Sponsor-Initiated vs Regulatory-Initiated Closures
Sponsor-Initiated vs Regulatory-Initiated Closures Understanding Sponsor-Initiated vs Regulatory-Initiated Trial Closures Introduction: Two Pathways to Trial Termination Clinical trials can be terminated early for a variety of reasons. The termination may be sponsor-initiated, often due to strategic business decisions, interim safety or efficacy findings, or operational challenges. Alternatively, a trial may be regulatory-initiated, where agencies such…
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