Kunal Sampat, MNA, senior manager for Clinical Trial Programs at Abbott Vascular believes that data should lead the way it comes to site selection. He says, “let data drive your site selection decisions” and “don’t support lousy site seletion.”1
His other tips include:
- 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.
Sampat reiterates the importance of addressing screen failure issues before the process is too developed. Additionally, he encourages a robust program to develop a solid protocol template and incorporate standard I/E criteria in every protocol. Lastly, existing templates from sources such as FDA can help determine standard safety definitions from your specific therapeutic area.
Sampat recommends that you take the time to “talk to sites, research coordinators, and site investigators, and to conduct regional meetings with site staff” when researching potential sites. 1
He also advises to find I/E criteria for completed and current trials of your competitors to “get ideas and identify gaps in your protocol.”1 Furthermore, the right culture can help. A culture that would frown upon protocol amendments. In other words, 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.
Pearl IRB offers a variety of services to meet your needs including site monitoring, site assessment, site rescue/remediation and auditing. To learn more, click here.
1 https://www.acrpnet.org/2017/07/17/avoiding-lousy-site-selection-decisions/