Clinical Trial Innovation: The Good, the Bad, and the Ugly - Malia Lewin and Tom Julian

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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: Does the word “innovation” fill you with optimism or dread? Innovation means

change and change means disruption; a leaving behind of the old ways and embrace of the new and unknown. On the other hand, change can be exciting and opens a world of possibilities, certainly in clinical research, which conservative by nature, has been somewhat impervious to innovation over the years. But the reality is that clinical trials must adapt to the ever-changing technological landscape or be left behind. And while great progress has been made during COVID-19, the risk remains that the necessary industry adaption under pressure during the pandemic will be short lived.

Here to discuss what drives, scares and inspires us along the innovation road in clinical trials are Teckro’s, Global Head of Strategy Malia Lewin and clinical trial innovation consultant Tom Julian. Welcome, Tom and Malia. Now, let's start with a simple question: what is innovation and why does it matter in clinical trials? Malia, let's begin with you.

MALIA LEWIN: In clinical research, we all know it's essential the patient safety and scientific rigor are prioritized. For many in the industry this has equated with a slow and deliberate pace. The role of innovation in clinical research is really to find better ways of working that increase speed and agility without compromising the safety and quality of the research. In fact, effective experts like Tom have managed to find innovations that can improve speed, safety, quality and the satisfaction of all stakeholders in the process.

HANNAH LIPPITT: So

over to you, Tom. What are your thoughts?

TOM JULIAN: So our industry is under incredible pressure and fierce competition, and I think what we learned from COVID is that we have to be flexible and open to trying new things. That was thrust upon us and we didn't have a choice to try decentralized trials or revisits and things like that. We were lucky that consumer access to phones, cameras, broadband, et cetera was as mature as it was for us to take advantage of that situation – as bad as it was in a way. Health care was able to adapt the pandemic and ride it out a bit, and hopefully that's something that we can retain going forward to keep progress going.

But could you imagine what would have

happened if the pandemic hit 20 years ago? Like when we didn't have the capacity or even the inkling to perform work from home or medicine remotely? Not that everything in our industry should be an emergency, but we need to constantly be looking for those opportunities to do things better, faster, and without so much burden. I encounter study teams that are experiencing challenges each and every day. How do we find new patients? How do we do some visits remotely? How do we monitor patients in real time? I'd really like to be able to open up my innovation box of innovation toys and put them together in new ways to solve problems. We always need to be in a progress and problem-solving mindset, my opinion.

HANNAH LIPPITT: Could you talk us through how you build support for your innovation programs and how you know if you're successful Tom?

TOM JULIAN: Yeah, of course. So that's a great question and sometimes you don't have to look very far when the program has clear and evident value. The best programs I've worked on, the study teams have actually come to me and said, “Hey, we really want to do this. And we need your expertise to see it through.” On the other hand, when you've got a hammer looking for a nail, that's not such a great place

to be. You end up looking for the study and there is a temptation to shoehorn an innovation into a program that really doesn't need it. Time constraints might be pressing you to select the study that might not be the best fit. It's also always great to bring money if there is usually much less resistance to try new things when you fund it. And don't forget to tell your success stories. Even if they are modest, it's important and the innovation group can show real activity and impact and show that you're not just a debate club.

HANNAH LIPPITT: And Malia, what are your thoughts?

MALIA LEWIN: You know, across customers, at Teckro, we've seen successful innovation teams really drive change by listening to the unmet needs of their business stakeholders and really using those pain points to drive KPIs for new solutions. At Teckro, for example, we hear a lot about site burden from study teams,

so we make it a point to assess site satisfaction for each customer and provide site engagement data to innovation teams so that they can use that in their overall assessment of Teckro.

HANNAH LIPPITT: Now, we've seen rapid success in adopting innovative approaches to clinical trials during the pandemic. But despite the progress, stakeholders are still overly burdened – I've spoken to a lot of them on this podcast. Could you talk us through how innovation programs are falling short, starting with the problems affecting investigators and

sites? Malia.

MALIA LEWIN: COVID-19 created a need for the immediate deployment and adoption of new technologies to support a different way of working. In addition to enabling shifts to decentralize trials and hyper trials, protecting the safety of all research stakeholders meant going digital to replace manual processes and in-person interactions. So, we now have a situation where the number of solutions is creating a burden of its own on sites and CRAs, with numerous passwords required to access each study and the exponential building of this burden on sites running multiple studies. It's causing people to question the value of the original innovations now that there are so many of them, and at Teckro, we're actively working to solve this problem by allowing the effective flow of information through the platform, so that there isn't as much logging in and logging out of different solutions.

HANNAH LIPPITT: What about the sponsor perspective, Tom?

TOM JULIAN: I call this phenomena "NAP” – not another portal –

and I usually get nodding heads when I make that joke but sponsors have to keep in mind that we are one of several that sites they are working with. If you have all your sponsors asking you to use different tech and remember different passwords, sites could get confused, flustered, frustrated, even non-adherent. Some of them, rightly so, have asked to be paid to use a tech portal unless it's specifically spelled out in their contract ahead of time. One thing that I recommend is adding use of a digital innovation to the protocol, if at all possible. That way, it's part of the operation of the trial and not some additional thing sponsors come along later and ask sites to do.

