When it comes to smart site selection, data should lead the way, says Kunal Sampat, MNA, senior manager for Clinical Trial Programs at Abbott Vascular.
“Let data drive your site selection decisions,” he told attendees of the Clinical Trial Protocol Optimization and Design Congress on July 17 in Philadelphia. “Don’t support lousy site selection.”
Among his other tips:
- Make sites complete your assessment questionnaire based on inclusion/exclusion (I/E) criteria.
- Demand data to determine the potential patient population at the site.
- Review data with study leadership. “Make no exceptions,” Sampat says.
It’s also important to address screen failure issues before the process gets too far down the road. Map out a screening and enrollment process and determine up front the time it will take for a site to identify a screen failure, Sampat says. Remember, “Sites want money for screen failures and sponsors don’t want to” shell out funds.
Sampat encourages a robust program to develop a solid protocol template and incorporate standard I/E criteria in every protocol. Don’t forget to include standard safety definitions from your specific therapeutic area. Finally, lean on existing templates from such sources as the U.S. Food and Drug Administration, National Institutes of Health, and TransCelerate Biopharma.
When researching potential sites, remember that questions are your friend. Take the time to “talk to sites, research coordinators, and site investigators, and to conduct regional meetings with site staff,” Sampat says.
Another tactic? “Spy on your competitors,” he says half-jokingly. For example, find I/E criteria for completed and current trials on ClinicalTrials.gov. This can help you to “get ideas and identify gaps in your protocol,” he advises.
The right kind of culture is a valuable tool, too, Sampat adds. A good one should “frown upon protocol amendments.” That means instilling a mindset that:
- Clearly states standard operating procedures for protocol reviewers as opposed to approvers.
- Monitors the number of amendments as a key performance indicator.
- Batches changes whenever possible.
- Sets financial goals for timely enrollment completion.
- Uses screen failure data to make protocol amendment decisions.
Author: Michael Causey