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Should Sponsors Share Site Feedback?

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Manage episode 503184911 series 3506216
Content provided by Darshan Kulkarni. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Darshan Kulkarni or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

Darshan Kulkarni and Edye Edens examine whether sponsors should provide feedback to clinical trial sites on why they were selected—or not—for a study. While it is technically possible for sponsors to share this information, they caution that doing so carries significant risks. These include liability concerns, potential miscommunication, and the practical challenge of managing feedback when dozens of sites may be competing for the same study.

Darshan and Edye note that while most trials—such as common therapeutic areas like hypertension, diabetes, or general oncology—offer little incentive for sponsors to provide detailed feedback, there are exceptions. Trials in rare diseases or highly specialized therapeutic areas often involve fewer qualified sites, making strong relationships and clear communication more strategically valuable. In these cases, feedback can help sites understand expectations, improve their performance, and strengthen their ongoing relationship with the sponsor.

Ultimately, both emphasize that the decision to provide site-specific feedback must balance potential benefits with practical realities and legal risks. For the majority of trials, the challenges and liability concerns outweigh the advantages, but in carefully chosen scenarios, structured and thoughtful feedback can support site development and long-term collaboration.

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265 episodes

Artwork
iconShare
 
Manage episode 503184911 series 3506216
Content provided by Darshan Kulkarni. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Darshan Kulkarni or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

Darshan Kulkarni and Edye Edens examine whether sponsors should provide feedback to clinical trial sites on why they were selected—or not—for a study. While it is technically possible for sponsors to share this information, they caution that doing so carries significant risks. These include liability concerns, potential miscommunication, and the practical challenge of managing feedback when dozens of sites may be competing for the same study.

Darshan and Edye note that while most trials—such as common therapeutic areas like hypertension, diabetes, or general oncology—offer little incentive for sponsors to provide detailed feedback, there are exceptions. Trials in rare diseases or highly specialized therapeutic areas often involve fewer qualified sites, making strong relationships and clear communication more strategically valuable. In these cases, feedback can help sites understand expectations, improve their performance, and strengthen their ongoing relationship with the sponsor.

Ultimately, both emphasize that the decision to provide site-specific feedback must balance potential benefits with practical realities and legal risks. For the majority of trials, the challenges and liability concerns outweigh the advantages, but in carefully chosen scenarios, structured and thoughtful feedback can support site development and long-term collaboration.

Support the show

  continue reading

265 episodes

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