Trials with Maya Z

Maya TrialHub (00:01)
Hello everyone, this is Maya with Trials with Maya Z and today I'm with Orit Rinder, a clinical research expert, a patient advocate as well. Orit actually found me on LinkedIn some like months ago or weeks ago. We started this interesting conversation around my like interesting topics, standard of care. And she actually told me some really interesting stories that I thought.

We should share with the rest of you. So, all right, first of all, welcome and please introduce yourself.

Orit Rindner (00:34)
Thank you, Maya. Thank you for inviting me. My name is Orit Rinder. And as Maya said, I'm into clinical research for many years. I started my medical background in working for the medical center.

And I worked there for a few years. then somehow during COVID started, and I got involved with a clinical research company. And I did a trial there. And I really liked it. And meanwhile, between the medical center and the clinical research, I opened up an NGO for a rare disease, for Gordon syndrome. So I was very involved in that. And I was invited to different places to speak, different conferences.

And now for the past two years, I've been working also on clinical trials. And yeah, I love it.

Maya TrialHub (01:18)
Very interesting. One of the things that really struck me was the fact that you combine the patient -advocate expertise with the clinical research expertise. And I wonder, like, when you're working on a daily basis in clinical research, but at the same time, you're working on this NGO. So.

Have you been in the situation to compare these both different worlds? Are they actually different worlds in the first time?

Orit Rindner (01:50)
It's totally different world. Patient is face to face and clinical research, see numbers and you see Excel charts or CRMs. And it's different. I like the one on one. I like talking to people, like helping people. I found that out when I worked at the medical center that I was the first point, the first target, first point of a meeting when the patient came to the clinic, they were talking to me first. I was like there in quotes, I was their babysitter.

Maya TrialHub (01:56)
Yeah.

Hmm.

Orit Rindner (02:18)
So that's what I liked about the patient advocacy. I like helping, I like seeing the outcome. And the clinical research, of course, is having a good outcome for the patients, trying to find something that will help them.

Maya TrialHub (02:27)
Yeah. Yeah. Do you think that your patient advocacy activity helped you in any way to conduct clinical research much better, like to impact clinical trials much, more?

Orit Rindner (02:40)
Yes, I saw it from the other side of the table.

Maya TrialHub (02:43)
Yeah. Any examples like on top of your head?

Orit Rindner (02:48)
I know of a person that she needs a medicine for, she has the disease, she has Gordon syndrome, and in the States the medicine that they take is very, expensive. It gets to like $15 ,000 a month. And if she does the clinical trial, she doesn't have to pay anything, she gets it free. But she volunteered for the clinical research for it to be in the trial, and for four years she had free medicine.

Maya TrialHub (03:07)
Yeah.

Orit Rindner (03:15)
She went every month and they did her checkups and they gave her her bottle of medicine. It's like a chemo based pill. And that's the only way she could pay. Otherwise, I mean, she works in a drug store. She can't afford $15 ,000 a month.

Maya TrialHub (03:21)
Hmm.

the video.

So from what I understand, from your perspective, clinical trials is another opportunity for patients. Is that the way you see clinical trials?

Orit Rindner (03:40)
Definitely, definitely. helps them because especially in certain countries, certain countries, they get it for free, the medicine. Like European countries, when you have national health, then you can get it for free. But when you're in America and you don't have health insurance.

Maya TrialHub (03:46)
Mmm.

And that motivates patients to join more in clinical trials. Actually, that was the thing that really started the conversation between you and me, the fact that this local standard of care really defines in one way or another whether patients will be more willing or less willing to join a clinical trial. this example is exactly that. If you don't have access to another alternative, then you're more willing to join a clinical trial. In this case, that was in the States

But sometimes that's not the case. And if, for example, you have another alternative through standard of care, then you are less motivated to join a clinical trial. So it's very interesting to see how the different country realities also influence the clinical trials outcomes. Very interesting. Do you think a clinical trial's, I mean, how much clinical trials are aligned with the patient's expectations and their reality?

Orit Rindner (04:49)
How much, can you repeat the question?

Maya TrialHub (04:51)
Yeah, sure. So how much do you think clinical trials are aligned with patients' reality, their needs and expectations?

