ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data

Posted 26 July 2017 | By Michael Mezher 

ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data

The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection.

ICH says the goal of the guideline, referred to as ICH E19, will be to provide "harmonized guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented."

According to ICH, targeted approaches to safety data collection could reduce the burden on patients and facilitate more global participation in clinical studies.

"Unnecessary data collection may be burdensome to patients, and serves as a disincentive to participation in clinical research," ICH says.

The concept paper also notes that there is no widely accepted guidance on the topic, making it a prime candidate for harmonization.

And, ICH says the guideline will be consistent with existing risk-based approaches and quality-by-design principles.

While the concept paper points to the US Food and Drug Administration's (FDA) recently finalized guidance on safety data collection late-stage pre-market and postapproval studies issued in February 2016, it does not say whether the FDA guidance would be used as a model for the harmonized ICH guideline.

ICH first announced it would begin work on the new guideline, referred to as ICH E19 at its assembly meeting in Osaka, Japan last November. In the minutes for that meeting released in February, ICH noted that the FDA would lead the informal working group on the concept paper and develop the business plan for completing the guideline.

According to the business plan released alongside the concept paper, ICH expects a draft version of the guideline to be developed by November 2018 and finalized by November 2019 and ultimately adopted by and sent out to its members in June 2020.


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