it, everything we do is geared towards getting new products to the patients and care partners that need them, right. And we want to do it as fast and as safely as possible. And if we're designing protocols, they're being authored in a vacuum by a very brilliant team of researchers who maybe came to industry after finishing a fellowship 15 years ago and they haven't seen a patient, they are laser-focused right. I'll give you an example. I remember five years ago at a pharmaceutical innovation conference, hearing a presentation about this really cool pilot, where they were doing some really novel stuff with patients and they were providing transportation.
I don't remember the indication, but I know it was an older patient population. And a lot of them had visual impairments as it turns out haha. And they were so excited. They were, they were stoked. So they formed this partnership with a ride-sharing company. They would drive the patients to the site, drop them off, pick them up, take them home. And they went to do the debrief with the patients and they said, Aaron, what did you think? And Aaron kind of scratched his head and said, well it was all right. And the researcher said, well, Aaron, what do you mean? Well, Richie, since you asked you took me to the clinic, you dropped me off. You pick me up, drop me off at home. My study is at a large academic medical center, the campus is enormous. I'm visually impaired. I need to walk half a mile from the front door and the researchers are going, oh no, because logistical challenges are real.
Transportation was a huge issue. Right. But because they hadn't connected with patients and said, Hey, I'm spitballing here. What do you think about that? No one mentioned you're absolutely going down the right path. Let's bring it home. Let's figure out how to get the patient to and from that research office, right? So that's the kind of feedback that is so, so important. You know, it could be getting patient-specific input on a device or wearable, Hey, this thing works great, but it's ugly. It doesn't charge and it's not appropriate for my therapeutic area. We don't tend to gather that kind of information. So it can go a long way for protocol development. And I think the last thing I'll say on that topic, Brittany, it's vitally important to not only get that feedback at the beginning before you've drafted up that protocol synopsis.
If you want to avoid six different protocol amendments. But pull it through the entire process through closeout and hopefully marketing approval, right? Because it's only going to behoove you. It's going to save you time and money. It's going to save patients a lot of aggravated frustration. And the other thing I'll say is even before you're planning the synopsis, talk to patients about what you're planning on, develop, figure out, is there a need? You know, I was talking to someone the other day who had this very complicated device for patients with visual impairment. And you had to put in numbing eye drops. Well, that happens when you go to the glaucoma clinic and there they're testing your pressure. You don't do it yourself as a patient number one. Number two, patients are never trained how to take eye drops. I thought I knew I had no clue how to take eye drops. I take them twice a day for glaucoma 5% of the medication you get to the intended spot. Okay. So there's huge ways. There's inconvenience, there's redness or swelling, there's irritation, all of these things and they were suggesting the patients have to take another drop, you know? And I said, I, I feel where you're coming from. Let's probably consider talking to some additional patients here, you know?
Aaron
Oh yeah. I never even thought about the eye drop thing. That's just, like, weirdly blew my mind. I know we're coming up on time too. So thanks for offering so much time and all these great stories. I was wondering, so on a personal level, I think everyone who gets involved in whatever level of research, they're all really keen to help people. I think intuitively they know, and they want to speak with patients to figure out how to better help or administer aid or whatever it is. Then it kind of graduates up and up and up until there's a layer of infrastructure that's like not human anymore. So there's institutional review, there's compliance review, there's legal review and all those folks also want to help on an individual basis. But I think the machine starts taking over and it either, like, flattens the input that patients have offered from three-dimensional to two.
Oh, just give them a car. Okay, great. Done next. Or it disincentivizes folks from even wanting to engage with patients because they foresee this really painful, legal experience in their future were they to go down that path. I'm wondering if you've been able to help graduate past some of these friction points for the folks who you've worked with or worked alongside especially now during this still ongoing, COVID this endless COVID era where things continue to morph and morph and morph and things are getting amended and people are trying new tools. So this friction layer I think, has been very present in all of our lives and we're trying to get solutions out the door.
