Trials with Maya Z

Maya TrialHub (00:00)
everyone You're again with my with Trials with Maya Z. See I even like change the name So it's not my like best day, but actually it's my one of my best guests actually joining today I've been following that Trafford for quite some time. He is one of the LinkedIn influencers. I have to say even

Ted Trafford (00:13)
Huh?

Maya TrialHub (00:21)
Derk from Castor was asking for Influencers since he was the first one to be named there, so Ted, you're doing a good job there. Ted defines himself on LinkedIn as a clinical trial, clinical research director, strategic advisor, and problem solver. And now I'm putting another label in the stream for Influencers as well. Ted, I'm extremely happy to have you welcome and giving the words to you to introduce yourself for the people that accidentally haven't heard about you.

Ted Trafford (00:28)
No, thank you.

Ha.

thanks, Maya. It's so great to be here today. I am, yeah, I've been working in clinical research for 29 years now. And I've actually spent my entire career with the same company, Probede Medical Research, which I know is a bit of an anomaly in the clinical research industry. But yeah, I started my journey as a research assistant slash study coordinator.

Maya TrialHub (01:09)
It is. Absolutely.

Ted Trafford (01:17)
spent 20 some years as the managing director of the company. And now I focus on business development at Probity Medical Research. And Probity is a clinical trial administrative support company that has a network of 70 clinical trial sites spread across four countries. So I think that is really relevant to our discussion today.

Maya TrialHub (01:36)
Wow.

Yeah, and when you say our discussion, I just wanted to remind the audience that this is actually part of of my mini series on the importance of understanding the standard of care before starting any clinical trial. indeed, thanks for mentioning that you have these 70 countries across four different countries because in core standard of care is actually understanding the country specific standard of care.

And yeah, I'm more than happy to discuss that with you and understand your firsthand experience. But before that, I want to start with the question I asked you just before we started our conversation, which was because it's indeed our first conversation ever. I mean, I've been following you, but it's really our first conversation today. And so I was very curious to understand what is the one thing if because.

pretty sure I know that you're exploring the whole research industry, but if we speak about the one thing that you're most passionate about today when it comes to the research industry, what is this one thing that...

Ted Trafford (02:49)
So that's actually a really difficult question. But when you asked that question, the first thing that popped into my head was the burden that the clinical trial industry is placing on sites in how they design and operate the clinical trials. And then, of course, that burden extends over to the participants as well. But sites are really struggling with

Maya TrialHub (03:14)
Hmm.

Ted Trafford (03:16)
everything that's been offloaded to them and everything that they are now asked to do that hasn't historically been part of what they do in clinical trials. And it's affecting so many aspects of the conduct of those studies as a result.

Maya TrialHub (03:30)
Yeah, I mean, I fully agree with you. I've never been a part of a site. But let's say a couple of years ago, I was very frustrated because I was supporting a few patients to start a screening process with a few sites across Europe. And none of them were replying all of our emails, even though like we provided very

good information, like short information on the patients, their eligibility, like why we believe they can be eligible and so on and so forth, why it's quite urgent. We tried giving them a call. It was very, very difficult. And I was really pissed on sites. I was like, these sites, they're the ones not like helping the industry. And then I had to work with a few sites firsthand with few investigators.

Ted Trafford (04:13)
Hmm.

Maya TrialHub (04:27)
Also, I was in a room full of Kyopini leaders in oncology, I think in Czechia, I was speaking at this event. And I started hearing stories of people who decided to no longer do any clinical trials. So I decided to join their conversation, started asking them why? like, you will be on the front end of research of medicine and you get to offer more options to your patients, tell me. And when they...

actually started giving me stories of what it actually is of conducting a clinical trial from the investigator's perspective. That's just one perspective. Then I was like, okay, there is a whole new universe that I don't understand now. And I started researching and imagine in the States, for example, you have the professional sites that are all they do is research, but in Europe that actually is not that common. I mean, there are professional research sites.

but most of the sites are actually just everyday hospitals and clinics. So that's on top of everything else. So yeah, the burden of sites is definitely something that I'm passionate about. But Ted, I wanted to understand your perspective of the burden and how much do you believe this burden comes from the lack of understanding of the standard of care of the patients, the local specific standard of care.

their patient pathway.

Ted Trafford (05:55)
Yeah, the burden on sites affects so much and so many different aspects. And a big part of it is time. so understanding the patient, I'm gonna call it the patient journey and how standard of care relates to that is, I view standard of care as being,

Maya TrialHub (06:08)
Mm

Ted Trafford (06:25)
the treatments in that particular country, the programs that will be run to support the patient in that particular country for the indication that they are experiencing. But the patient journey, I believe, goes a lot deeper and a lot more in depth than that.

