With drug and device manufacturers and the U.S. Food and Drug Administration (FDA) supplying much of the push, so-called paperless clinical trials are gaining momentum in an industry not noted for early adoption of technology, says Jules Mitchel, MBA, PhD, president of Target Health Incorporated.
“There are a lot of initiatives from Big Pharma” centered on paperless trials, Mitchel says. In addition, he notes that “FDA has been crystal clear” that it’s behind the trend, and the agency has done a good job of telling industry what it expects from a regulatory standpoint.
A common and long-standing complaint among healthcare industry actors is FDA’s lack of clear direction, especially with new initiatives. In many cases, healthcare companies are reticent to embrace a new way of operating because they fear they’re not doing what the FDA will ultimately demand. That’s not a valid excuse when it comes to paperless clinical trials, Mitchel says, noting that “FDA is not the bottleneck.”
Going Paperless: Remote Monitoring, Regulatory and Patient Documents, and Documentation of PI Oversight – Take a deep dive into paperless trials at this ACRP 2018 workshop next month. Explore issues sites might face in making the move to paperless and their potential solutions, see interactive demonstrations of paperless subject chart creation and address adverse event adjudication, investigator oversight, electronic binder organization, remote monitoring facilitation, and more. View Session Details
In addition, Mitchel says FDA is responsive when asked for input on a clinical trial design incorporating mobile tools and the like. He suggests taking advantage of this by requesting a meeting with the agency; but being proactive. “Don’t ask them what you should do,” he says. Instead, thoroughly outline the protocol and encourage agency feedback.
“You still have to design a good protocol,” Mitchel says. The “protocol has to be [about] really understanding the drug or the device or biologic. [It] becomes a tool in the process.”
Too often, Mitchel says, clinical trial sponsors are afraid of asking FDA to examine protocols. That’s a mistake. “Don’t be afraid to ask” during those meetings, he says. If the protocol is grounded in science and demonstrates a basic understanding of the regulations, FDA is open to working with the sponsor. “They may not always agree with you, but usually they will if it’s well thought out,” he says.
In some cases, FDA might ask for a small study first—to help the agency understand the sponsor’s approach. “In general, I would say don’t be afraid to ask,” Mitchel notes.
Author: Michael Causey