“We’re all in the process of learning what [decentralized clinical trials] are about,” Isaac Rodriguez-Chavez, PhD, MHSc, an Officer for the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research in the Clinical Research Methodology, Regulatory Compliance, and Medical Policy Development area, told attendees of the Direct-to-Patient Clinical Trials conference sponsored by CBI in Philadelphia today (August 9). He also noted, however, that decentralized trials are generally not about retrofitting old ways of doing things onto a new template.
He also shared some good news from an oversight perspective, saying, “Don’t make it too hard on yourself. The [regulatory] standards are the same” for decentralized trials as they are for more traditional trial models.
Stressing that the concept of decentralized trials is not “necessarily new,” Rodriguez-Chavez said the FDA is broadly supportive of efforts to modernize clinical trial designs and clinical outcome assessments which will speed the development and review of novel medical products. The 21st Century Cures Act, signed into law December 2016, is expanding FDA’s regulatory work in the development of drugs, he added.
“The agency has worked closely with stakeholders, including the Clinical Trial Transformation Initiative, to identify innovative trial designs, evaluate the role of decentralized clinical trials and mobile technologies, and help validate novel endpoints that can enable trials to generate reliable evidence needed to assess product safety and efficacy more efficiently,” then-FDA Commissioner Scott Gottlieb said in March. Rodriguez-Chavez said FDA’s current Acting Commissioner, Dr. Ned Sharpless, shares Gottlieb’s pro-innovation philosophy as it impacts clinical trial design.
Working to clear up a source of common confusion, Rodriguez-Chavez stressed that decentralized trials are not “siteless trials.” In such trials, the “site” is the address of the investigator. “This is the place where the investigator conducts, oversees, and coordinates [decentralized trial]-related activities,” Rodriguez-Chavez said.
He also stressed the many advantages of decentralized trials, including leveraging the local healthcare network in a “real-world” environment. Such trials can harness the power of telemedicine and engage local healthcare providers, labs, and imaging services.
Bottom line: They may lead to “faster, less expensive trials,” Rodriguez-Chavez said.
Author: Michael Causey