Less Waste More Haste: Safer Clinical Trials and a Cleaner Planet - Jeanne Hecht, Malia Lewin

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HANNAH LIPPITT: Hello

and welcome to the Totally Clinical podcast brought to you by Teckro. Totally Clinical is a deep dive into the freshest trends, big-time challenges and most excellent triumphs of clinical trials. I'm Hannah, your host. Join me as I chat with industry experts, trailblazers, thought leaders and, most importantly, the people benefiting from clinical research. So, tune in, settle back and don't touch that dial. It's time to get Totally Clinical.

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HANNAH LIPPITT: This week, I am joined by two guests to discuss the subject of clinical trials and sustainability – a word we've been hearing a lot about over the last few years. First, Jeanne Hecht, founder and CEO of JTH consulting and associates, who put together a value model on the impact of the Teckro platform on sponsors, and second, our global head of strategy, Malia Lewin, who worked closely with Jeanne on the value model and who is very optimistic we will see paperless trials in the next five years.

Welcome to the podcast both.

Malia, as I said in the introduction, the word sustainability is talked about a lot, especially in the corporate world where not everyone automatically thinks about clinical trials in the context of sustainability. Could you explain a bit more about the link between the two?

MALIA LEWIN: Sustainability is a very buzzy word, I think, not just in our industry, but in all industries. And I think, you know, most people, the universal assumption is that sustainability is environmental consciousness, and it might be difficult for some folks to see the link between clinical research and, you know, the environmental potential environmental impact of research, especially in the digital world that we live in. But clinical trials are still driven mainly by manual and paper-based processes that impact sustainability when it comes to printing and shipping paper documents in support of multi-year global clinical trials. And although, you know, for many industries, digital has, you know, shifted the, you know, carbon footprint considerably, it's, you know... our industry is lagging behind a little bit. And so what with Teckro, you can really help replace, you know, some of that, not just the cost, but also the larger environmental

impact with this digital alternative.

HANNAH LIPPITT: Jeanne, one cost saving that came up was around the digitization of the clinical protocol and other documentation. Now, this isn't only helpful for sponsors, but also great for the environment. Could you give an overview of the value model as well as this particular finding?

JEANNE HECHT: Last year, in 2021, I was commissioned by Teckro and had the pleasure to work with Malia and the team to quantify the impact of Teckro and its platform on sponsors compared to standard operations. And you rightfully said that the digitization of protocols – as well as many other study documents, be it an investigator's brochure, a pharmacy manual and other supportive documents that clinical research sites need in a clinical trial – is a key component of their overall platform and offering. So I looked at the impact of those specifically across a study involving 250 patients at 40 sites over 60 months. And during the evaluation, I had a number of different calls with both sites, CROs, and pharmaceutical and biotech sponsors, and obtained information from all of those different parties on the positive impact of the platform as it relates to sustainability efforts.

I also received information on, kind of, the average study costs associated with some of the activities and the average resourcing model algorithms for some of the activities that would be positively impacted by the Teckro platform, because we all know that the cost to develop the drug is about a billion to $2 billion, and there's many companies working to solve the efficiency problem, and Teckro’s platform definitely does. So when we looked at the model, I looked specifically at those areas and

the positive impact that they had.

HANNAH LIPPITT: Were there any other findings, Jeanne, you discovered that could help to increase trial sustainability while also being of value for sponsors?

JEANNE HECHT: Most definitely. So, when I think about trial sustainability, I'm thinking about the ability for a sponsor to reduce the number of resources that are engaged in a particular trial. You know, many of these resources travel to research sites, and our ability to actually reduce the need for travel is a positive impact that Teckro has on a clinical research study and its ability to actually reduce the waste that often comes from inefficient communication – so via emails and unnecessary in-person meeting – as well as then the need to print and file some of those or print and review some of those communications is reduced by using the Teckro platform that allows you to digitally search for information on the clinical research documents that are contained within its site.

So, a typical lead CRA or CRA or CTA and the model we uncovered the ability for us to reduce the amount of time that those individuals are engaging with their research site in certain components of their work effort by about 30%. And then the medical monitor that also spends a considerable amount of time engaging with the site answering questions for the research site – we also uncovered that they would be able to reduce about 10% of the time using typical CRO crowdsourcing algorithms that were provided by two different

interviewees from two different CROs.

HANNAH LIPPITT: Malia, the results of the value model tie-in with Teckro’s commitment to sustainability, as well as being extremely cost-effective for sponsors. Was there anything that surprised you about the report?

