Trials with Maya Z

Hello everyone and welcome again to Trials with Maya Z. Today I am with, uh, my new friend Duncan Shaw, who, um, is leading DTS, a company involved with translations in the clinical research industry. Duncan, why don't you share with us a little bit more about yourself?

Well, thank you very much for having me today, Maya. I'm really honored to be on your show and really inspired by the work that you're doing. I wanna encourage you to keep doing that and, uh, to further your mission. yes, I have been in the clinical trials translation space and language translation for over 20 years now, and I've seen the good, the bad, and the ugly massive changes going on all of the time as we are.

Seeing in every facet of clinical trials. And so sometimes the more things change, the more they stay the same. Yet there are ongoing, subtle changes happening and it's very exciting stuff going on. So, uh, really pleased about the past, present, and what the future holds.

Yeah, I'm very excited as well. But, um, what excited me when, when we actually, when we met Duncan, was not so much, uh, What are the changes in the industry, though? We are, we are gonna touch upon that as well, but I, I had no idea when, when we had our first conversation, I was really thinking that we'll speak a lot about translations and, uh, some trends there.

Uh, and I had no idea how valuable our conversation will be for, uh, me. When it comes to my understanding of informed consent, when I decided to invite you to Trials with Maya Z, one of the first things I wanted to bring, and, and discuss is exactly how you see informed consent. Please share that not just with me, but with everyone else.

Well, I think that of course, the mission and purpose behind informed consent is advocating patient rights, and clarifying certain confidentiality and disclosure issues. What's going to happen, essentially, who's going to do what to whom? It's a legalistic layout of exactly that structure, like the architect of a house.

And so it should be to assuage patients who might be on the fence about signing up for a consent form and, and staying in it. Hopefully, from our viewpoint as translators, we have to have a very conservative approach to translating consent forms, and oftentimes this is not award-winning English award-winning content in any source language, let's face it.

And a lot of the time, If we're being realistic, these are legal documents that protect the interests of big pharma as much as they are patient protection documents. Hopefully, there's a marriage between the two, but our job is to mirror the tonality and the content, and the exactness and the tenor of a consent form.

Because you don't want to impart judgment. You don't want to change the chemistry of what it's saying because we think that it should say a certain thing to help the patient. That's the biggest no-no. Translators sometimes fall into that trap that we can't make. So if the source content of a consent form is written very structured in a very legalistic, very technical way then the language register in Spanish and Japanese, Russian, Chinese, and Bulgarian.

Has to be the same.

Mm. Yeah. Speaking about informed consent, uh, what really surprised me is that something that we take for granted, basically it's so, so important. And I remember last time we were speaking about diversity and inclusion and you know, like, or right now, especially in the state, this is a big, big topic and everyone thinks how do we diversity?

By our clinical trials. Um, and I heard from friends working at sites that sometimes, um, they don't even have, uh, informed consent in a, in a language that they're supposed to bring these patients, let's say. with Latin American, uh, origin, but still don't have like, have it in the language.

And I would ask you, I would go even beyond how open are companies or sponsors and clinic research organizations to actually customize the informed consent to address the difference between different patients. Different Ethnicities and different groups of patients.

So a lot of this is going to come down to walking the talk and the culture and values of the sponsoring organization of the CROs behind it, of the IRBs of the big players. A lot of what's moving the hinges here are the big-money organizations, and so the buzzwords and the brochures might talk about diversity in the patient experience and inclusion.

Are they walking the talk? So are they going to customize the experience for a patient? I think there is a problem with trust in clinical

trials from the patient perspective, that's an open secret that's not going out on a limb, and that's why recruitment numbers have been suffering. That's why retention numbers have been suffering.

And so when. Documentation in a, uh, clinical trial, a consent form, patient recruitment materials, other content is in the local language of a patient who's already nervous, to begin with, and this already might be one of their last gasp hopes. Let's face it, the trust factor goes way up, especially if it's an effectively translated document.

And that might mean the difference between them deciding to be a part of the trial and staying in it like I was saying. So it really depends on, is a sponsor organization not only going to talk about diversity and inclusion and customizing a consent form for that patient experience but are they going to do it?

Are they going to spend the money?

Yeah, but, and, um, we are speaking about translation into the local language. But I think last time you mentioned that it's required more than just translating, the person who does a translation, uh, translation, uh, he or she would understand also the culture or this specifics, uh, that are beyond the translation.

So our companies doing this extra step to make sure that people reading the materials, the informed consent, or any patient materials are actually welcomed.

Yes, they, they have to feel welcomed. A problem in the translation of consent forms and in clinical trials like I was alluding to earlier, are translators playing language? God. So they're saying, well, I know what this poor medical writer was trying to say, but I'm going to say it better in German. We're going to reverse

the adverse effect bullet points here because I feel this is more effective.

