This week, the journal Therapeutic Innovation & Regulatory Science published a peer-reviewed article, titled Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND, assessing the range of industry practices for safety monitoring and expedited reporting to U.S.-based investigators of IND research in late 2009.

In a small sample of survey respondents, most of whom represented relatively large pharmaceutical and biological companies, the authors found that these organizations maintain “robust structures, procedures, and staffing to manage large volumes of safety data and to meet specific requirements of expedited reporting to multiple regional and local regulatory authorities. However, their focus at the time of the survey was clearly on notification and assessment of individual case reports of SAEs. In contrast, respondents reported less emphasis on, and greater variation in, aggregate analysis, interpretation, and reporting of safety data. This pattern is consistent across multiple areas of safety data management, including procedures, clinical monitoring, use of external resources, and safety reporting.”

The authors concluded:

“These data suggest that investigators would likely benefit if industry sponsors decreased reporting of individual cases that are not readily interpretable and instead reported meaningful safety information from aggregate analyses.”

This publication resulted from CTTI’s SAE Reporting Project. For more information about this project, CLICK HERE.