Covid-19 has changed the way clinical trials are delivered, expanding the scope of clinical trials by allowing participants to access trials outside of traditional research sites.
Here’s the message shared Tuesday by Claudia Lucinetti, director of the Mayo Center for Clinical and Translational Research exist Mayo Clinic Platform Conference.
At the conference, Lucchinetti discussed the shift to a decentralized clinical trial, a clinical trial conducted entirely virtually through telehealth technology. In contrast, fully centralized clinical trial models are conducted in academic medical centers or large community centers. There is also a hybrid model that uses components of the decentralized and centralized models.
“Covid has taken us directly into a hybrid state, or even a fully decentralized state to do some experiments,” Lucchinetti said.
The hybrid and DCT models created several benefits, including 1.3 to 2 times faster enrollment than the centralized model, Lucchinetti said. Plus, their retention rates can be 90 percent higher than centralized models, she said.
In a centralized model, “a lot of people will quit,” Lucchinetti said. “For many patients, traveling to a site is a considerable burden.”
The time to start a trial is also much shorter for the decentralized and hybrid models than for the centralized model. The process can take three to nine months for traditional trials, and two to four weeks for mixed and dispersed models.
In addition to the time it takes to transport and travel to trial sites, patients face many hurdles in clinical trials. Many people don’t know the trial at all, are afraid of what they don’t know about the trial, are afraid of the side effects and worry about the cost. These concerns are part of what is driving the change in decentralized and hybrid models.
“Many of these burdens may be alleviated to some extent in a decentralized or hybrid environment,” Lucchinetti said.
These types of more accessible trials could also speed up inclusion, Lucchinetti said. Blacks make up 13% of the U.S. population, but less than 5% in clinical trials. She noted that Hispanics make up about 18 percent of the U.S. population, yet less than 1 percent participate in clinical trials.
There is growing evidence that patients are also Citing a survey of cancer patients, she said she favored decentralized trials. In the survey, 58% said travel was a barrier to trials, and 63% said the remote trial option would make them more likely to participate. Additionally, 62% said they would be more likely to participate if they could complete the trial’s survey or patient diary at home.
In response, sites are rapidly adopting decentralized clinical trial solutions. Currently, 89% of clinical trial sponsors use decentralized elements in at least some of their trials, and 92% of hospitals and health systems use decentralized models. However, academic medical centers have been slower to adopt this model, with only 40 percent using it, according to Lucchinetti.
Despite their popularity, DCT trials do not appear to replace traditional models, especially for complex services. However, patients need to have some flexibility.
“We need to pay attention to giving patients the options they want,” Lucchinetti said. “Some people may prefer to be on a traditional brick-and-mortar site rather than a decentralized site.”
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