Accreditation Can Enhance Clinical Trial Quality

James Riddle, MCSE, CIP, CPIA, CRQM, Vice President, Research Services & Strategic Consulting, Advarra

Even in the futuristic universe of the Star Trek franchise, Dr. McCoy, Nurse Chapel, and other “carbon-based units” remain vital to providing healthcare to space-faring crews, while technology remains their faithful servant and helper. For James Riddle, vice president of institutional services and strategic consulting for Advarra, and with tongue slightly in cheek, that’s not a bad way for clinical trial practitioners to look at the rise of technology in their field.

“Some clinical trial procedures will always be done in person, and some trials will never be 100% virtual,” Riddle says. “The clinical research coordinator (CRC) and principal investigator (PI) roles aren’t going away anytime soon,” he adds, noting human clinical trial practitioners will remain integral to operations for years to come.

As one of the first professionals to become certified as a Clinical Research Quality Manager (CRQM), Riddle now serves as Chair of Accreditation Protocols for SASI Accreditation and is naturally a big fan of accreditations to help advance clinical trial quality.

“The CRQM certification is focused on how to design and support a culture of quality and a ‘zero defects’ attitude in clinical trials,” Riddle says.

However, Riddle also has news for clinical trial practitioners who are wary about embracing new technology. “Remote trials technology is here to stay [and] will only grow in usage” in the months to come, he predicts. “CRCs, PIs, and others better prepare for the changes and learn to roll and adapt.”

If Star Trek generally presents a positive view of the future, another sci-fi classic, Stanley Kubrick’s 2001: A Space Odyssey, presented a future where machines wrest for control with their human inventors. That’s not going to happen in clinical trials, Riddle says.

“Artificial intelligence (AI) in clinical research is advanced machine learning at best today,” Riddle notes. Technology can help human professionals better and more quickly analyze data, and remote tools are making it easier for some patients to participate in trials they might otherwise have passed on years ago, he adds.

Leveraged properly, remote trial technology will most likely “improve diversity and consistency” in clinical trials, even as it also strengthens enrollment by lowering the patient drop-out rate and allowing access to trials for previously underserved participants, Riddle says.

The rapid development and growth of advanced technologies, machine learning, and the often mischaracterized AI have significantly increased the need for research staff with multidisciplinary or multilayered competencies.

As Riddle sees it, it’s time for training and for sites to catch up to the new realities for the clinical trial workforce. Looking at sponsors and contract research organizations, Riddle says both “need to do a better job of allowing sites and locations to use technology the best way it works for them, and not [necessarily bowing] to what the sponsor wants.” Too often, he says, sponsors select and impose a technology on CRCs. “It’s untenable the number of systems CRCs have to navigate today,” he adds.

In terms of training, the clinical trial workforce needs and deserves new kinds of offerings, Riddle says. “CRCs need to be trained to be able to understand how technologies work and become good tech support to the patients who will be using them,” he stresses.

Author: Michael Causey