Decentralized clinical trials offer a chance to expand patient pools, obtain more data and — ultimately — move medicines and treatments to market faster. But sponsors worried about risks behind the technology driving decentralization don’t have to completely abandon traditional trials, according to CTTI.
“There is a broad continuum of hybrid approaches that provide sponsors and CROs with varying opportunities to implement decentralized trials, even if it is their first time doing so,” the group says in new recommendations urging drug developers to absorb fresh technologies into trials.
FDA and Duke University officials co-founded CTTI – and its recommendations are often curtain-raisers for FDA guidance. The group’s latest recommendations aren’t exactly revolutionary — most can be distilled down into the phrase “think ahead.” But they’re an effort to reassure a skittish industry that it’s possible — and even encouraged — for them to think creatively about clinical trials, CTTI Executive Director Pamela Tenaerts tells CenterWatch.
“There is this perception — and I think we’ve debunked that — that if you do trials in a decentralized way, there’s somehow a higher standard,” she says. “You just have to plan ahead.”
Trial costs have continued to grow — it now costs nearly $2.6 billion to get a single drug to market — even as information and communication technologies have gotten cheaper and better. This indicates the current clinical trial model simply isn’t sustainable, Tenaerts and her colleagues argue.
That doesn’t mean sponsors and CROs have to surrender their old ways completely, though. A traditional trial, for instance, might use local nurses or doctors to visit patients in remote areas, videoconferencing technology to talk to them or wearable devices to remotely monitor participants.
“There’s a real potential for patients with rare diseases to participate in clinical trials,” Tenaerts says. That said, sponsors and CROs will have to seriously consider which activities have to be done at sites, CTTI says. They’ll also have to make sure they comply with state and local licensing and telecom regulations, the groups adds, urging them to “invest in appropriate legal resources.”
For those sponsors or CROs who make use of local health aides, it’s also extremely important to consider — and to lay out early — which areas of care locals should oversee and which principal investigators should control.
“You probably want to be more conservative about that, especially early on in a trial,” Tenaerts says.
CTTI’s recommendations are a good first step, says Jill Johnston, president for site activation solutions at WCG.
Decentralized trials “are such a new thing for most of the industry” that most sponsors “are very hesitant to take a risk on their own studies,” she says. “They typically have a wait-and-see attitude when it comes to new thinking in this industry, especially in Phase II and III studies. They want to see proof that it works, ensure it will hold up to regulatory scrutiny.”
For now, sponsors are more likely to consider decentralized trials in post-market studies, Johnston notes. Nonetheless, the signs are unmistakable: clinical trials are moving toward decentralized trials, “albeit slowly,” she adds, stressing there’s no shame in them taking their time.
“In a traditional clinical study, there are literally 1,000-plus things that are all happening concurrently and need to be set up/standardization,” Johnston says. “Having to think through a new approach, as in a decentralized trial, would be very difficult if it is done within the confines of an individual study.”
Read recommendations here: https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/dct_recommendations_final.pdf.
-By Bill Myers