Rethinking the Clinically Based Thresholds of TransCelerate BioPharma for Risk-Based Monitoring.

07:00 EST 1st January 2018 | BioPortfolio

Summary of "Rethinking the Clinically Based Thresholds of TransCelerate BioPharma for Risk-Based Monitoring."

The quality of data from clinical trials has received a great deal of attention in recent years. Of central importance is the need to protect the well-being of study participants and maintain the integrity of final analysis results. However, traditional approaches to assess data quality have come under increased scrutiny as providing little benefit for the substantial cost. Numerous regulatory guidance documents and industry position papers have described risk-based approaches to identify quality and safety issues. In particular, the position paper of TransCelerate BioPharma recommends defining risk thresholds to assess safety and quality risks based on past clinical experience. This exercise can be extremely time-consuming, and the resulting thresholds may only be relevant to a particular therapeutic area, patient or clinical site population. In addition, predefined thresholds cannot account for safety or quality issues where the underlying rate of observing a particular problem may change over the course of a clinical trial, and often do not consider varying patient exposure.


Journal Details

This article was published in the following journal.

Name: Therapeutic innovation & regulatory science
ISSN: 2168-4804
Pages: 2168479017738981


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