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Unpacking Screen Fail Payments in Research

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Manage episode 486011732 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://ppacc.player.fm/legal.

In this episode Edye Edens and Darshan Kulkarni tackle a hot-button issue in clinical trials: Should all screen fails be paid for? The discussion was sparked by a recent wave of community questions and contract examples around this very topic.

From the sponsor’s perspective, concerns center around cost control and compliance. Sponsors fear that paying for every screen fail, without oversight, opens the door to unlimited financial exposure—and more dangerously, potential kickback violations. They emphasize the need for fair market value, capped budgets, and data-driven estimates of expected screen failure rates.

From the site’s perspective, there’s agreement: not all screen fails are avoidable, especially when a patient appears eligible but fails due to factors like lab results or genetic markers. Sites aren't asking for a blank check—they're asking for reasonable compensation when they've performed due diligence.

Together, we explore:

  • Why defining a “well-intentioned” screen fail matters.

  • How scientific and protocol-driven caps can align sponsor and site expectations.

  • The role of legal and clinical experts in designing fair, compliant agreements.

  • The compliance risks, especially under increased federal scrutiny in healthcare fraud.

  • Why sites must talk to their PIs and be empowered to negotiate using data—not just accept arbitrary screen fail caps.

Ultimately, this episode calls for collaboration, transparency, and data-backed contract terms. By using available science and engaging clinical and legal expertise, sponsors and sites can protect patients, stay compliant, and build long-term trust.

Support the show

  continue reading

233 episodes

Artwork
iconShare
 
Manage episode 486011732 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://ppacc.player.fm/legal.

In this episode Edye Edens and Darshan Kulkarni tackle a hot-button issue in clinical trials: Should all screen fails be paid for? The discussion was sparked by a recent wave of community questions and contract examples around this very topic.

From the sponsor’s perspective, concerns center around cost control and compliance. Sponsors fear that paying for every screen fail, without oversight, opens the door to unlimited financial exposure—and more dangerously, potential kickback violations. They emphasize the need for fair market value, capped budgets, and data-driven estimates of expected screen failure rates.

From the site’s perspective, there’s agreement: not all screen fails are avoidable, especially when a patient appears eligible but fails due to factors like lab results or genetic markers. Sites aren't asking for a blank check—they're asking for reasonable compensation when they've performed due diligence.

Together, we explore:

  • Why defining a “well-intentioned” screen fail matters.

  • How scientific and protocol-driven caps can align sponsor and site expectations.

  • The role of legal and clinical experts in designing fair, compliant agreements.

  • The compliance risks, especially under increased federal scrutiny in healthcare fraud.

  • Why sites must talk to their PIs and be empowered to negotiate using data—not just accept arbitrary screen fail caps.

Ultimately, this episode calls for collaboration, transparency, and data-backed contract terms. By using available science and engaging clinical and legal expertise, sponsors and sites can protect patients, stay compliant, and build long-term trust.

Support the show

  continue reading

233 episodes

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