It involves, you know, from the time they first started having symptoms to, you know, finding a physician. In some cases, it's very hard to get seen by a physician in some countries. And sometimes you have to go through many different physicians in order to find one who is going to understand what's going on with you and actually provide a concrete

Maya TrialHub (07:01)
Mmm.

Ted Trafford (07:25)
diagnosis. So that patient journey is many steps along the way. It could involve many different people. And, you know, I think personally, just back on my own experiences with medicine, my mother was struggled for 12 years before she was diagnosed with SLE. And so, you know, that journey

Maya TrialHub (07:48)
wow.

Ted Trafford (07:54)
is burned into my brain. And so how does that then relate to clinical trials? How does that relate to site burden in clinical trials? I remember in the early days when I was very active in the clinical trials at our site, we would spend a lot of time engaging with other physicians who were seeing

patients that had the conditions that we were doing studies for. And we had the luxury of that time because the studies were a lot simpler. And it was part of our recruitment enrollment engagement process. But as the years went on, the studies got much, much more complicated. The

Maya TrialHub (08:30)
from the sponsors and CROs And I've never been in such situations, so I'd love to learn more. What happens if you ask for extra resources for engaging with these doctors?

Ted Trafford (08:45)
the definition of eligible patients got so much more narrow that we just didn't have the time to spend engaging the other physicians or getting out, engaging patient groups because we were just spending so many time on the other things which are always presented to sites as being urgent and important and immediate.

Maya TrialHub (09:12)
Now you just reminded me of the video that you recently shared about the clinical trial marathon and all these obstacles. love that, by the way. I sent it to you. Yeah, I love that. I'm definitely going to share that as a link in the description of this episode. Like you're starting to run and suddenly there are obstacles coming your way. You that's like a normal marathon, but actually you have to do that.

Ted Trafford (09:18)
Hahaha.

thank you.

Maya TrialHub (09:37)
and that, like another jump and so on and so forth. It's a great description actually of exactly what you're saying now. These protocols and all the things that are coming with that. Is it because of lack of resources that you no longer have as a site now, no longer have the time to engage with other doctors? Or is it, I mean, when I say resources, internal resources, but I also mean like, what about if you ask for these resources?

Ted Trafford (09:44)
Yeah.

Maya TrialHub (10:07)
by from the sponsors and seros. And I've never been in such situations. So I'd love to learn more. What happens if you ask for extra resources for engaging with these doctors?

Ted Trafford (10:17)
Yeah, okay, so the pharmaceutical industry's approach to supporting sites on recruitment and enrollment is a really interesting one. So in order to be a site that recruits well for clinical trials, that is really a highly skilled task, highly skilled.

process in order to accomplish identifying potential candidates who are eligible and are interested in the study. And the problem that we experience is the pharmaceutical industry doesn't value that side of or that process, that area for enrollment and recruitment in clinical trials.

Instead, a sponsor will spend a phenomenal amount of money engaging in an advertising agency to help them recruit for a study and won't provide adequate resources to the site to actually pre -screen patients and devise their own recruitment strategies. So

Have you ever watched the show shark tank? Okay. Okay. So in the show, you know, for anybody who hasn't watched it, company owners pitch their company to investors to try and secure investment. And one of the common questions the investor, the investors ask is what's the customer acquisition cost. And they want to know how much the company spends on advertising in order to.

Maya TrialHub (11:47)
yes, I'm a huge fan.

Ted Trafford (12:14)
obtain one customer. And so they use that to measure, you know, the effectiveness of the company and the potential for growth. And so in clinical trials, we know that it's critical to have participants in our studies, but we don't really have a clue what the true participant acquisition cost is. And we don't understand how much it varies by geography. So part of the challenge is that in clinical trials, it's not just a monetary cost, even though it's

treated as such. I use the example of the advertising agency where there's enormous amount of money spent, but the participant acquisition cost is also very much a time component. so, know, advertising is just one piece of the cost. And so time is absolutely critical.

And sites do not have the time to properly recruit, evaluate, pre -screen, study the patient journey themselves. And so as a result, that gets pushed aside as these other competing priorities take place. So the hours and hours and hours that sites spend on training, the time that sites spend dealing with devices or

heck in clinical trials that doesn't work properly. All of that takes away from the ability for them to spend time connecting with potential candidates for clinical trials.

Maya TrialHub (13:51)
that do I understand correctly? What you're saying is that sites no longer have the time to properly understand the candidates so that they can also think where can we engage with these patients? Like where can we find these patients? So they don't have the time to do this analysis on their patient journey. At what stage they get diagnosed, how, who basically do they trust, who's treating them or who's diagnosing them. They no longer have this time.

If that's really the case, are the expectations from the site that the sponsor will provide this information? You're starting the trial, like here is all the information that we've gathered about these patients. Go and conquer the world.