HANNAH LIPPITT: Yeah, that's a really interesting idea. I'm not sure how easy it would be to implement that?

TOM JULIAN: Sometimes the endpoints require

the collection of some kind of data point, whether that's going to be patient experience or a side effect or something of that nature. So, you can write it in there that “x” data point must be collected in some manner and then essentially provide the innovation to write along with that. So, in essence, you can ask for “x” thing to be collected and then provide the means of collecting it if you don't exactly know what technology you're going to use or if you're expecting there to be changes in the way that you collect.

HANNAH LIPPITT: And moving on to CROs:

where do they fit in this discussion? Do you believe that resistance to change plays a big role in terms of challenges when it comes to innovation? And if so, Tom, how can we combat this?

TOM JULIAN: I was just talking to one of my CRO friends about this. CROs have a ton of experience that sometimes sponsors don't tap into. They see dozens of protocols in our therapeutic areas from other sponsors, and usually they would be happy to tell us of their lessons learned as it makes them much more successful as they try to run our trials. But often when it's time to hand over a protocol to a CRO, it's done and dusted. The timelines are tight and the teams have a million things to do. So even if a CRO might have plenty of useful intelligence, we're like, “Thanks, but please just run the protocol. There's no time to fine tune it.”

HANNAH LIPPITT: And Malia, what are your thoughts on CROs?

MALIA LEWIN: Well, although many technology companies see CROs as a frenemy of sorts, at Teckro, we work very closely with CRO partners, and what we're seeing is a lot of CRA burnout. You know, we're used to seeing a certain amount of turnover with CRAs, but what we're seeing is CRAs actually leaving the profession entirely. And this is a problem for all of us to solve. We're partnering really closely with CROs so that our technology lifts the administrative and manual burden that's currently on CRAs, and that's really allowing them to spend more time on the valuable service they provide to

protect patient safety and data integrity.

HANNAH LIPPITT: So what does the future hold? How can innovation inspire us? And Malia, what lies ahead, in your opinion?

MALIA LEWIN: I think innovation is required to smooth a safe and efficient path for life-saving and life-changing scientific discoveries to reach the market. We just need to make sure that we keep the end users in mind and learn and share best practices from experienced professionals, as we've done today with Tom.

TOM JULIAN: I think we need to focus on both the really simple things as well as the complicated things, and always keep the patient in mind. And what do I mean by simple things? Can a visit be virtual? If so, make it a virtual visit. Why make someone drive or take off work when it's not needed? Can a protocol title be written in plain English show a patient might be better able to understand if they qualify? Can a few simple yes or no questions help them in that regard? Things like that are not hard, but we unintentionally gatekeep access to clinical trials because we don't think about the patient all the time.

And so what's the hard stuff? Well, a patient should be able to control their health record in real time. We can't find patients for trials because we have to figure out how to market studies to patients or scan far flung EMRs. What if you own all your health info in a digital vault? All your providers write to and read to your records with your permission. That's all your information and you control it. From there,

you can opt into taking part in trials and other medical activities. That's the future. And it was done in finance 20 years ago and I think health care needs the same kind of revolution.

HANNAH LIPPITT: Yeah, I suppose there are all sorts of issues that can arise around people concerned about privacy, gatekeepers, et cetera.

TOM JULIAN: Yeah, absolutely. I think that our industry is an incredibly well-meaning industry and filled with people that really want to do the right thing for patients, for science, for progress, for the companies they work for. And oftentimes we're focused on specifically our endpoints and the way our protocols are written and running them efficiently. And it can be hard to keep the patient always at the forefront when you're trying to accomplish all that stuff. But the patient is really where it all begins. So if you think about it, saying “yes” to taking part in a clinical trial

is really where the heroic start of a clinical trial is. That patient that's become a hand raiser and said, “Yes, I want to take part. I want to be part of science. I want to be part of helping people.” That's where our focus needs to be.

HANNAH LIPPITT: That's really interesting what you said there, Tom, actually, because we have a podcast by somebody from Greater Gift – they reward patients for taking part in clinical trials, which is interesting, tying into your last point. And Malia, do you have anything to add to Tom’s point about the heroes of trials?

MALIA LEWIN: I think that last point was really important about patient engagement and really celebrating the heroism of patients who decide to participate. You know, I think that also brings up another point around, you know, one of the core aspects of Teckro’s mission is to get every physician

engaged in clinical trials. And I think having more and more community-based physicians, more general practitioners, more physicians generally aware of and engaged in the clinical trials process, will allow those patients to really be referred to clinical trials as a care option. And that's going to be better for research. It's going to offer patients additional options for care. And so I think that last point was really important, that it really is going to take all stakeholders engaged in clinical research to drive some of these innovative approaches.

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!