Nearly half of all so-called “one and done” principal investigators who retreat from clinical research after conducting a single study want back in if they can find resources and advice to help on their second attempt, according to findings from a new Clinical Trials Transformation Initiative (CTTI) survey and recommendations project.
“We assumed when we surveyed the one and done investigators that they threw their hands up…because it was too frustrating, too difficult, and so they just walked away,” says Gerrit Hamre, a CTTI project manager. Instead, 44% said they wanted to conduct more trials with a little direction.
“It’s hard for investigators to get into trials with so little support and guidance on how to do it,” Hamre says. “Trials have become so difficult over the last couple decades, it’s almost a miracle that anyone gets past that one and done part.”
Another survey surprise: “You don’t have a composite anywhere of tools and recommendations” on how to address complex clinical trial challenges and operations, Hamre says. “Folks go through Good Clinical Practice training and all these other activities to try and become investigators, but from what we see, most of the [prep] work…isn’t focused on the nuts-and-bolts administrative work, infrastructure, or [budgeting details]” needed for a study to prosper, he adds.
CTTI has crafted many of its recommendations to address such shortcomings, Hamre said. About 80% of the recommendations are geared toward investigators. Among the recommendations:
- Hire and retain well-trained, experienced research coordinators and other essential staff. Seek employees with regulatory affairs expertise, budget and contracting knowledge, and patient recruitment expertise, among other skills.
- Provide continuous training for research staff. Targeted training specific to clinical research must include all staff involved in clinical research activities, not just the investigator. “Participation is paramount,” CTTI says.
- Guide clinical research practice at the site with standard operating procedures (SOPs) and systems. CTTI advocates written SOPs and the organization of study-related procedures and tasks based on pre-study, study start-up, study execution, and close-out milestones.
CTTI also provides recommendations to investigators on how to optimize trial execution and conduct, and tips for better site budgeting and contract negotiations.
Author: Michael Causey