GRAND RAPIDS, Mich. (WOOD) — If there is a silver lining to the COVID-19 pandemic, it could be the technological advances made in a short period. Communication on a macro- and micro-level changed, allowing people to connect remotely in more ways than ever before. The U.S. Food and Drug Administration believes those advances can be brought to the research realm, too.
Earlier this year, the FDA announced new guidance and recommendations for decentralized clinical trials. Typically, clinical trials are conducted using patients near a research facility — whether that be a local hospital or university. That still regularly requires patients to travel long distances or find lodging to participate. Both factors limit who can take part in the study and heavily skews toward people who live in urban areas or close to research facilities.
“Decentralizing clinical trials will allow some or all trial-related activities to take place at trial participants’ homes or other convenient locations, instead of having them visit research sites,” the FDA said in a statement.
In addition to expanding access, the FDA believes decentralized clinical trials will be more efficient and advance medicine faster because they should be more successful. That means less wasted time and wasted funding.
A study published in May in “Therapeutic Innovation & Regulatory Science” says only 7.9% of clinical trials are considered a success, 19% of clinical trials go unfinished because researchers cannot assemble enough participants. And 80% of clinical trials either fail to meet their enrollment standards or run longer than anticipated because of enrollment issues.
Dr. David Kaufman, the assistant vice president of clinical affairs for Michigan State University, believes decentralized clinical trials make a lot of sense for certain projects.
“It’s more real-world. Many times it is conducted closer to home, occasionally in the home, and it allows for a wider diversity of subjects,” Kaufman told News 8.
Kaufman believes travel is the primary reason many clinical trials fail.
“One out of five trials will fail based on the inability to recruit and retain patients. Many times that is due to travel, the inconvenience of that. Decentralized trials allows those obstacles to be overcome more easily,” he said. “With the use of a variety of technologies, some of which emerged during the COVID pandemic, it has allowed us to decentralize trials and move them closer to patients’ homes.”
An analysis by the FDA predicts decentralized trials could boost patient enrollment by 300% and drastically cut down trial timelines — some as much as 1400%.
For now, Kaufman said most of MSU’s clinical trials are still being conducted in-house, but he expects more trials to be decentralized in the coming years, saying it fits with the university’s ethos. MSU already has one decentralized study, gathering blood samples and data from people all across the state.
“There are hematology studies that are conducted in the Upper Peninsula and the northern part of the Lower Peninsula, allowing data acquisition in a way that is far more convenient for our patients,” Kaufman said.
But there are some drawbacks to decentralized trials, as well.
“There is better oversight in a centralized sort of study: medication distribution, data security, patient safety must also be a consideration. Centralized clinical trials provide better oversight. But it’s a balance. It’s a balance between speed, efficiency, real world versus better oversight of the data that is collected,” he said. “But as we enter the era of better connectivity, those obstacles, I think, will become easier to overcome.”