New Regulatory Flexibility Driving Positive Industry Change

State of the Industry

An exciting regulatory willingness to consider new ways of clinical trial oversight is the single biggest factor driving innovations in the industry. That’s the assessment of Terri Hinkley, Workforce Innovation Officer for the Association of Clinical Research Professionals (ACRP).

“We’re a risk-averse industry,” she told attendees kicking off day two of ACRP’s 2017 Meeting & Expo in Seattle April 30. She singled out the Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council on Harmonization (ICH) for sparking industry to adopt new technologies and processes to make clinical trials more effective and patient-friendly.

The importance of patient-centricity ran throughout the panel discussion moderated by ACRP Executive Director Jim Kremidas. “There’s been a reawakening of the concept of putting the patient at the heart of everything we do,” said Ken Getz, Director and Associate Professor with the Center for the Study of Drug Development, Tufts University. “We’re seeing the galvanization of all stakeholder groups.”

Echoing Getz, Leanne Madre, Director of Strategy with the Clinical Trials Transformation Initiative at Duke University Medical Center, said industry must continue the trend of better engagement with patients by asking relevant questions and empathizing with the burden being place on many trial participants.

State of the Industry Panel

Some are hourly workers, added Elisa Cascade, President for Data Solutions with DrugDev, so some form of compensation must be built into the protocol to help defray lost income.

The panelists also addressed the plethora of data in clinical trials, including widespread use of electronic health records. “We expect this to rise,” Getz said.

Risk-based monitoring (RBM) was also a hot topic for the panel. While there continues to be some confusion about the exact definition, there’s been a clear uptick in some form of RBM usage in trials, Getz said. He cited a Quintiles study that found 63% of companies have implemented at least one aspect of RBM, up from 31% in 2011.

Author: Michael Causey