UCB Uses Decentralized Trials To Manage Studies
By Ed Miseta, Chief Editor, Clinical Leader
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UCB has a long history of conducting trials in immunology and neurology, with an emphasis in epilepsy. According to Tero Laulajainen, VP and head of global clinical science and operations for UCB, the company has a broad range of therapeutic expertise and numerous global trials, including studies in China. Therefore, the company expected to be impacted when news of the COVID-19 virus first began to make headlines.
“In November 2019 we began to get word of the virus and the effect it was having on our China operations,” says Laulajainen. “We knew almost immediately that the virus would have an impact on patient recruitment. By the end of December, our trials in China, Japan, Taiwan, and Korea were already being impacted.”
Tech Adoption Helped
UCB was ahead of the curve when it came to implementing digital technologies. Laulajainen notes that foresight helped the company mitigate the impact of the pandemic.
“We were very familiar with decentralized trials,” he says. “Televisits and home nursing were pretty common for many of our patients. We had experience with remote assessments and electronic informed consent. In principle, we were well equipped to address our trial requirements when patients were denied access to investigator sites.”
That doesn’t mean the company did not face difficulties as a result of the pandemic. There was certainly a lot of scaling up that had to be performed. The company acted quickly to put remote monitoring technologies in place for those trials where it was not already in use. In late March 2020, the company had to put new patient recruitment on hold, which did not resume until June 2020. Some studies still in the planning stages were also postponed.
“We have now had a chance to evaluate the impact of what we did in 2020,” says Laulajainen. “We are very happy with the results. We were able to continue to collect data during the pandemic. We were even able to successfully close some key registration studies in the mist midst of the pandemic. It was a tough year but looking back I think we are happy with the way things turned out.”
A Focus On Patient Centricity
Not every sponsor company rushed to get into decentralized trials when the technology became available to do them. In that sense, UCB was definitely an early adopter. Laulajainen notes the primary reason for investing in the technology was the desire to produce more patient-centric trials.
Tero Laulajainen, VP and head of global clinical science and operations, UCB
“We asked ourselves how we could make our trial participation easier for patients,” he says. “In 2017 we began having discussions with the technology providers in that area. We opted to start a collaboration with Science 37 and were one of their five early partners. Patient recruitment is an area where all companies struggle, and we knew we had to reduce the burden of study participation on patients.”
Laulajainen believes travel to and from sites is one of the major burdens faced by trial participants. For patients, living two hours from a site and being asked to travel to it once a week is a challenge. Remote monitoring can help those patients. However, UCB knew other patients liked the close relationship they have with investigator sites. With televisits, patients can interact with the same personnel at the clinic but do so from their homes.
“We realize some patients do not want to give up the face-to-face contact with their physicians,” adds Laulajainen. “But we have to recognize there is a large patient population that has a different viewpoint. They would not be able to participate in trials were it not for a decentralized approach.”
UCB currently has a U.S. study underway where one metro site has a license to operate and administer to patients in 37 states and has the support of regulators.
Work With Regulators
When looking back at the challenges UCB faced in 2020, Laulajainen notes they weren’t related to the technology behind decentralized trials. He notes the technology is well-established and pretty simple to use and understand. The biggest challenge in scaling up was connecting with technology companies at a time when they were being swamped with calls. Even then, UCB had the advantage of having already worked with Science 37 and other providers.
“We knew them, they knew us, and we had done business together,” says Laulajainen. “We were like old customers, and I think that made it easier for us to get other studies up and running. Our main concern throughout 2020 was validation of the assessments. We knew remote assessments would not be equal to assessments that are performed face-to-face. There is an element of validation that needs to happen, or they need to be pre-validated, and then accepted by regulators. That was the biggest hurdle. It’s all about risk, the mitigation of risk, and what you can change before you need to engage in discussions with regulators.”
When going from face-to-face interactions to remote visits, much can change. Laulajainen notes even when the same questions are asked, researchers need to understand differences that can occur due to the change in interface. The main question that must be answered is whether the assessment is the same (or not substantially different) than it would be if it were conducted in person. If the answer is yes, you also need to be able to prove that it is. Statistically, that can be a challenge.
“From a data collection perspective, we need to know the means by which that particular assessment for that particular patient for that particular visit was performed,” states Laulajainen. “There are a number of complications that can arise when doing this in an unplanned, mitigative manner.”
A Different Perspective On Risk
Last year someone told me pharma resisted implementing new technologies because of perceived risks. They also noted that in the future the real risk will come from not adopting patient-facing technologies. Laulajainen notes he is a firm believer in that sentiment.
“In 2020 we saw technology adoption as a contingency measure due to the pandemic,” he says. “Looking forward, I think those changes are here to stay. If I look at what is happening across UCB, we are undergoing a digital business transformation. We used to have a handful of decentralized trials. Going into 2021 we had around 20 trials that are or will soon be decentralized in some manner. In talking to sites, I feel they also have a broader acceptance of these tools. That acceptance by sites makes it much easier for us to implement them.”
Laulajainen cites eSignature as one example of the greater acceptance of emerging technologies. In the past they could not be used in many countries, but today they are accepted in all the countries in which UCB operates. Prior to the pandemic, Laulajainen believes 30 percent of patients in the U.S. and 10 percent in Europe noted having experienced a televisit. Today he believes those numbers have risen to over 60 percent in the U.S. and 30 percent in Europe.
“Those numbers have exploded,” he says. “Now that patients have experienced the convenience, I don't think there is any turning back. The numbers may go down a bit after the pandemic, but those type of visits will not go away.”