Richie
Yeah, absolutely. Have I helped? I don't know, man, I'm trying. One of the things I always fall back on is the importance of that clear, concise communication. However, you're doing it right from your first interaction with patients. Talking with some fellow advocates, sometimes we'll laugh a little bit, I'll say, does anybody have a good template consulting agreement for patient advisory work? And everybody laughs they've got a hearty robust chuckle thrill, like Santa Claus ho ho ho ho. And then I'll wind up getting 15 different versions of like super dense, legalese-rich, 12 to 15 page agreements that are appropriate for like marketing consulting. Right. It's not for a patient. Right. So I think the communication is something we can really improve upon. I think the biggest thing we can really do to improve any of these interactions is help everyone have a clear understanding of not only the patient experience, what they're going through, what, what it's like to be a clinical trial participant or caregiver.
But to also explain if you're working in data management or product management and you're really pretty far removed from patients, let's talk about why the work you're doing matters gets you connected to actually converse or better yet learn from actual patients, preferably clinical trial participants, because if we can do a better job setting the stage at that base level of understanding, we can do a better job ultimately serving our customers patients, right? So I think that's gotta be the guiding principle. I think there's more work being done now than pre-COVID to you know, everyone needs to say, give patients a seat at the table in some organizations, patients are setting the table now, right? They're not just like the, the suddenly the last-minute guest who showed up on Christmas Eve. I think the organizations that are really successful are taking the patient advisory board type activities into consideration early.
They're really plugging them in. And they're seeing the patients as the key members of not only the clinical care team but the clinical development team as well. Right. And I think you can carry that through too when you're talking about key opinion leaders, KOL advisory boards. Well, if it's a clinical trial, sure. You need KOL is involved. They're going to put your name on the conference, presentation, poster, abstract. They're not going to recruit patients. Right. But they may build interest. If it's a global study, they're the only ones that are going to get you sites in Japan, for example, right. You get the, the internationally renowned KOL to reach out there to their colleagues. But you know, often we get KOL input on a protocol or on prescribing practices. And they're saying, I don't know, I'm doing research. And it's an opportunity to talk with the junior partner or the non-KOL who's really in the trenches with patients. So I think we have to get a wider diversity of perspectives and opinions all along the process from patients and clinicians as well.
Aaron
Amen. Amen brother. Thanks so much for your time Richie. This was really great. I'll just quickly tell you my Eagles story and, and we'll let you go. I'm from San Francisco so I grew up a Niner fan and I used to love football until I moved to Boston and spent some time out there. And I grew to hate football because of all the Patriots fans, everyone are there so it's like the worst fan city in, in, in the world I think. And so I was down in New Orleans with a friend of mine to avoid the Super Bowl because the Patriots were in it again. We're at this karaoke bar, cause it was the only bar not really, like, focused on the game and it was a drag karaoke night.
So all these drag queens were out and, like, really dressed up and it was great. And then all of a sudden it seemed like the Patriots might lose to the Eagles and the music stopped. The lights came up and everyone is, like, perched on stools, including the MC to try to, like, to wait for the moment when Tom Brady would actually lose one of these things. And when the Patriots lost it was just like such an, it was like an explosion of happiness in that bar. And I tell you, they, they were dressed so nicely and done up so pretty. And it was just a lot of grunting, all of a sudden, just like the most happy grunting from the drag queens, running the karaoke night at this random New Orleans bar. And that's my last happy football memory.
Richie
You know, Aaron, thank you for sharing that. That was my last happy football memory as well. I traveled home. I flew to Philadelphia from North Carolina to watch the game with my parents. And we went to the home of one of their friends and I was the only one under 70, well, I'll give my parents credit. Let's say the only one under 65 at that point. And as much as I enjoyed watching the game and I cherished that, that memory of watching it with them, I wish there had been more drag queens. It's all I'm saying.
Aaron
Yeah. It definitely makes everything a lot more fun. On, on, on that note, we can call it and thanks so much Richie, this was great. This was awesome.
Richie
Yeah. Thanks so much. Congratulations. You've now gotten the first. Sure thing, Brittany. Congratulations. You've got the first episode under your belt all up from here, right? Woo. Nowhere else to go. Yeah. All right. Take care. Stay safe out there. Bye now. Bye.