This is what they should have said. I'm going to explain in Canadian French what these acronyms mean even though English doesn't explain what the acronyms mean. I'm going to help the Haitian Creole patient. So I'm all in favor of helping people. I'm all in favor of helping, uh, build trust and inclusion, but there are limits and there are safeguards in place for good reason.

Do you play tennis by any chance? I'm gonna just throw that out there. You do.

Yes. A little bit. Yeah.

Okay. Well, if we're playing a friendly game of tennis in the park, we're probably not going to call Footfalls on each other. Where you're serving over the line, right? Depends on how competitive you are. Maybe that's true. If we're not going to call foot faults on each other in tennis, what's to stop you or me from marching right up to the net and pounding the ball over the net?

So if we're going to allow a little bit of leeway and translating consent forms, then not exactly what the English say. Well, that's a real slippery slope is my point. What's to stop the translator from materially altering the consent of a consent form in another language on the premise that nobody's really going to know, the CRO isn't gonna read this.

They're just looking for an initial and a signature to move the trial forward. And I'm really gonna make a difference in helping people. That becomes crossing the boundary between translation and editing and decision-making of content, and that's how trials can get canceled. That's how harm can befall patients or possible death.

All manner of bad things that we don't want. So I agree with you that there has to be customization of consent forms. There has to be a certain welcome on board. Culturally, it's more than just words. Yes. You can't Translate word for word what it's saying, but you have to really understand the translator's convention and philosophy.

If you don't ask those questions. I'm speaking to organizations out there, any buyer of translations in the clinical trial process, to clarify what their translation approach is. If you don't have clarity, you're gonna get what you get.

We're getting back to communication and transparency, but let me first summarize, if I understand correctly, um, you as a translation expert, let's say, in like you're and your team, um, you are in the role of balancing how much to, uh, like create the content so that it's. It's customized to kind of like address the differences between cultures, languages, um, and perspectives, but also what will be accepted and compliant to make sure that at the end of the day all the parties are in a safe, balanced space so that they can work together.

That is right. And. When we talk about consideration of participating in a trial, to begin with, when we talk about the translation of patient recruitment materials and documents, let's say website, landing pages, all of that kind of thing, you can't approach the translation of that for a patient internationally, the way you approach the translation of a list of chemical compounds, you can't be that literal and woody.

There has to be a certain cultural flare, a certain marketing, uh, flare in addition to exactly what the verbiage says. And one of the hot topics today, of course, is AI and translation. A lot of the public thinks, oh, these guys are just running this through Google Translate. A lot of automated translations.

Anyway, that's all they're doing, right? And that's not true. But I understand where those, uh, ideas come from. And there are consultants that say AI will never replace human translators because machines are unable to capture the nuance that comes from each language as different ch grammatical rules, semantics, syntax, and context.

And I agree with that fully. So there's magic in translation. There's magic in how you create and craft documentation in your messaging, whether it's social media posts and articles and website articles. There's magic in reaching someone and you can't reach all the people all the time. But we're trying to cast as wide and as effective a net as possible.

So there has to be, as you say, a balance between capturing the content and making it defensible legally. In the event of audits and other inquiries and so forth, and in the events of when adverse things happen, bad things happen, what went wrong, who did what to whom. But there also has to be that balance between making it effective culturally so that someone instinctively feels trust when we read translations.

And you're multilingual yourself. I know for a fact that you've seen very bad translations. I hear this all of the time. How does that impact your trust in the company? Behind that organization behind purchasing their product or service. We might say, well, not that much because it was a low mission-critical document.

No, that's not true. On a subconscious level, we think twice about getting in with that party or company, or clinical trial.

So there has to be that magic of it being culturally welcoming and saying, aha, I get this. This person gets me. Let's do this.

Speaking about, um, these patient materials, uh, many years in the industry, I think you mentioned more than 20 years being in clinical research and translations. Uh, you must have seen so many different documents and patient materials and all sorts of materials. So can you share with us what are these best practices that you've seen now working best, like things that you've seen? Maybe not, not just content, but even visuals, and even formats, which are these best practices and examples that you can share with my audience here?

Well, the content should be kept as simple as possible. A lot of clinical writers tend to be very elongated,

very long, complex sentences in the US and I think elsewhere. The translation is an afterthought. Content is not written with translation in mind, to begin with, so it's always best if content can be kept simplified as much as possible.

Shorter sentences are going to lead to fewer misreadings of the source language, whether it's English or whatever the source language is. It happens all of the time. The more complex a sentence is a paragraph. a section of HIPAA or other contents that there are misreadings of the nuance that result in massive translation differences.

