FDA Officials See Big Clinical Trial Changes on the Horizon

FDA Official Highlights Changes in Trial Settings, Devices, and More

“My prediction is that clinical trials in 10 years’ time will be very hard for us to recognize,” Leonard Sacks, MD, associate director for clinical methodology in the Office of Medical Policy at the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), told attendees of the agency’s Clinical Investigator Training Course this week in College Park, Md.

Sacks sees a lot of changes when he peers into the crystal ball. For starters, clinical trials will “occur at patients’ homes or at their private doctors,” and patients will wear “sensor devices, flash pictures of their lesions from their cellphones, submit patient-reported outcomes on their tablet computers, [and] perhaps even receive their study drugs by drone,” he said. “This is just the beginning” of a time of great change in the clinical trial world, he said.

Along with several other FDA speakers at the event, Sacks emphasized the agency wants to work closely with industry and is generally enthusiastically receptive to relatively new trends such as decentralized clinical trials (DCTs) and the leveraging of real-world evidence (RWE).

RWE has the potential to “improve the efficiency of clinical research by capitalizing on data that is being captured every day,” said David B. Martin, MD, MPH, a Captain in the U.S. Public Health Service, also with CDER’s Office of Medical Policy. In addition, he applauded its potential to help “close the divide between research and clinical care.” His optimism is fueled, in part, by the digitization of healthcare as a means to access more diverse patient populations, he noted.

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Martin also stressed the importance of understanding and harmonizing the usage of the terminology in play across the clinical trial spectrum. For example, RWE is defined by the FDA as “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of [real world evidence].”

Speaking of terminology, don’t call hybrid or virtual trials “siteless” around Isaac R. Rodriguez, PhD, MHSc, MSc, an FDA Officer for clinical research methodology, regulatory compliance, and medical policy development at CDER. “We don’t think that way,” he said. While saying he’s excited about the prospect of increased usage of DCTs in the proper circumstances, he added they “aren’t a universal solution.”

From the FDA’s regulatory perspective, the “site” in a so-called “siteless trial” is the address of the investigator in charge of the trial. “This is the place where the investigator conducts, oversees, and coordinates trial activities,” Rodriguez said.

The FDA wants to be supportive of new technologies, tools, and tactics, speakers stressed. “We want to help expedite and deliver [drugs] in a legal and safe way to the patients who need them most,” Rodriguez said.

Author: Michael Causey