Ted Trafford (14:38)
Well, I think that the sites actually have a fairly good understanding. So the physicians, you know, they have a, I'd say a fairly good understanding of the patient journey. But where the time is lacking is to be able to sit down and actually review that, to talk to patients, to explore, okay, if this is

where the patients are at in their journey, how do we connect and engage with them at that point where they are? And so there's a, there's, it is a big lack of time and just ability to focus on those, those things. And, you know, I, I don't know, actually I was, I was thinking about this, you know, when you reached out and said you wanted to talk and, and I was wondering,

Do you know if there is a patient journey questionnaire that is out there? Because we do a lot of, we complete a lot of questionnaires in clinical research trials. So there's quality of life questionnaires and disease impact questionnaires. But do you know of a patient journey questionnaire that explores how that individual was?

diagnosed, how many different doctors did they go to before they got that diagnosis? How long did it take them to get treatment, et cetera? Who was it that told them they might have the condition that they had?

Maya TrialHub (16:19)
That's a very good question. And that strikes exactly like in the area that I'm most passionate about. Actually there is, there is such a patient journey questionnaire. I wouldn't say it's a standardized thing. Don't get me wrong, but a lot of companies are doing the so -called market research where they go, go out and survey patients. I would say that also advertising companies, like patient recruitment type of companies would also do that.

Ted Trafford (16:28)
Okay.

Okay.

Okay.

Maya TrialHub (16:50)
The problem with these patient questionnaires is that sometimes it's that's so for example with site feasibility, how do you do site feasibility? The best scenario is you go out to all the sites or at least one, two, three per country, for example, to survey them what they think about the protocol. Do they think they have the the patients? Is it feasible? And so on and so forth. And you would do it country by country.

With a lot of these patient questionnaires, you focus on one, two countries max. A lot of these market research companies will just use, let's say, random people that they are working for years and years. And they may be even like expert patients, not the lay patients, which is a huge problem. Because once you're a patient expert, you may remember the early days when you were diagnosed and so on and so forth.

Maybe that's like 15 years ago, but things are changing all the time. And actually people will be super surprised, but the standard of care defining the patient pathway, which is access to treatment, access to diagnosis, timelines for that and so on and so forth, is actually a lot more dynamic than people think, especially nowadays. Because there are 20 ,000 plus clinical trials a year. I probably...

Ted Trafford (18:09)
my goodness, yes.

Maya TrialHub (18:14)
I'm not quoting like, like don't quote me with this number, but it's thousands of clinical trials a year. And yes, I know 90 % will fail. So not many actually gets to approval and to actually reimbursement after that. But there are treatments that are being reimbursed and they're absolutely changing the universe of patients and their, and their patient pathway. And here not only treatments, but also medical devices. So

Unless you actually do a real time type of real world study with patients from the country you're targeting, you can't be sure that you really understand the patient journey. And even one last thing on that, even I would say that even the site surveys are maybe not that timely because usually these surveys get to the sites when you've already done a lot of the work around the protocol.

and a lot of the work around the country selection. And so by the time you're going to the site to ask like for feedback, especially if we think about sites outside of the United States, it's kind of too late. Sometimes, and I completely understand sponsors, don't get me wrong here. Sometimes hearing the truth, especially when you spend so much time and money to get to where you are now and someone telling you this is not gonna work, you're like.

Ted Trafford (19:20)
Yeah, it's too late.

Correct.

Hehehe.

Maya TrialHub (19:38)
But I spoke with this key opinion leader, they told me it's gonna work. You tell me it's not gonna work? Well, no, it's gonna work.

Ted Trafford (19:43)
Yeah. Well, and that's just it. Like, and that's why I brought up the question of the patient journey questionnaires, because why are we not collecting this information in the clinical trial setting so that we can learn? Because some enrollment in some of these studies goes on for a really long time. So why are we not taking the time to understanding the journey of the people that

Maya TrialHub (19:58)
Hmm.

true.

Ted Trafford (20:12)
are participating in the studies so that we can then gain information and make decisions based on data that we're collecting in the studies. So, you know, if I was a sponsor and I was committed to an indication or a therapeutic area, I would want to collect valuable information. And the questionnaires and the surveys that you mentioned,

kind of get the sense that they're more either, either post approval where the pharmaceutical company is trying to understand the journey so they can market the drug rather than in the clinical trial setting. And you mentioned advertisers doing market research, but unfortunately a lot of the advertisers are not doing a very good job with the advertising for clinical trials.

Maya TrialHub (20:58)
faces yeah

Ted Trafford (21:12)
have very few advertising campaigns that are effective anymore for clinical trials. And we either get flooded with respondents who don't meet the criteria and the site is just going through referral after referral after referral and can't find anybody or the pre -screening is too tight and we get no results at all. the

Maya TrialHub (21:17)
and

Hmm. Interesting.

