On July 8-9, 2015, the Association of American Cancer Institutes (AACI) will host their 7th Annual AACI Clinical Research Initiative Meeting in Chicago. The results of CTTI’s IND Safety Advancement Project survey and interviews will be featured in the session titled, How Do Cancer Centers Ensure Patient Safety when Conducting Clinical Trials? The goal of this CTTI project is to increase compliance with respect to assessment, communication, review, and management of expedited IND safety reports. We look forward to this opportunity to share our work with colleagues.

Are you interested in safety reporting in clinical trials? Click here to read CTTI’s recommendations that resulted from our original IND Safety Project.

CTTI’s Executive Committee recently approved the IND Safety Advancement Project. This project is a follow-up to CTTI’s IND Safety Project, which issued recommendations in late 2013. These recommendations are intended to improve clinical trials by helping sponsors to ensure recognition of important safety issues for study drugs and biologics as early as possible during development.

Both of these projects were initiated in response to the FDA’s final rule published on September 29, 2010. This rule established new reporting requirements for serious and unexpected adverse reactions occurring in clinical trials conducted under an investigational new drug application (IND) (CFR 21.312). Although this rule, which was intended to improve the overall quality of safety, was published nearly four years ago, anecdotal reports indicate that implementation problems remain, particularly in oncology clinical trials.

While the original IND Safety Project sought to better understand current practices among sponsors for assessing and communicating the safety of an IND, the advancement project focuses on clarifying motivations and challenges to full implementation of the IND safety reporting rule. The anticipated impact of this new project is an increase in compliance with respect to assessment, communication, review, and management of serious adverse events and serious unexpected safety adverse reports.

Please visit the CTTI website for regular project updates.

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.