Covid-19 created a shift in the delivery of clinical trials, allowing for participants to access trials outside of a traditional research site, thus expanding the scope of clinical trials.
That was the message shared by Claudia Lucchinetti, director of Mayo Clinic Center for Clinical and Translational research, Tuesday at the Mayo Clinic Platform Conference.
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At the conference, Lucchinetti discussed the transformation to decentralized clinical trials, which is a clinical trial that is completely conducted virtually through telehealth technology. This compares to a fully centralized clinical trial model, where the trial is conducted at an academic medical center or large community-based center. There is also a hybrid model that uses components of both decentralized and centralized models.
“Covid brought us directly into the hybrid state and even the fully decentralized state for some trials,” Lucchinetti said.
Hybrid and DCT models created several benefits, Lucchinetti said, including a 1.3 to 2 times faster enrollment rate than centralized models. Additionally, they could have up to a 90% higher retention rate than centralized models, she said.
In a centralized model, “many will drop out,” Lucchinetti said. “It’s quite a burden for many patients to travel to a site.”
The timeline for starting the trial also may be shorter for decentralized and hybrid models than centralized. For traditional trials, the process may take three to nine months, whereas it may take two to four weeks for hybrid and decentralized models.
Other than transportation and time taken to travel to a trial site, patients face many barriers when it comes to clinical trials. Many are simply unaware of the trials, are afraid of what they don’t know about the trial, are afraid of the side effects and are concerned about the costs. These concerns are part of what is driving the change to decentralized and hybrid models.
“Many of these burdens could potentially be to some extent mitigated in a decentralized or hybrid environment,” Lucchinetti said.
These types of more accessible trials could also accelerate inclusivity, according to Lucchinetti. Black people make up 13% of the American population, but are less than 5% of clinical trials. Hispanic people are about 18% of the American population, but less than 1% participate in clinical trials, she cited.
There is growing evidence that patients are also in favor of decentralized trials, she said citing a survey of cancer patients. In the survey, 58% said traveling is a barrier for trials, and 63% said a remote trial option would make them more likely to participate. Additionally, 62% said they would be more likely to participate if they can complete surveys or patient diaries for the trial at home.
In response, sites are rapidly adopting decentralized clinical trial solutions. Right now, 89% of sponsors for clinical trials use decentralized elements in at least some of their trials and 92% of hospitals and health systems use decentralized models. However, academic medical centers are slower in this adoption, with only 40% using this model, according to Lucchinetti.
Despite the popularity, it’s not as if DCT trials will replace traditional models, especially for complex services. However, patients need to be given some flexibility.
“We need to be mindful of offering patients a choice in what they want,” Lucchinetti said. “Some may prefer to be in the traditional bricks and mortar site versus a decentralized site.”
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