This is an excerpt from Medically Necessary, a health care supply chain newsletter. Subscribe here.
The trend: During the COVID-19 pandemic, many drug researchers had to suddenly modify clinical trials to include remote elements, like direct-to-patient drug shipments or video call consultations.
Industry leaders say these kinds of decentralized clinical trials grew rapidly in 2020. Now, the pharmaceutical industry is adopting many of those techniques more permanently.
That could make it easier for patients to participate in clinical trials, but getting all the necessary supplies to a patient’s home will be a major logistical challenge.
Background: Most clinical trials are based at research sites. Patients travel to those sites to receive treatments and researchers collect data there.
Clinical trials have long included low-tech remote components, such as diaries that allow patients to record symptoms at home.
The Food and Drug Administration doesn’t have a formal definition for decentralized trials yet. But a useful working definition includes any studies with trial activities that happen without an investigator physically present.
“There was no need for a bright line to identify a decentralized clinical trial (DCT). However, with advances in information technology, telehealth and the increasing use of digital health technologies … there is increasing recognition that DCTs are becoming a distinguishable entity,” an FDA spokesperson said via email.
Growth: In 2020, a team from Harvard and the health-tech company Elektra Labs tried to quantify the growth of decentralized clinical trials in a paper published in Nature.
They found that the use of remote sensors in clinical trials increased tenfold from 2000 to 2018. The rate of growth appeared to increase in 2008 when the iPhone was introduced, the research team noted.
Andrea Zobel, senior director of personalized supply chain at the AmerisourceBergen subsidiary World Courier, measured the number of trial drugs shipped directly to patients as another way to track the growth of decentralized trials.
Before the pandemic, fewer than 5% of shipments of trial drugs went directly to patients, Zobel said.
But the practice was growing. Shipments doubled each year leading up to the COVID-19 pandemic. Then the number of shipments exploded.
Zobel estimated that direct-to-patient shipments of trial drugs increased fourfold during the pandemic.
The pandemic: Decentralized components became a part of every conversation with customers for Slope, a company that helps manage supply chains for clinical trials.
“Some of those ‘nice-to-haves’ or ‘one-days’ became, ‘we have to do this now,’” Slope solutions architect Ethan Seville told FreightWaves.
In the spring of 2020, the FDA started encouraging researchers running clinical trials to adopt remote techniques to avoid exposing patients to the virus.
Mustafa Khasraw, a cancer researcher at Duke University Medical Center, had to adapt his studies to protect patients last year.
“We’ve been forced to do things differently and be creative and come up with new approaches to challenges,” Khasraw told FreightWaves.
Normally, Khasraw would have patients coming to his research site from all over the country. During the pandemic, he used telehealth to reach those people. He believes that’s progress.
“I think having the option of doing decentralized trial activities, not the entire trial, is a huge win for patients,” he said.
The promise: Those types of conveniences are exactly why drug companies are interested in continuing the use of clinical trials. Fewer site visits could make it easier, and cheaper, to enroll patients.
“It’s all about recruitment and the enrollment of patients in clinical trials,” Zobel said. “It’s extremely time critical to run clinical trials because … the pharmaceutical companies want to bring it to market.”
Using remote sensors to take measurements in patients’ homes can also offer more complete data, according to Christine Manta, head of applied sciences at HumanFirst. HumanFirst helps drugmakers select remote sensors for clinical trials.
“What used to be just snapshots of data, moments in time of health, now we can get almost a movie, 24 hours of continuous measurement,” she told FreightWaves.
The challenge: Even before the widespread adoption of decentralized elements, supply chains for clinical trials were not usually efficient, according to Slope CEO Rust Felix.
“Your local 7-Eleven has a supply chain that is far more performant than the most cutting-edge clinical trials,” he told FreightWaves. “It’s mind-boggling.”
Shipping investigational drugs directly to patients, rather than a centralized research site, will be a much bigger challenge. But Felix believes it may also be an opportunity to professionalize these supply chains.
“I think [decentralized trials] … are going to force everyone to up their game and we think that’s a fantastic thing,” he said.
Zobel said that 2020 may be an excellent trial run. It forced drug companies and investigators to get experience running decentralized trials. Now, they can use that experience to make them better.
“These trials had been shifted to a decentralized model during an emergency situation. They’re not planned,” she said. “It’s different when we are… setting up decentralized trials with the right technology support and well-developed processes.”
What’s next? With more than a year of experience running remote trials and more detailed guidance from regulators, many organizations are eager to move forward with more decentralized trials.
The New Jersey software company Castor recently raised $45 million to scale up direct-to-patient trials globally. Marken, a UPS subsidiary, recently announced a partnership with a technology company to expand offerings related to decentralized trials.
An FDA office focused on cancer research is now asking companies applying for drug approvals to voluntarily flag studies in which the data was collected remotely. The agency hopes to study the effects of remote assessments conducted during the pandemic so it can appropriately promote these trials going forward.
Manta said she believes the pandemic has built momentum for the use of digital measurements in clinical trials. Drug companies now have more confidence that trials using these digital technologies will be valid and successful.
“There’s no way we’re ever going to turn it around,” she said. “We’re going to get to the point where a digital endpoint is … just an endpoint that happens to be collected at home.”
Patients are also likely to demand that clinical trials offer more remote elements, Khasraw said. Now that they’ve seen how telehealth can reduce travel and make it easier to participate in trials, he doesn’t think they’ll want to go back.
“We’re not going back to the same pattern of practice before the pandemic,” he said. “We’re going to continue to use the remote monitoring, remote clinical trial activity, and we’ll continue to take advantage of the technology.”