Edye Edens and Darshan Kulkarni from KLF discuss the pros and cons for clinical trial sites considering becoming backup sites. Key points include: Sponsor Perspective: Signing up as a backup site can give first access to trials and increase the likelihood of being selected, especially since not all primary sites meet recruitment targets. Sponsors may expect some commitment, including potential startup or maintenance costs while waiting. Site Perspective: Some sites may worry about being seen as “second choice,” but having the capability to quickly operationalize a trial is a valuable skill. Sites can leverage backup status to position themselves as highly reliable and adaptable, potentially creating a niche opportunity. Fair Market Value Considerations: Sites keeping resources on hold may justify higher compensation than standard rates due to the cost of readiness. Sponsors might negotiate a middle ground to retain qualified, dependable sites. Best Fit for Backup Sites: Nimble, resourceful sites (often newer or smaller) benefit most. Large academic institutions may not be suited due to planning and resource constraints. Geographic or therapeutic focus can also influence suitability. Backup site models can be a win-win when structured properly, balancing site readiness, compensation, and sponsor needs. Sites and sponsors should carefully define terms, expectations, and fair market value for standby arrangements. Edye and Darshan encourage listeners to share experiences or questions via email or their website. Support the show www.kulkarnilawfirm.com
