Challenges and Opportunities for Clinical Trials in Developing Nations - Robbyn Mattei

This week, Robin matei, co-founder and director of alpha trials, joins

me on the podcast. Robin, could you start by explaining more about what inspired you to get involved in the industry? I started off with a BS in biotechnology, and I was quite interested in advancing human technology and more specifically in how we can use genetic engineering to eliminate genetic diseases. So after working in a pharmaceutical manufacturing facility, I diverted my attention toward computational biology, and it was a big change in direction

for me as I've never actually been involved in the computational science before, and I wanted to understand the demands and the requirements that bioinformatics had in breaching the gaps between biological research and computer programming.

And after graduating with honors in bioinformatics, I dove headfirst into clinical trials. And I assisted a major lab in specimen management, staff and site management and assessing the quality of laboratory protocols. And this is really where I got to see some real gaps in the industry. And when I realized that there's a lot of changes that need to happen if we wanted South Africa to become a focal point for global trial sponsors.

So my partner and I, we started, we got together and we started to brainstorm what these challenges were and finding ways that we could overcome them and build a new mentality toward clinical trials across the country. Great could you explain a bit more about the specific problems facing flint, so I know that. So I know that there are specific problems facing clinical research sites and laboratory staff in South africa? Oh, by the way, robyn?

Yes could you mute when I'm talking because there's quite a lot of noise in the background? And also, I don't know if you can. If there's a way you can ensure that noise doesn't get through or if you've got headphones use. I don't have headphones at the moment.

That's OK. I have to fight with

what we've got. If you just mute when I'm talking because I can hear noise, I mean, I can always redo the questions I will anyway. But the intro, for example.

But if you could, just that would be easier. OK so I know that there are specific problems facing clinical research sites and laboratory staff in South Africa. Could you explain more about these? Um, so before I answer that question, I wanted to add a little bit of background context here, and to put into perspective, we have nearly 420,000 registered trials across the globe, and South Africa is only carrying about three 3,000 lives and 3,200 registered trials as of today.

So that's less than 1% of the global trial industry, and it really puts the degree of difficulty in

running trials here into perspective. For me, at least, this is what got me thinking about why South Africa had such a low trial participation despite having organizations active here for over 40 years. And it is worth noting that regulations only became mandatory for registered trials in the late 90s in the US and in South Africa only at the end of 2005. So there are several persisting issues that we're facing across South Africa at the moment.

And when I say persisting, I really mean that these issues have been around. For a while, and they're not new issues, it's actually become a focal point for many thesis work, so there are published articles highlighting the same problems each year. I think one of the biggest challenges contributing to towards trials and conducting trials here has always been costs, and it ties in closely with regulatory control. But the addition of the South African health products regulation.

True agency has dedicated clinical trials division to improving on regulatory and approval processes. Many sponsors are still finding South Africa to be a high cost environment, and that often deters them from funding trials in the region. I think shipping has always been a driving factor for these costs and has become more problematic given the effects of the pandemic along with the russia-ukraine invasion. There are also cultural challenges that we're facing across the board here.

We have 11 official languages, and English is only the fourth most spoken language in the country.

So it's really difficult to develop effective communication protocols that aim to bring adherence to study visits and to keep participants coming back. Often we're finding that difficult cultures view or sorry, can I start that last paragraph over? Of course, I also think I'm probably going to add in a question around.

Um, cultural changes, so maybe. You mean that paragraph, don't you? Yes Yeah. So found in a question that because I just wanted to break up the text or something like it's not only it's also a question of culture or maybe how does the culture in South Africa affect the industry?

Yeah, Yeah. OK so how does the culture in South Africa affect the industry? There are a number of cultural challenges that we are facing across the board here, with

11 official languages and English being the fourth most spoken. It's really difficult to develop effective communication protocols that aim to bring adherence to study visits and to keep participants coming back.

Often we're finding that different cultures view the importance of medical research quite differently from those conducting the trials. And COVID 19 really showed us that a large portion of the population in South Africa is quite skeptical about trials and about medical research. So recruitment and retention can be very difficult if we don't focus on developing effective communication with participants. Communication barriers aren't only limited to culture, but also include technical challenges like network signals and access to New technologies.

The world is moving towards decentralized trials, but in developing nations we're still trying to catch up with current technology and the necessary infrastructure for that. So beyond participants, that's great,

that's great. I had I may add in a question here. Sorry, you've offered so much information, which is amazing.

