Is it Time to Hit the Clinical Trial ‘Reset’ Button?

Kenneth Getz, MBA, Deputy Director and Professor, Tufts Center for the Study of Drug Development

The future of clinical trials has arrived. Are you ready? That’s the message from thought leader Ken Getz, deputy director and professor with the Tufts Center for the Study of Drug Development at Tufts University School of Medicine and founder and board chair of the Center for Information and Study on Clinical Research Participation.

“Think about how we operated as a clinical trial industry pre-COVID pandemic,” Getz says. “Think of the barriers to collaboration and innovation we’ve removed” as the industry has united on an emergency footing to use “all available tools” to battle a historic health crisis. “Patients and practitioners are more readily approaching remote clinical trials,” Getz says.

In fact, the coronavirus crisis has jolted the traditionally slow-to-adopt clinical trial industry and “mobilized everyone,” Getz says. “We’ve been in a perpetual [automatic] pilot mode” for years when it came to circling around—yet never fully embracing—tools to promote remote monitoring and decentralized clinical trials, he says.


Assessing Today’s Drug Development Operating Environment: Time to Hit the Reset Button?

Join Getz Friday, April 17 for his Virtual ACRP 2020 session exploring the anticipated long term effects of global change and response to the coronavirus pandemic. Getz will also examine major trends impacting the operating environment for new drug development including evolving pipelines, players and executional models.

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Well, the future is now and there’s no turning back, Getz suggests. “I’m very inspired and encouraged by how stakeholders have embraced” new technologies and best practices, he says. He applauds regulatory leaders who have “relaxed or changed” standard operating procedures to meet a greater sense of urgency to battle COVID-19.

Looking ahead to a time when the disease is abated or eradicated, Getz believes many of the innovations the clinical trial industry adopted under some duress will remain in place. For one thing, in the months ahead the industry is going to be able to examine data based on real experience with remote and other innovative technologies, he says.

“We’ll have harder data to see how [these innovations] performed during the pandemic,” Getz notes. His prediction: The new technologies and practices won’t necessarily prove to be “better” than traditional ways of conducting trials, but they will demonsrate they are “doable and feasible” in many situations industry hadn’t heretofore recognized.

“I think new technologies and ideas, instead of being partitioned off to the side as they once were, will be considered more willingly as options,” Getz says.

Author: Michael Causey