A Proposed Confidence Ellipse Approach for Benefit-Risk Assessment in Clinical Trials.
In clinical development, an independent data safety monitoring committee (IDMC) is often established to ensure the test treatment's integrity, quality, safety, and efficacy under investigation. In clinical trials, IDMC may recommend stopping the trial early due to safety, futility/efficacy, or both...
| Publicado en: | Therapeutic Innovation & Regulatory Science Vol. 59; no. 3; pp. 606 - 619 |
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| Autores principales: | , , , , |
| Formato: | equations & formulas tables/charts Journal Article |
| Publicado: |
Springer Nature
May2025
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| Acceso en línea: | Ver este registro en EBSCOhost |