Sorry no, no. It's good. I'm going to talk about skepticism and ask what the reasons you think for skepticism are. And then moving into the lab, I would like to add another question to break up.

Maybe there or maybe you could add it on the back of the skepticism answer. Let's let's do it separately, because then I can do. We're now going to the lab and look at employees. I can refer to Nikki's podcast as well.

OK, so new question, you mentioned skepticism. What do you believe? The reasons for skepticism is maybe you can talk about specific cultural reasons there. I think that's very interesting.

And then beyond trial participants and trial costs, there are real challenges in the lab and. The companies doing probably OK, and I know I can then say, and I know that you were inspired by a recent podcast with Nikki Osborne. Yeah, sounds good. This might be better because when I look to your initial answers, they didn't look so long, but I'm thinking when I'm hearing them, it's going to be quite long, which is good, by the way.

Not bad, but I'm thinking to break it up a bit because yes, I think you have they're all such good answers. There's no waffling, but if we can just kind of break them up, I think it would just have more impact. So if I say you mentioned skepticism, what do you think the reasons are for this? You mentioned people are going to be skeptical about trials.

What do you think the reasons are? I'm sure you have an answer to that. And then maybe I can say

I know you were inspired by a recent podcast, Nikki Osborne from Meridian clinical research. Um, we can do it like that.

Yeah does that work for you? Yeah Yeah. Cool I think it will really work well. Then there'll be less editing afterwards because it's in the right order, so.

And that it hit home, it hit home, didn't it? Yeah, OK. Yeah, didn't it? If that's something people understand, I think they do, and it hit it.

I know your reason is 5 recent. Can I hit home a bit? Yeah OK. So you mentioned that people in South Africa can be.

You mentioned that people in South Africa can be skeptical about trials. What do you believe the reasons are for this skepticism? I think a lot of it is a lack in education and understanding what we're trying to achieve. And a lot

of it is also based on what we hear, you know, whilst we are still developing a lot of the infrastructure and access to online materials.

This there is access to a lot of misinformation and a lot of, should I say, conspiracy theories around what we do in the medical industry. So a lot of people attribute, you know, style Star Trek and other types of movies and things like that to the medical industry. And they see it on TV and the movies and reading books, and they think that's really what we do. And so really, I think it's about educating people, getting them to understand what it is that we do in the medical industry as researchers, and that we're not just about science fiction and make believe, but we're trying to bring health and prosperity to people and trying to eliminate disease and and disorders.

Yeah brilliant answer. Great no, really good. Excuse me, sir, I have a little bit of a cold so that my voice is a bit froakie. And I know that you were recently inspired by a recent podcast we did with Nikki Osborne from Meridian clinical research, and that you feel that some of the working culture in South Africa could take on board some of the working practices.

She mentioned. Could you talk a bit more about this? I think going

beyond participants and trial costs, there's some real challenges in the lab and particularly in how companies value their employees. And for me, this is likely the biggest damaging factor in conducting effective trials.

For the most part, many companies on a global level tend to be more shareholder driven. And this means that they value profits over other concerns and being inspired by Nick Osborne's podcast on here. It discussed stakeholders and culture. And we really need to change how we treat and value employees if we want to create an environment of loyalty and prosperity when we change our focus through all stakeholders.

We're creating a loyal and dedicated workforce, loyal clients and enduring relationships that will ultimately please the shareholders. Currently, staff are being overworked and overlooked, so they end up burning out and risking complications for many samples that they're handling. And this actually causes many skilled staff to relocate outside our borders, which means we're losing trained and qualified technicians. So I think that's a good answer there.

It's a very good answer. Did you want to talk about infrastructure? I can mention it, and then we can see if it fits in, maybe just after the cost one. Yes Yeah.

The last thing I'd like to touch on is infrastructure in developed nations, much, much of the US and much of Europe. So let me start that. Talk it over. The one thing that I'd like to touch on is infrastructure in developed nations like much of the US and much of Europe.

There

are significant number of sites and clinical research organizations in developing countries like South Africa. Infrastructure and funding is severely limited, and this means we have fewer facilities that can accommodate clinical trials. So there seemed to be a lot of different factors affecting clinical trials and the industry in South Africa. What are you specifically working on to address these issues at alpha trials?

So also, Charles is working on a few ways in which you can tackle the challenges faced within the South African clinical trials industry. We've been in discussion with a few crows and research institutes and institutions about developing a research hub here in Cape Town. The idea is to develop a collaborative environment between different laboratories, offering a variety of services for clinical and medical research. We're also trying to form the core of clinical trials, processing and management.

