Unbowed by a litany of obstacles, including the increasingly difficult path to finding new patients and an aversion to maximizing new technology, a quartet of industry thought-leaders exuded optimism about the future of the clinical trial industry during an engaging panel discussion Monday morning (April 15) at ACRP 2019 in Nashville.
“We’re going to continue to raise the bar of awareness and understanding across industry, and I think it’s a message of hope,” said popular speaker David Burrow, PharmD, JD, from the U.S. Food and Drug Administration Center for Drug Evaluation and Research, where he is Director of the Office of Scientific Investigations within the Office of Compliance.
Panelists shared an optimism tempered by reality, though.
“We as an industry are notoriously bad at consuming advances in technology; we don’t do them in a way that perhaps other industries [including banking and aviation] do,” said Dalvir Gill, PhD, CEO of TransCelerate BioPharma, Inc. “Some of it is reluctance, but we’re also hampered by the fact that there are laws that we’ve created [that] create barriers that we have to systematically chip away.”
“You have to look at some of the new technology as an opportunity,” said Jamie Macdonald, CEO of PAREXEL International. While championing many flavors of technology and the value of hybrid virtual trials, Macdonald was quick to add that “sites are still pivotal. I think what we’re seeing is data doesn’t enroll clinical trials.”
In other words, data may tell us where patients are physically, but “it’s a very human process to engage with a physician, to discuss clinical trials as an option for their care, to consider consenting and screening, and then staying involved with the clinical trial,” Macdonald said.
And with more and more drug approvals considered to be precision medicine, finding and developing relationships with those patients is tough. “There is a more specific patient population [with] more inclusion/exclusion criteria, and therefore it’s harder to find new patients, screen them, randomize them…we’ve tried a lot of different ways, but we’re still stuck with old methodologies, intersecting with precision medicine and new technologies and digitalization,” Macdonald said.
“Finding subjects or patients is the single biggest challenge in the industry, and it’s going to get harder,” agreed John Neal, Founder and Chairman of PCRS Network, LLC, and Chair of the Association Board of Trustees for ACRP.
“I think there’s a lot of opportunity [and] a lot of hope as we continue to have these types of conversations with good folks from ACRP and all the individuals that come to this conference every year,” Burrow said. “It’s about learning, training, and growing. It’s going to help us to shorten timeline approval for patients.”
“The challenges are plenty, but I do believe there is light at the end of the tunnel,” Gill said.
Author: Michael Causey