Savvy Consent Withdrawal Procedures Can Improve Trial Operations

Hubert Lesur, CCRC, CCRC, GCP-QA Auditor, HL Health Support

There’s an old marketing adage that complaining customers are to be cherished because they often can help you improve your product or service with their feedback. For Hubert Lesur, CCRC, a freelance Good Clinical Practice/quality assurance auditor and clinical research coordinator, the manner in which a clinical trial practice handles consent withdrawals offers a similar opportunity.

Lesur, who is also president of HL Health Support, based in France, urges clinical trial site staff to take the time to interview people opting out of a trial. “Spend time with them,” he says, to “understand why” they are leaving. Their answers can be illuminating. For example, people leaving the trial may be exposing a safety issue, or a badly written informed consent document.

“Get behind their decision” to learn how to improve your trial, Lesur says. Doing it properly “may assist sites and even sponsors in improving the operation and safety of a clinical trial,” he adds.

Lesur is also a big advocate of taking more time during the informed consent phase. “Fifteen extra minutes spent there thoroughly explaining” the trial can cut down on the number of participants who withdraw down the line, he says.

The COVID-19 pandemic has obviously changed how many trials operate, Lesur notes, and that’s especially true in areas of communication.

Consent withdrawals also present some thorny, and conflicting, data and regulatory challenges, Lesur notes. There are widely varying requirements for how to collect and share data received from patients who ask to leave a trial, he says.

“Junior staff in particular” would benefit from learning more about how to handle and process patient consent withdrawals, Lesur recommends.

Author: Michael Causey