Partner labs will conduct routine and specialized testing. We're also negotiating the development of a new BI repository that can tackle shipping and storage demands. We believe that this collaborative effort will reduce trial costs and create a more attractive environment for new trials to be registered in the country without adequate infrastructure. Trials will be severely limited.

The goal here is for all four trials to reset the standards in South Africa and create an environment that improves the integrity for sponsors and cross. Just hold on for me, Anna. Sorry oh, just give me a moment. Sure OK, so I'll continue, so we hope.

OK, so. Yeah, so I think, yeah, if you just. If you just reach the end and then I can maybe add in a questions or break it up a bit afterwards. OK excellent.

This development will also help to integrate people from different backgrounds and companies, creating a collaborative environment that can help bridge cultural barriers. We're hoping that by working with a number of partner laboratories and research organizations that we can help bring new ways to communicate effectively with trial stakeholders and improve participant enrollment and retention. Part of creating a more informed culture is also teaching staff and participants about these trials, not only about what we're going to do, but why and how. I found that many people, including technicians, understand what part of trials, but not always the why behind our processes or the importance of compliance and training, by training, by training and educating staff and by informing participants and the public of the trials hopes to bridge cultural disparities that are leading to low retention and high staff turnover.

Which brings me to my final stance on how we can reshape the trials industry across South Africa stakeholder mentality. And again, this ties in with what Nikki Osborne was talking about of the trial's aims to create an environment that values its employees by listening to staff concerns, taking their ideas seriously and paying attention to them. We hope to show that the industry that loyal staff create a high value professional environment. And as I mentioned, staff turnover is high and many skilled personnel are relocating to other countries.

If we want to develop a world class trials industry, we need to change how we treat staff. Alpha trials will implement policies that enable us to do just that without having to sacrifice integrity, profitability or ethics. Great I think that was good, I think I probably will break that up a little bit. And, you know, maybe shorten it a bit or add in a comment.

That's perfect. Yeah so you're obviously doing a lot of work, you must have faced a lot of challenges. Could you explain more about these and how you think and how you think technology could help address these challenges? I think the takeover would be a great asset.

Into into the lab and into trials, communication issues, as it not only creates a good resource management system for all trial documents, but also makes it really easy to communicate with relevant people involved in the trial. I read the typekit pro edition and I found the app really easy to use for trial documents uploaded with the latest version, so it makes search options really easy to find answers for and specific information without having to leave through a PDF or printout. But what I really liked was how much simpler it wants to communicate with investigators, vendors and other stakeholders.

And before anyone asks about privacy or limitations, staff are only connected to the trials that they were registered on by the employer. And so this means that your trial documents and your communications are kept within the trial itself, so it's very confidential and safe. Beyond that, the biggest challenge that we're facing now is adequate investment. South Africa, along with many developing nations, suffers from a lack of funding towards startups and more specifically when it concerns infrastructure.

So we found that a lot of our agencies and a lot of the funding organizations focus on direct patient care and direct product development, and so they skip over the importance of proper infrastructure and and qualified laboratories. And this often leaves the industry in a predicament of not enough space and not enough infrastructure to conduct trials within. What are you positive about for the future of clinical trials in the region? And why do you think the international clinical trials industry should be paying attention to South africa?

We're positive about the research hub, as the idea has gained a lot of attention and we're discussing the development with different organizations, although we're still looking for adequate funding measures. We're excited that we have interest from cross and networks and sponsors. This shows me that we're headed in the right direction. South Africa is also an incredibly diverse region.

There are people here from part of that form, part of many cultures, religions and backgrounds, so trial participants can be from a wide range of demographics and can cater to many different trials. Saffron is really tackled the bottleneck in for approval and aims to have concluded decisions within 12 to 16 weeks from sorry from a regulatory perspective. We've had some great changes to improving the IP for sponsors and organizations. Despite rising costs, the exchange rate is also making it an attractive location for international sponsors.

I'm hopeful, I'm hopeful about reaching communities and educating the general populations on how and why clinical trials are conducted. There's been a lot of research recently in ways we can tackle cultural barriers in the country, particularly in trial retention. I think that this research will have a positive outcome on see our own science communicate with and handle participants, especially from a rural and informal settlements. South Africa is a developing environment, and there are a number of skilled and dedicated research companies improve upon the industry here.

There's also a demand for collaboration, which makes me really excited. I draw the concept of inspiration because we can't do everything ourselves. There's that old saying it takes a village, and in my experience, successful trials takes a few really good villages.