Clinical trial practitioners are far behind the learning curve when it comes to technology—and it’s not their fault, says Darlene Panzitta, president and founder of DSP Clinical Research, a contract research organization (CRO) specializing in services for small to mid-size pharmaceutical, biotechnology, and device companies in such therapeutic areas as infertility, women’s health, male hormone therapy, and endocrinology.
“The technology is moving a lot faster than we are,” Panzitta says. “The human component kind of got ignored along the way.” One of the main reasons, she says, is “we still do not have a standardized way of bringing in new study coordinators and clinical research associates [CRAs], which has resulted in a workforce shortage in those areas.”
Worse, in her view, certifications aren’t mandatory. Nurses and doctors must be certified. “We wouldn’t hire somebody who doesn’t have a license to do our trials from the MD perspective, but we let [CRAs and other trial practitioners] do it,” she says.
Panzitta calls on the U.S. Food and Drug Administration and sponsors to push for certification, saying, “I’d certainly appreciate it if we [devoted] 50% of the time we put into discussing technology and the turnover rates…into having a mandatory certification.”
She applauds ACRP’s certification program. “I think ACRP has developed a good test,” she says. “It’s challenging…it’s controlled and [ACRP] is a non-profit. I think we could have everybody certified within three to five years.”
Practitioners are the real force driving clinical trials, Panzitta says. “I feel like we have built a really nice house, we keep adding floors and expensive furniture, but we haven’t realized that this house we are keeping adding to has one big problem—the foundation is very old and outdated, and was never properly inspected,” she says. “Do we knock down this house and build a new one, or do we reinforce the foundation? We obviously can’t knock it down, so I am going with reinforcing the foundation.”
Voices from across the clinical trial spectrum continue to call for earmarking more resources into the human side of the clinical trials. Until then, our technology is waiting for us to catch up.
Author: Michael Causey