Changing a clinical trial’s statistical analysis plan on the cusp of a readout? That’s exactly what Alnylam just did for a closely watched study of its next-generation RNA interference therapy ...

Prior to the independent statistical group conducting any narsoplimab analyses, Omeros had received and incorporated FDA’s recommendations on the statistical analysis plan for the primary ...

Always plan early for analysis. The Data Analysis Plan is your next step once the Analytical Framework for your assessment has been defined. It's important that the people conducting the analysis ...

Under the adaptive statistical analysis plan, should the CardiAMP Cell Therapy for Heart Failure study be stopped early for anticipated efficacy at this, or any future DSMB review, study sites ...

Statistical Analysis Plan. In the second quarter of 2025, the Company held a Type B meeting with the FDA to discuss the proposed use of external control data and the prospectively defined ...