Ted Trafford (21:40)
Yeah, the social media advertising campaigns is a really tough space right now.

Maya TrialHub (21:47)
It is because it's also quite competitive and it's very expensive. Very, very expensive. I I would argue that it's way more expensive to advertise your clinical trial than actually conduct patient focus groups at the very beginning and engage the communities and like maybe even train the sites to do this outreach and connect with the other doctors.

Ted Trafford (21:52)
It is.

Yeah.

Maya TrialHub (22:16)
Yeah, that's definitely a big topic out there. And to me, the advertisement, with one caveat, I believe that advertising does work. I mean, don't know, like now, precisely, maybe something like changed in the past when I was involved with such global patient recruitment. I've seen advertising campaigns working quite well. But I also have a feeling that these advertising campaigns are seen like the pill, you know?

we human beings, we're looking for the shortcuts, always. So it's same with these patient recruitment campaigns. That's a shortcut. Like you have challenges, what do you do? You find the shortcut, like you go to the campaigns, only to understand that this shortcut comes with other minuses and other side effects. And these side effects are more budget, more time, and not always spent with the right results.

Ted Trafford (22:48)
Yeah.

Well, and it's also a very US centric approach to advertising. you know, for these big phase three studies, we might have a lack of country specific websites set up for the studies. So it might be applied. So for example, for all the English speaking countries, they might have just one website and

Maya TrialHub (23:27)
Hmm.

Yeah.

Ted Trafford (23:37)
The challenge with that is there are nuances to things like that. And just to give you a specific example, in Australia, if you have the AU designation on your website, it tells the person that's on the website that this is an Australia based website. So, whereas if they're just going to a dot com website out of the US,

Maya TrialHub (24:00)
Mm

Ted Trafford (24:05)
then I think it can affect the confidence of the person who's based in Australia because, is this actually something local that's going on? And so it can affect confidence and trust. And I think there's a lot of advertising companies that don't understand these little nuances sometimes.

Maya TrialHub (24:29)
Yeah. And without understanding the patient journey, and I want to add actually something here, I do agree with you that there is a difference between standard of care and let's say patient pathway. These are all the same because it's defined by the access to treatment, access to healthcare in general. But then the patient journey is the perception of the patients. It's how you live this through all this patient pathway, how you experience the local standard of care. So depending on what's the healthcare,

Ted Trafford (24:47)
Correct.

Right.

Maya TrialHub (24:59)
environment, you may trust the system or the other way around. And this also contributes to the clinical research. Let's say results or lack of results, patient recruitment results or lack of results. So without understanding this patient journey, you're making assumptions and you're even doing campaigns and like projects.

Ted Trafford (25:03)
Yeah.

Maya TrialHub (25:23)
but not targeting these people the right way without our targeting them with their needs and with their, let's say what they want to hear and what they can, let's say relate to. that...

As one last question on my end, if you have to summarize, what is the implication, like from your perspective, what is the implication of not considering the patient journey before starting the clinical trial? What would that be? Maybe one or many implications from your perspective, from your experience.

Ted Trafford (25:57)
Yeah, so I think that there's the obvious things we could talk about. So we could talk about how it affects negatively affects enrollment and the whole enrollment period in clinical trials where it affects the ability to get the studies done on time or we could talk about retention or things like that. But one of things I wanted to throw at you was how it affects the investigator confidence.

Maya TrialHub (26:26)
Mmm.

Ted Trafford (26:26)
And so when a physician is participating in a clinical trial and they're doing the clinical trial and they're really excited and interested in this clinical trial, but there are things designed into the clinical trial that are preventing patients who really should be eligible, but aren't for one reason or another. It affects their confidence in not only the clinical trial,

but also the sponsor that's running the study. Because I think the thought process goes to, well, sponsor really doesn't understand these patients. And so ultimately at the end of the day, when a pharmaceutical company has the aim to sell a medication, the last thing you need is an investigator, a physician that doesn't have confidence in the company and believes that the company doesn't really understand the patients that...

have the condition being studied. And because we know that investigators, once a drug is approved, they're most likely to prescribe that medication because they're comfortable with it. They've had experience with it. But if that physician doesn't have confidence in the pharmaceutical company that's manufacturing the drug, it's going to affect sales at the end of the day.

Maya TrialHub (27:39)
Hmm.

Yep, you're so right. And honestly, the confidence of the investigator was not something that I was thinking beforehand. So that thank you so much for spending your time with me today and sharing actually this with me because yeah, it's another perspective of why understanding the patient journey is so important. And I've never thought of the investigator confidence and never thought beyond clinical trial, but you gave us a very big picture understanding why. Thank you so much.

Ted Trafford (28:06)
my pleasure.

thank you so much for having me. was so much fun, Maya