Why Clinical Trials Shouldn’t be Run as a Sideline Business

Steven Ziemba, PhD, CCRC, CPI, FACRP, Associate Director, Marshfield Clinic Research Foundation

Steven Ziemba, PhD, CCRC, CPI, FACRP, Associate Director, Marshfield Clinic Research Foundation

Healthcare providers, especially community-based providers, too often approach clinical research as a sideline business—to the detriment of patient safety and financial reward, says Steven Ziemba, PhD, CCRC, CPI, FACRP, lead IRB reviewer and assistant professor at Northcentral University.

Instead, clinical research should be its own service line, Ziemba says. “It requires resources in and of itself,” he notes. Approached properly, it can be “a very lucrative avenue from a revenue perspective.”

There are many differences between healthcare and clinical trials. Those distinctions aren’t always recognized by new entrants. “A clinical trial is science,” and it’s intended to generate knowledge, Ziemba points out. Informed consent must clearly outline what benefits the patients may or may not receive, and “a patient who is on a clinical trial is going to be watched more closely than your traditional patient,” he adds.

The potential new line of revenue is attractive, of course, but a patient’s well-being must always be the top priority in a trial. However, “an organization that is only doing clinical research and not putting the resources into it is jeopardizing patient safety,” Ziemba warns. In many cases, those conducting the trials may not even realize it, he says. “I’ve had many conversations with different healthcare administrators whose view on clinical research is, ‘Well, it’s run the same way as you would healthcare.’ And that’s not true,” he notes. “But they don’t know that.”

Back from the Brink: Rescuing a Clinical Research Site – Join Ziemba Monday, April 30 during ACRP 2018 and explore how sites might find themselves performing poorly and ways to identify what is and isn’t working. Learn how to take corrective actions and solidify those actions into a research program focus on quality. Learn More

There are several ways to ensure that a new clinical trial practice is infused with the appropriate financial and staff resources, says Ziemba, who is also founder and principal of Research Site Consult, LLC and a former Chair of the Association Board of Trustees for ACRP. He suggests that an effective way to start is to identify a practice, such as informed consent, and make a side-by-side comparison of the differences in that practice between standard healthcare and clinical research. “Look at what’s required for each,” he says, and use that comparison to identify whether your organization is prepared to enter the clinical trial business, and to address areas where you need new resources.

Author: Michael Causey