And the end result. So I think that's the biggest key. As far as other best practices go, you can't over-communicate enough in terms of clarity of when you need the translation and what you're trying to do with the translation, to begin with. Most of the time we get, well, we need the translation by next Tuesday to consent a patient in France or Switzerland or Chicago.

That's it. That's all I know. That's not enough. If you really want the translation to be effective. Then the translator should have some understanding organization of what you're trying to do. How are you trying to move the needle in the trial?

And if a junior person is tasked with getting translations, they might not know or be privy to those details, then again, you're gonna get what you get with that Spanish translation or other translation.

Yeah, you're just gonna get the, like, the pure translation without the nuances that you actually need to build this trust layer, that you mentioned. And all these materials, these, these contents, uh, no matter if it's a document or just supportive materials, they're there to serve as a. As a connection even because as a patient you don't see the sponsor, you don't see this link research organization behind the whole organization, and that's your only piece of information.

Plus the doctor and the study coordinator, the people that you see at the, at the hospital that. Not always have the time to spend a lot of time and, and talking you through all of these things. So this piece of paper suddenly becomes the only thing, the only connection that you have, um, with the company behind the clinical trial.

So making sure that this piece of content is. It's correctly done and speaks about the vision and the whys. Like, like Simon Sinek says, what, start with why is important. So yeah, I can imagine. But I, I other side and, uh, like asking for a translation without actually giving most explanation.

So thanks for, thanks for this recommendation. You know, yesterday, uh, I had, um, another episode with, um, Uh, uh, a c e o of one of, uh, one clinical research organization, and he was speaking about this transparency in open communication between sponsors and clinical research organizations and how important this is.

Uh, and now I see it's not just between the zero and the sponsor, but it's across all vendors. So can you share with us any probably positive story of working with a sponsor where you felt that you were really partnering in their project?

Yes, we've had the benefit and position of. Watching the landscape and being a part of it between sponsors, CRO IRB sites, all of the organizations,

biotech, medical labeling, and we've had all manner of experiences. And again, to the degree that there's less siloing and more openness and more transparency, be very direct about the stakes, the stakeholders.

What's at stake here? What are the deadlines? What are the milestones? Budgets and time are limited factors, so if you aren't clear about what you're trying to do by when and what's at stake, then there's going to be ambiguity. And as you know, this is what leads to delays in cancellations, enrollment, and in trials.

So the sponsor-positive stories that we've had are ones where managers are very open and direct with the appropriate confidentiality. Instruments built in, of course, about what went wrong and how they dropped the ball. I think that that's what builds trust too. When you say, we made a mistake here.

We shouldn't have done this.

Does this happen often? Duncan?

No, but, and because it doesn't happen often, you almost like, your jaw hits the floor. You know when the large organization says We screwed up here. And I think those are opportunities to build trust. When we say, I made a mistake, I'm sorry. Instead of hiding behind corporate veneer or finger-pointing and saying, we made a mistake in judgment here.

We should have given you these, these details. We did this well, but we didn't do that so well. That leads the other party to say, you know what, it takes two to tango. We could have done this better. We could have asked these questions, we could have probed more. So when you have that

kind of give and take, It really leads to translations that are not only more effective but on time.

Hmm.

And again,

because if we know, you know, buyers don't care about the darn drill and the features of the drill. They care about the hole in the wall as the old marketing story goes. So what is your hole in the wall and what are you trying to do? How large a hole do you need and why? translators wanna talk about language and linguistic issues in the new Brazilian, Portuguese.

Grammar, grammar, rules, changes. Sponsors don't care about that.

They want to try to consent a pa, a Portuguese patient within the timeframe who meets the inclusion criteria. This is their language. This is their world. You've gotta buy into their stresses. We've each got to buy into each other's stresses in order to

really have that empathy.

That's a big thing that's missing, isn't it? Don't you agree? If you have inter-organization empathy and empathy on a micro basis, I

talked earlier about our motto being every word counts and every person matters. That kind of flies in the face of the big data

world that we live in, but everything that we do matters.

How you do anything is how you do everything. And so when we

move slower, When we move slower and take a deep breath, we actually move faster in the end. That's the best advice and the best success stories that I can think of. When those things happen, things go well. They go on time. Everybody's happy

when they don't.

me about, yeah, which reminds me about some of our, uh, some of my last episodes. It keeps repeating. Preparation is key. Communication is key. So I started feeling that what makes or breaks clinical trials is exactly this lack of communication because there are so many stakeholders. I remember someone telling me that a clinical operations director leading one clinical trial may end up working with 30, even 40 different vendors for one particular clinical trial.

