The effects of releasing early results from ongoing clinical trials

Sharing early evidence, as a trial is ongoing, is fundamental for both physicians and patients to make enrollment decisions. Here, the authors report the results of a simulation study evaluating the potential effects of early release of interim efficacy and safety data on the duration and validity o...

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Bibliographic Details
Main Authors: Steffen Ventz, Sergio Bacallado, Rifaquat Rahman, Sara Tolaney, Jonathan D. Schoenfeld, Brian M. Alexander, Lorenzo Trippa
Format: Article
Language:English
Published: Nature Publishing Group 2021-02-01
Series:Nature Communications
Online Access:https://doi.org/10.1038/s41467-021-21116-4
Description
Summary:Sharing early evidence, as a trial is ongoing, is fundamental for both physicians and patients to make enrollment decisions. Here, the authors report the results of a simulation study evaluating the potential effects of early release of interim efficacy and safety data on the duration and validity of an ongoing clinical trial and demonstrate that positive interim results may shorten trial duration through increased enrollment.
ISSN:2041-1723