Failure to address clinical trial recruitment issues at the outset continues to plague sites, according to the findings of a new task force. Result? Nearly 40% of clinical trials fail to meet recruitment goals, says Elizabeth Mahon, JD, associate director of Global Clinical Operations – U.S., Janssen R&D.
“Recruitment planning too often is an afterthought,” Mahon says. She’s part of a Clinical Trials Transformation Initiative (CTTI) Recruitment Project team that drew upon representatives covering the entire gamut of trials, including Food and Drug Administration officials, patient advocates, investigators, study coordinators, and others to get a full picture of the state of the clinical trial industry. It’s not always a pretty picture.
For example, there are no consistent recommendations or frameworks for conducting recruitment planning across disciplines, Mahon says. That’s a significant problem for those in academia and other sectors who essentially have to start over again each time they focus on recruitment planning, she adds. Providing a framework will help make certain key considerations such as patient rights are front-of-mind from the earliest stages of planning, Mahon says.
It’s all part of building a bigger tent when first considering a patient recruitment strategy and subsequent tactical plan. One key is to identify and engage all stakeholders from the very beginning, Mahon says. “Too often it is just sponsors and some key opinion leaders” sitting at the table, she notes. Instead, she advises including others—such as clinical researchers—to make planning more holistic.