Shiny, new technologies and innovative best practices won’t maximize clinical trial improvement opportunities unless the people actually conducting the trials are engaged and educated, members of a panel discussion told attendees of the DIA 2018 Global Meeting June 27 in Boston.
“Methodology and technology are exciting developments,” says Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). “But we need to recognize people in the process. It’s an important part of the equation.”
In tandem with the multi-stakeholder group Clinical Trials Transformation Initiative (CTTI), ACRP is working to develop standards and certifications designed to ensure the highest possible clinical trial workforce quality. In recent years, ACRP, CTTI, and others have been especially active advocating for, vetting, and accepting new standards and certifications that will help advance the practice of clinical trials on a number of levels. The latest CTTI recommendations are slated for release in the fall, Kremidas says.
CTTI comprises more than 80 organizations from across the clinical trial enterprise. Members include representatives of government agencies, industry representatives, patient advocacy groups, professional societies, investigator groups, academic institutions, and other interested parties.
The time to act is now, Kremidas adds. As an example, he cited the consistently high turnover rate for so-called “one and done” principal investigators who discover after the fact they aren’t ready to conduct a trial and drop out as soon as they can. “As an industry, we’re not doing a good job preparing them,” Kremidas says.
Further evidence: The issues cited by the U.S. Food and Drug Administration in clinical trial Warning Letters and FDA Form 483s (Inspectional Observations) are the same year in and year out. “Nothing changes except the date,” Kremidas says. “We’re not making progress.”
“There are lots of new tools, but people often are not aware of them,” says Stella Stergiopoulos, research fellow at the Tufts Center for the Study of Drug Development, also noting that the clinical trial industry remains stubbornly “fragmented.” An inadequate sharing of ideas and inability to establish standards makes it harder for sponsors and sites to develop anything remotely like consistent ways of conducting trial business.
“We need to do more to help clinical trial practitioners improve their technology acumen,” Kremidas says.
Human collaboration and coordinated harmonization efforts by technology providers remain the “best way we have to achieve the promise of technology,” says Claire Sears, communications director for data solutions at DrugDev.
A recent survey by Veeva found that a large pool of clinical operations professionals is seeking greater unity. Their top drivers for unification include the potential for improving visibility and oversight (77%), enabling faster study execution (67%), and improving study quality (62%).
Variance is an enemy of quality, Kremidas says. “There is no standard way to become a study coordinator,” he points out. The result? While there are many well-trained and talented coordinators, the entrance point is so random it undermines efforts to improve clinical trial performance, he says.
Many coordinators are former nurses who tend to thrive as coordinators, Kremidas notes, but others enter in a haphazard way. “Sometimes it’s a receptionist who moves into the role simply because they are around, and the site needs someone,” he says.
Author: Michael Causey