Orit Rindner (04:59)
I think they're getting better, but I do think the people that doing the clinical trials have to get to know the other side, have to get to know the patients. I know there was a clinical trial from the Gordon syndrome disease in London last year for like six months. And I know patients were brought from all over. They were brought from Italy. They were trying to get a lot of people to come. And some of them couldn't come on some of the times. It was either a holiday or they had a wedding or their job wouldn't let them go or.

Maya TrialHub (05:06)
Thank

No,

Orit Rindner (05:29)
all kinds of excuses, know, not excuses, but life, and life was happening. Yeah, the clinical trial side has to think more patient side, as it is having a hard life. So.

Maya TrialHub (05:30)
Mm.

Like real life,

And you as being a patient advocate, have you ever consulted the company on how they should design their trial, their schedule? What's your experience with that?

Orit Rindner (05:53)
Yeah, sure. The one I did in England, they wanted some feedback. They asked for feedback. Very, very intense feedback. I was quite shocked, actually. It was really nice. It was a good feeling. It was a big company, a big pharmaceutical company, and they actually invited me to talk on a roundtable type of thing, in Zoom, you online.

Maya TrialHub (05:58)
Yeah.

Mm

Orit Rindner (06:16)
But what should be better, how should we better it, and what else can we do? So I do think that the clinical research companies do have to ask the patients what can they do to help them. Because as it is, they're visiting doctors every week, every month, whenever. And their life isn't as easy it is for somebody who's never been to a doctor.

Maya TrialHub (06:37)
Hmm. And do you think that by participating in these roundtables, did it have any impact on the clinical trial at the end?

Orit Rindner (06:47)
Yeah, I think so. Things have changed, definitely changed. It takes time, but it definitely changed. Yeah. I can feel it when I go to conferences and people talk to me. I can definitely feel it.

Maya TrialHub (06:56)
That's interesting. And at what stage do companies engage with people like you to provide feedback?

Orit Rindner (07:06)
Right now there is a new trial that's coming out and I was called, the NGO was called if we have patients that would be willing.

Maya TrialHub (07:12)
Mm -hmm. -huh. Mm -hmm.

Orit Rindner (07:15)
particular patients, they're a tired of not having clinical trials. It's a hard disease. It's a hard disease for them. And it's hard. It's really, really hard to get them to come. I have a hospital up north in Israel. They said, you don't even have to do an appointment. Just come. Just give me your phone number, your name, and just turn up. They're asking for a maxofacial to check the teeth, because that's part of the disease. And I've only been able to get like five, six people. And there's like 300 people.

And people say, it's too far. I don't want to go up north. And now with the problem of the war, it's even worse. Nobody wants to go up north because that's where the war is. So that's another problem. You have all kinds of problems.

Maya TrialHub (07:53)
yeah.

But at the same time, like last time you told me about this story where a patient had to travel actually to the States actually to participate in clinical trial and the company was ready to pay for that.

Orit Rindner (08:06)
Right.

Yes, so that company was absolutely amazing. We had a patient that she was invited to a clinical trial in Chicago and they flew her in every 30 days. mean, just the flights and the hotels were at least $5 ,000 a month. And that's something that obviously a normal patient cannot afford to do, the average person. But they really made an effort. And if I'm not mistaken, they must have had about 150 people on this trial.

Maya TrialHub (08:22)
Hmm.

Yeah, of course.

wow.

Orit Rindner (08:36)
So it was a good number for a trial. And the medicine's on the market now. And the medicine is working. So that's worth it. But the medicine's very expensive. Again, if you live in the States, you can't afford that medicine. But if you're living in Israel or in Europe or anywhere that has national health, you can afford it. Exactly. The country, it's subsidized by the country.

Maya TrialHub (08:38)
Yeah.

No, that's great news.

because it's already reimbursed.

How come it's not reimbursed in the States? I I know there is no national coverage, but then you have the insurance companies. So if you're insured by like any of the companies, for example, wouldn't they cover for this treatment?

Orit Rindner (09:16)
Some of them do. Some of them do have reimburse, but a lot of them, they don't match the exact criteria that's written on the piece of paper. If you're not 49 and a half years old or something, I'm just making up numbers. If you don't have one gray hair, then you can't do the trial. It's like, I'm just making, you but that's.

Maya TrialHub (09:27)
Yeah.