So imagine the number of vendors that you have to manage, if you are not, uh, precise and like not open to all these vendors, and if you don't manage to also, um, create this communication between them, then I would imagine that, that that's a formula of, of a catastrophe.

Well, you know, my, uh, job though. It is hard, and I wanna tell you that I think a lot of people like to throw stones at sponsors in large organizations and

big box enterprise players, and often for a good reason. I'm not saying that there isn't good reason involved, but a lot of those same stone throwers early on later become those same executives and managers later in their career, and they say all of a sudden, oh, this isn't so easy.

It is hard to make hard decisions, and when you are working with 30 or 40 or 50 different vendors, all of a sudden it's not so easy and all of a sudden adequate is sufficient because it has to be. So, a mistake that I've made that DTS has made that translators make when I talk about empathy is a lack of real understanding and recognizing that they are working with dozens of vendors.

That translation's important, but not that important. There's so much juggling and as I say, budgets are limited, time is limited. We're all pulling on the same side of the rope here, but empathy is a two-way street. So you've gotta understand the sponsor side and the CRO side, and yeah, they're not perfect either.

Nobody's perfect. Perfection doesn't exist. But if we're open and admit to our faults as well as. The things that do go well and we give credit to one another, then you're again pulling on the same side of the rope hopefully, and sometimes that friction and that task tension is what gets you to the next higher level.

It doesn't have to be lollipops and roses all the time, and in fact, it's not. Right.

Yeah. Yeah, Um, Duncan, uh, I need to ask you, it's because. Uh, oi oi care. And the reason why I started the podcast in the first place is exactly to discuss these things that make or break a clinical trial. And every one of us, of course, have, it's not one thing, obviously, but I want to hear from your perspective, this is, which is this one thing that makes or breaks a clinical trial from your perspective,

yeah, I, I would like to speak a little bit more macro, if I might on this because I think it directly affects the success of clinical trials. I think around the year 2000, I use that loosely. The US certainly, and other countries I think. But definitely, the US lost its focus on innovation and risk-taking.

And a lot of drug companies acquired other companies and CROs for their pipelines. We all know this because of shareholder return and ROI. That became the mantra that became a big, big shift. Instead of risk-taking and failures financially, it became about ROI and shareholder value. And I think that dramatically impacted clinical trials, make or break success.

When there was an overemphasis on the financial side on not only profits from a given trial but trying to make up for losses from decades ago. So I think this loss, that this risk aversion, we talk about risk mitigation and clinical trials all of the time, but this massive risk aversion to innovation and trying and failing, ultimately that's the best defense risk.

But we're very risk-averse in clinical trials. So I think that on a macro basis, has really hurt clinical trials, this stodgy conservativeness, and resistance to change. This is how we've always done it. So, uh, we have to be open to ai. We happen to be, have to be open to new ways of doing things. We have to be open to D C T.

And maybe what comes out on the other side isn't exactly what we imagined. It rarely is in life, but we have to be less change resistant, which isn't, which is easier said than done. I fully admit it.

Of course, of course. It's always like that. But if we don't, uh, if we don't, let's say fight for the ideal world, we'll never make, the world better, right? So probably we'll never get the ideal world to the ideal scenario, but at least we can, we can try, do our best, and we'll probably get to a much better place.

So, I hear what you're saying and, um, to summarize, um, We, we need to focus on the innovation. I would actually do it like the take the next step innovation, but the actual value we're bringing in life sciences to patients, to healthcare. So that should be the ultimate focus. Risk is probably some criterion that we need to consider and understand.

Also, the rhetorical investment is important, but probably balancing somewhere in the middle will be key. And, um, hopefully, um, in the next years, we'll see more innovation. Meaning better healthcare. And yeah. Thank you so much Duncan for sharing this with me and sharing your thoughts and, uh, your experience, uh, with me.

Uh, I hope that more people can really contact you and also share their opinion on the same topic. And I'm so happy to see another person open to technology, innovation and just sharing your thoughts and changing your habits.

I really wanna thank you for your graciousness and energy and inspiration. You're doing great work, you and your team, and I wanna end on this note. We talk about a lot of hard skills and things needed in the world today,

but we need more empathy and soft skills diary. And so I wanna end on this note.

If, if I might, uh, I read a profile on, uh, LinkedIn Social Profile and I'm gonna let your listeners think about who this might be, but it speaks volumes to me and I think this is what we need more of. I get inspired by stories, not just facts. And I believe the clinical research industry has many stories every day that are calling for a change in how we think and operate.

My strongest skill is empathy. My principles in life are to be trustworthy, care for other people and to give first. I also cherish my never-ending curiosity about life and how the universe works, how to improve ourselves in our environment. And I just wanna end on that note and thank you very much, Maya.