“When enrollment isn’t met, budgets are broken. Timelines are delayed,” said Matt Teuteberg, president and CEO of patient recruitment technologies firm Splash Clinical.
Teuteberg spoke during a panel at MedCity News’ INVEST Digital Health conference in Dallas. Joining him were Kwame Marfo, head of market strategy and innovation at Komodo Health, and Pamela Tenaerts, chief scientific officer of clinical trials software company Medable. The Thursday panel was moderated by Raj Rajendran, associate partner at McKinsey & Company.
Marfo said he sees greater use of data in the design and execution of clinical trials. Komodo works with de-identified patient data from payers and healthcare providers. Analysis of these data can offer identify trends in the diagnosis and treatment of a disease. The startup’s customers include biopharmaceutical companies. Marfo said that technology in clinical trials is becoming more personalized to account for the development of targeted therapies that address specific patient populations.
It’s hard for people to participate in clinical trials, particularly studies in rare diseases, Tenaerts said. Many people do not live close to a hospital where clinical trials are run. But bringing elements of the trial to patients can make it easier for them to participate. Patients can answer questions about how they are feeling via an app on their phones. Sensors can collect data without the need for a patient to make a site visit.
Tenaerts recalled working at a clinical trial site earlier in her career. At that time, study participants answered questions on paper questionnaires. She could tell that responses that were supposed to made over the course of four weeks were all done at the same time. Now, with responses submitted electronically by phone, it’s clear when a patient submitted a response and whether they stuck to a treatment regimen. Better adherence could lead to better clinical trial outcomes, Tenaerts said.
Medable’s software is used in decentralized clinical trials. But Tenaerts said people are moving away from the term “decentralized clinical trial,” which makes a trial sound special or in need of different regulations, Tenaerts said. Instead, the industry is moving toward the European Medicines Agency approach of talking about clinical trials that have decentralized elements, such as an electronic recruitment system. Teuteberg said one trend for clinical trials is for these studies be hybrid, blending elements of traditional clinical studies with newer components, such as telemedicine. These components can make participation easier for patients and also improve diversity of the trial participants.
“It’s so important, because ultimately, the drugs will be prescribed for everyone and you have to make sure you have a representative population,” Teuteberg said.
Clinical trials tend to collect more data than a pharmaceutical company needs, Tenaerts said. The data collection capabilities of newer technologies mean studies can collect even more data. But the point of using digital technologies to collect better, more precise data. Doing so can reduce the size of the trial. For example, Tenaerts pointed clinical trials testing therapies for the rare muscle disorder Duchenne muscular dystrophy. The six-minute walk test used to be the standard measure of such drugs. Now, clinical trials in this indication use other measures, which in turn allows for trials to be smaller. But Tenaerts added that one limitation is we don’t have such new measures for all diseases.
One remaining challenge limiting the adoption of digital technologies in clinical trials isn’t a technology problem at all. Inertia is a constant barrier to change, Marfo said. But he added that the key to overcoming inertia is generate data that support the use of technology. Tenaerts said Covid-19 provided ample evidence supporting the use of new technologies in clinical trials. There are trends indicating that continued use of these technologies help to enroll patients faster. But more research is needed to answer outstanding questions about these digital offerings.
“If they don’t do what we think they do, we shouldn’t use them,” Tenaerts said. “Or we should tweak them.”