Bolster Compliance Programs to Enhance Trials, Protect Patients

Kelly Willenberg

Dr. Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, Manager of Kelly Willenberg & Associates

Clinical research carries inherent risks at even the most accomplished sites, and it’s incumbent upon practitioners to be proactive and vigilant to better protect patients and operate more effective trials, says Dr. Kelly Willenberg, DBA, RN, CCRP, CHC, CHRC, manager of Kelly Willenberg & Associates.

While it may sound like it should be common sense, Willenberg says not everyone engaged in clinical trial research recognizes the hard reality of risk. “Sites need to be aware that participating in clinical research carries risk,” and site leaders need to design compliance oversight programs accordingly, she cautions.

“You can be reactive when it comes to compliance, but it can be expensive” if things go wrong, she notes. She advocates a more proactive approach.

The rise of hybrid and decentralized clinical trials (DCTs), while carrying many positives such as making it easier for more subjects to participate, has also created new areas of risk, Willenberg adds. For example, the lack of direct oversight in situations of remote monitoring and supervising makes it even more important to have strong compliance and risk management programs in place, she says.

Especially when it comes to DCT and hybrid trials, it is vital to have tangible, hands-on control of regulatory components, data collection, and other areas where patient safety and data integrity might be compromised by lax oversight. “We’re in a new place” with the rise of remote monitoring, and it’s time to “take a step back and assess what new risks” may have emerged, Willenberg says.

Successful compliance is also about securing buy-in from stakeholders, she adds. “You need to make certain [that those in a company’s] C-suite and upper management understand the importance of compliance” and management of risk, Willenberg says.

It’s also important to instill a “level of trust” with the clinical trial team, and create an environment where people feel comfortable stepping forward to ask questions or raise concerns, Willenberg says.

Compliance management “needs to be part of the conversation from the very beginning,” she says. “Your compliance officer needs to be an agent of change” who has a clear, holistic understanding of the complete clinical trial cycle, she adds.

Author: Michael Causey