MALIA LEWIN: No, I mean, I think, you know, Jeanne has done such a nice job, you know, framing the issues around sustainability with clinical trials, and, you know, this is something that was really important to our founders when they created Teckro – it was to really create an opportunity for sponsors, not just to move to more sustainable methods, but to really get the speed that comes with digital and can help trials move quickly without any compromise to patient safety or to data integrity. And so when the results came out, you know, I was really happy to see some of our hypotheses validated. And what's really been interesting is just to see how many sponsors are now actively using Teckro and what we're able to do to change their SOPs and really fulfill their own promises to move the needle on sustainability.

So, you know, when it comes to change management in our industry, many think that our processes are driven by regulatory requirements. But when sponsors are looking at these results and trying to move forward with Teckro, it's interesting just to see that it's really the SOPs that are codifying, you know, a business process and that those business processes can be changed and they can be updated and they're not regulatory requirements. There are just

a codification of an old way of doing things.

HANNAH LIPPITT: And Jeanne, was there anything that particularly surprised you?

JEANNE HECHT: Yes, there was a couple of things that I was pleasantly surprised about. So first, as Malia mentioned, change isn't easy, and a lot of companies' operational procedures dictate their overall processes, and they come from a legacy of operations not necessarily always rooted in regulatory requirements. And one of the things that I found interesting outside of the positive environmental impact that the Teckro product can have – and platform can have – on a clinical trial and a research or a pharma company sustainability effort, but also on the area of patient access. And clinical research, historically, has been held at academic and large medical centers. What that means for an individual is an individual patient or participant, as they often have to drive long distances to be able to participate in a clinical research trial. And that has a negative impact not only on our environment, but also on the participation rates due to social and economic pressures impacting a participant. Can they take the time off of work, the cost of gas, child care, et cetera?

So when we looked at the Teckro platform and compared it with some really good industry research out there, we believe that there is a very positive impact around using the Teckro platform on research-naive sites to help bring clinical research as a care option to community-based care centers, which allows the clinical trial participant or the patient to actually receive care closer to home, which would have a very positive impact on the environment as well as participation rates.

So in some of these new approaches, also ensuring pharma companies are often concerned as well or CROs on ensuring that the high quality of clinical trial execution continues on at a research-naive site. Well, the Teckro platform provides a level of comfort in the ability to do so because it allows the clinical research staff at this community-based health care center to be able to search clinical trial documents to find answers and therefore to reduce errors. It also has a really powerful engagement tool similar to like an instant messenger or a text that allows you to get really quick access to study teams or sponsor staff without having to play the telephone game, without having to send emails and await answers and provide high quality patient care at the time in which that patient needs that care. All of that leads to a reduction in errors, which allows us to reduce the amount of paper that we have to produce to document those errors.

And so when I started to really think about it – the positive impact and hearing from individuals about the positive impact of Teckro’s products and platforms and the ability to bring clinical research as a care option to the community-based care center and the research-naive sites – I thought, “Wow, this isn't just great for the

environment. This is also amazing for the patient.”

HANNAH LIPPITT: Malia, if we think about the fact that the future is sustainable, as well as how slow some industries are to adapt, what kind of time frame do you believe is realistic for trials to become fully paperless?

MALIA LEWIN: You know, I think the demand has changed considerably as a result of COVID-19 forcing, you know, the acceleration of technology and, you know, a real... not just interest, but a demand for the adoption of new technologies to support both sponsors and sites to move forward with more efficient systems. So, we all know that paper in addition to being costly to the environment and, you know, it's very, very inefficient, and I think that we've learned just how valuable technology can be to us when we need to move quickly in clinical research. And as we think about the broader implications of speed when it comes to, you know, these life-changing and life-saving discoveries, getting them to market is really important and being able to leverage some of our learnings from the past couple of years, I think that where we're close. And I could see paperless trials

becoming a reality within the next five years.

HANNAH LIPPITT: That's great to hear. Jeanne is there anything else you'd like to add here?

JEANNE HECHT: Yes, I think clinical trials are challenging and they're exciting. And what we've seen over the last two years with the evolution of how clinical trials are conducted – where patient care can be delivered in a home, at a satellite center, at a community-based care center – is quite amazing. I'm pleased that the industry is also open to looking at the technologies of the future and those that are required to be able to deliver on these trials successfully. And I think that's where there's a nice intersection between Teckro and decentralized trials, Teckro and engaging patients at community-based care centers. There is a wonderful offering here, which will help us to deliver

on the trials of the future and get out of the past.

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HANNAH LIPPITT: And that's your dose of Totally Clinical. You can download our podcast on Apple, Spotify and Google. Please subscribe and leave a rating and review so more people can find the show. See you on your next visit and remember to bring your friends. Thanks for listening! Goodbye!

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