So it's not only the crazy eligibility criteria in the clinical trial, also the same eligibility criteria for being reimbursed for treatment.

Orit Rindner (09:42)
Exactly, we're getting it subsidized or reimbursed. I know I have friends that are with the syndrome and they are getting reimbursed. But you always have a few that aren't getting reimbursed or can't even afford to do it even if they're not getting reimbursed.

Maya TrialHub (09:50)
Hmm.

Yeah.

Hmm, very interesting. What's the motivation of such a patient to actually travel like so many miles every single month, especially having a disease? Like why would this patient do it?

Orit Rindner (10:11)
They're tired. First of all, the Gordon syndrome disease is a multiple organ disease. It's not just one doctor. You're going to a dentist, you're going to the heart doctor, you're going to the neurologist, you're going to the gynecologist if you're a woman, you're going to the ophthalmologist, you're going to a neurosurgeon. It's a whole list on this particular disease. And it's tiring. And if there's something that can help a little bit, then why not?

Maya TrialHub (10:15)
Yeah.

Okay.

Yeah. But would the clinical in this case, would the clinical trial offer this multidisciplinary kind of management and control or they're just tackling one particular thing? So you have, yeah. So, so basically the patient still has to do all these doctor visits. And I guess that this, this is something that the company should expect that it's not going to be the trial burden and all this travel.

Orit Rindner (10:50)
one part because just the skin part that's it like skin cancer.

yeah.

Maya TrialHub (11:07)
but they're still the same burden of going to these different doctors. That's actually a very good point that sometimes we forget that disease comes with other comorbidities and other side effects. And they require other type of management. Extra time spent on that extra, let's say, medications as well. And also when you have a family, it makes it even more complicated.

Orit Rindner (11:11)
Right, right.

Right.

Exactly. If you're married with your kids or a husband or a wife or, even to get, to get onto that trial, because it has so many co problems, like you have to go through all the, the, the medical questions. Like the questionnaire she showed me, was like, it was, it was like a huge, the questionnaire book was, because they ask you on neurology on, you know, ophthalmology on gynecology. They ask you on all this, all the organs. They ask you questions.

Maya TrialHub (11:54)
Hmm.

Yeah, interesting. I wonder because you've been working with also the hospitals in a clinical trial, but also you provided an advice as a patient advocate. Do you think that, I mean, how different is the advice that an investigator can provide to a company for the clinical trial compared to the patient advocate's advice?

Orit Rindner (12:27)
The patient knows the disease. Definitely knows the disease.

Maya TrialHub (12:30)
So you don't think that investigator will give the same advice? Like if, for example,

Orit Rindner (12:33)
Only if he knows it, only if knows it. And all investigators know all that, all that. So that's why I think they should talk to more patients. That's definitely the reasoning for it, talk to patients or to have these round tables before they start the clinical trial.

Maya TrialHub (12:39)
Mm -hmm.

But in.

in a disease that you're operating in, wouldn't doctors actually be like really experts in this disease and know it all? No? Okay.

Orit Rindner (12:57)
No, because it's a rare disease. That's another problem. It's a rare disease and getting also getting in national health, getting subsidized for a rare disease. That's a whole nother podcast.

Maya TrialHub (13:11)
Yeah, yeah, I can imagine. And also you mentioned that it's a multidisciplinary type of management of this disease. So not every doctor would know actually what happens with these type of patients. That's very, very interesting. What are the top types of advice that you provide to a pharma company when they're trying to think about their next clinical trial in this disease?

Orit Rindner (13:38)
The obvious is to see how many people have the disease and also how many patients there are. If the infrastructure is good enough to do the actual trial, like now this new company that's going to start this next trial, they're scared that in Israel there's not going be enough infrastructure and not enough patients because it's a small country. So they keep asking me how many people they have. It doesn't matter how many people they have, how many people are willing to do the trial.

Maya TrialHub (13:50)
Okay.

Mm -hmm.

Yeah, exactly. Yeah, that's very good point. It's not only how many people there are, but how many people will be willing to join this trial. And then that will depend on, actually, what would depend on? For example, if this company decides to go in Israel, let's say that they decide there are enough patients in Israel, why would patients join in this clinical trial? And also, why would patients not join this clinical trial?

Orit Rindner (14:14)
Lighting.

