1. Implications of product withdrawal on a post-approval pragmatic trial: The VOLUME Study Experience
- Author
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Kolitsopoulos, Francesca M., Gatto, Nicolle M., Sweetland, Kevin, Bracken, Michael B., and Jackson, Neville
- Abstract
Many clinical trials terminate early due to safety and efficacy concerns, and less often due to unexpected “positive” findings. However, early termination of post-approval (Phase IV) pragmatic randomized trials for commercial reasons is less frequent, may be more complex, and may require added flexibility in closure methods, including short term follow-up. VOLUME was a randomized, open-label, post-approval pragmatic clinical trial (PCT) or large simple trial that terminated early due to product withdrawal. The aim of this paper is to describe circumstances unique to post-approval PCTs that may require a closure amendment rather than immediate study termination, and our recommendations for operational study closure in these circumstances. We use the VOLUME case study throughout to provide a practical example.
- Published
- 2024
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