It is no secret that clinical trials play a crucial role in determining the safety and effectiveness of new medical treatments, Tenaerts tells Outsourcing-Pharma.
However, she says they have long been plagued by inefficiency, high costs, poor patient retention and lack of diversity, among other issues. In fact, the National Institute of Health estimates that 85% of all clinical trials experience significant operational delays, with 94% being delayed by over a month.
Medable is aiming to make the process less cumbersome, using its decentralized clinical trial (DCT) technology to reshape the way trials are conducted.
“My job at Medable is to provide the evidence that decentralized clinical trials work in the way we hope they do. We have seen that technology has the potential to make clinical trials much better and more productive,” Tenaerts says.
A member of the Junior National Volleyball team in her native Belgium, despite pressure from her coaches to pursue an athletic career, Tenaerts knew that she wanted to be a doctor from an early age.
After medical school, she became a general practitioner in Belgium before seeing an ad from The Catholic University Leuven in collaboration with Duke University for a doctor who could speak multiple languages and wanted to travel.
At age 27, Tenaerts accepted the job, where she “fell in love” with clinical research, explaining “I love that you can set up an experiment and establish a methodology to determine if a new treatment works or not. Working in clinical trials is like being an explorer of medicines.”
After a stint as executive director of CTTI (Clinical Trials Transformation Initiative), a partnership between Duke University and the FDA, Tenaerts joined Medable in 2021.
What does Medable do?
Medable’s software-as-a-service (SaaS) platform has been used in more than 300 decentralized and hybrid clinical trials, serving over one million patients and research participants in 60 countries.
“Essentially, we are aiming to bring all the different components of clinical trials under one roof,” Tenaerts says.
The company’s technology enables remote participation, so patients can take part in trials without needing to travel to a clinic every time they need to be tested.
“When you do clinical trials, a lot of people use a lot of vendors. There will be one person that does consenting, another than does clinical outcome assessments and all the information is separate. However, when you use a technology like Medable, all the data is streamlined through one system and it's only one vendor you're dealing with,” Tenaerts says.
The technology can collect a diverse range of study data – including patient reported outcomes, smartphone sensor data, contextual data sets (UV index, urban air pollution, location), and medical and wearable device data.
Medable has partnered with several pharma industry giants, with GlaxoSmithKline (GSK) recently selecting its DCT platform to use across its portfolio, indicating a wider industry shift towards hybrid and decentralized trial models.
In addition, this month the US Food and Drug Administration (FDA) released new guidance in favour of DCT’s to “provide clarity” on the agency’s support for these “innovative trial measures”.
“The new guidance has taken DCT’s to another level of validation, by having the backing of such an important body in the US and around the world saying that we support DCT’s as an effective mechanism to conduct trials,” Tenaerts says.
How is it improving the clinical trial landscape?
According to Tenaerts, Medable’s DCT technology can not only collect more accurate and nuanced medical information, but also improve diversity and inclusivity among participants.
In a traditional clinical trial, patients would come into a centre every month to do a standard assessment, such as the 6-min walk test (6MWT) to determine if their condition is improving or declining.
The 6MWT is a commonly used metric of walking capacity in people with Parkinson’s disease.
“However, Parkinson’s is typified by having good days and bad days. So if one month you come into the clinic on a good day and the next month on a bad day, it doesn’t give us a comprehensive overview of how that patient is doing,” Tenaerts says.
“Whereas if you were to use a Fitbit, or something that you measured every day, you have more continuous data which may be better and give you more information about how that patient is doing.”
Technology can also enable companies to collect patient data faster, which can be crucial when large amounts of money are on the line.
“For sponsors of clinical trials, if they have a product which they think will help a lot of people, it’s vital to get that product on the market as soon as possible,” Tenaerts adds.
“To be able to do that, you have to have a clinical trial that ends and you need to have positive data to show that your product works.
“If you have a blockbuster drug on your hand, its millions of dollars a day. It’s important to get the treatment out there, for customers and also for sponsors – so they can get return on investment.”
While Tenaerts acknowledges that investing in technology can make your trial more expensive, she cites research from Medable and Tufts University showing that, on average, companies who make the investment can end their trial 3 months earlier – which can save significant amounts of money.
Tackling the diversity issue
The expectation that patients must travel to a centralized site to take part in clinical trials has resulted in a severe lack of diversity.
However, Tenaerts argues that decentralization mitigates geographical and socio-economic barriers, to reach a larger and more diverse pool of patients.
“DTC’s can remove geography as a barrier. But while geography as a barrier is distance, sometimes it can be modes of transportation,” Tenaerts says.
“If you are in a lower economic group, you may not have extra money to take a bus to the site, let alone the time to participate and maybe you don’t have anyone to watch your kids. So the convenience factor for patients is extremely important.”
Tenaerts explains that she ran a trial site in Florida for 12 years, but most of the people able to participate were older, white males who were retired and therefore had ample time and resources to visit.
“Historically, the industry has not been good at enrolling the people in the trial that look like the people who have the condition you're studying. If a disease is particularly prevalent among minorities, its important that we provide a mechanism for everyone participate and that we make that possible,” she says.
“If you only study something in Caucasian people or people from a higher socio-economic background, the medication may work in different ways. This doesn’t always have to do with how the medication itself works, but how these patients live and the social determinants of health.
“For instance, if people live in food deserts, if they can’t make healthy choices, whether that’s exercising or food of if they can’t see their doctors regularly – that changes how well or badly a drug can work.”
What still needs to be done?
Despite hailing the benefits of Medable’s DTC technology, Tenaerts admits that there are still wider societal barriers to overcome.
“It’s about being thoughtful and honest. There are still many areas in the US that don’t have access to Wi-Fi in the way that they should,” she says.
In fact, the Federal Communications Commission found that approximately 19 million Americans, 6% of the population, still lack access to fixed broadband service at threshold speeds. In rural areas, nearly one-fourth of the population, 14.5 million people, lack access to this service, rising to one-third of the population in tribal areas.
One institution attempting to tackle this issue is the US Veterans Health Administration. When the organisation started conducting televisits, it found many veterans could not participate due to a lack of internet connection, Tenaerts explains.
In response, they set up a contract with Walmart, enabling veterans to use the retail giant’s Wi-Fi and computers so they could participate in trials and input their health data.
“Therefore, we need to think about different models and facilitating services where patients are excluded due to circumstance,” Tenaerts says.
As clinical trials are a central part of discovering and developing new medicines, the landscape will continue to evolve, with individuals like Tenaerts championing technological and structural innovations.
“In the end, if applied thoughtfully – all these technologies have the ability to make clinical trials much better,” she says.
“For this technology to be widespread, a lot of things need to happen but its good we’re at the forefront. We will keep pushing and adapting to the ever-changing requirements of patients and industry.”