One, they can't be bothered or they're scared. What is this? They're testing me. I'm sorry, everything's beeping here. Everybody, what do you call it when they test on pigs? What am I, a guinea pig? That's the first question. When I talk to my patients, that's the first and always, always, what am I, guinea pig? What do mean it's a clinical trial? Because I offered the dentist up.

Maya TrialHub (14:44)
like guinea

Orit Rindner (14:55)
the maxofacial up north. She's like, just send them already. Send them. I'm doing everything. It's free. We'll even give them the transport. We'll give them anything you want. They don't have to wait in line for the appointments because I hate waiting in line for appointments. They have to wait for appointments all week long. And they're all scared. What are they going to do to us? What are they going to do? Are they going to take your x -ray? They're going to check your teeth? You don't have to explain to them. And some of them are really fearful because they've been to so many doctors that didn't know what was going on.

Maya TrialHub (14:57)
Yeah.

them.

Yeah.

Orit Rindner (15:23)
I have one patient, went to a gynecologist a few years ago. She came to me crying, hysterical. She walked in and she said to them, I have Gordon syndrome. And the doctor says, okay, we'll take out your uterus. Okay. 19 years old. Okay. We'll take out your uterus. No questions asked. No, no history. She didn't even, he didn't even, she didn't even sit in the seat yet in the clinic. told me. And,

Maya TrialHub (15:38)
wow.

Hmm. Wow.

Orit Rindner (15:53)
That's what happens when they don't have the knowledge about it. Or they heard something about this disease. You have to take the uterus out, but you don't. If you take care of yourself, you don't.

Maya TrialHub (15:56)
Yeah. Very interesting.

Yeah. Speaking about Israel and clinical research, any observations of what happened like with Israel and clinical research now during these times? They are tough. Yeah.

Orit Rindner (16:12)
Very tough. We don't have doctors. All the doctors, either they're out in the field in the war or...

If they're not in the war, they're going abroad to do programs and studies and whatnot. And it was actually on the news a couple of nights ago, the head of the Tel Aviv Medical Center was talking, we have a big problem. Half my doctors are not here in the hospital. They're out and we have two wars going on. We have one in the North, one in the South. Half the doctors in the South, half the doctors in the North, not all the doctors, but a huge percentage.

Maya TrialHub (16:26)
Yeah.

Yeah.

How is this impacting patients?

Orit Rindner (16:50)
bad. can't get, you can't get, I have, I think I have something wrong with my rotors and I hit my shoulder and I asked for an orthopedic doctor. They give me an appointment in November. I said we're in September, you know, she's in, so the woman said you're lucky if he turns up in November. So that's, it's impacting very bad. It's never, usually we have, we have one of the top medical centers in the world. Israel for medical is amazing.

Maya TrialHub (17:08)
Wow. Yeah.

Orit Rindner (17:18)
Really amazing. Averages.

Maya TrialHub (17:20)
And coverage as well. mean, we've been working on global standard of care assessments and Israel is always one of the top countries, like, reimbursing all of the even more expensive type of treatments. So coverage is amazing.

Orit Rindner (17:28)
it.

Nothing. paid like maybe $20 a month, maybe. And I get everything. Anything, even dentistry, everything. It's amazing. People don't realize it. think the whole Middle East, my God, you know, but it's not that way. I actually have a Bulgarian patient called me three days ago and asking if I could help her with the medical. I said, you really want to come? You know, there's a warrant. goes, I don't care. heard Israel is the best. My mother has a heart problem. Can you please find out for me? I'm like...

Maya TrialHub (17:41)
Yeah, that's a great other title for the country.

Well.

Yeah, I have.

Yeah.

Orit Rindner (18:04)
Yeah, sure. Only no patient from when I worked in the medical center.

Maya TrialHub (18:05)
Yeah.

Yeah, there are like, for example, in our, like, with my team, we've been working on a platform supporting patients like to find clinical trials, especially when it comes to fertility, like these are the some of the best centers, like the most work being done in Israel. So I really hope, I really hope that things will get better. And doctors will go back, will come back. And hopefully things will really improve and

Or thank you so much for sharing all of these stories and being so transparent. Hopefully, again, we'll continue another time with even more stories, even more positive light, with more research in Israel. And please take care.

Orit Rindner (18:38)
Thank you.

I hope so.

Thank you very much, Maya.