ICH announces development of new safety data collection guideline (ICH E19)

Sanyogita Rane

The International Council for Harmonization (ICH) announced development of a new guideline (Future ICH E19) on the collection of safety data during late-stage pre-market and post-approval clinical investigations of new drugs during the ICH meet held in Osaka, Japan (5-10 November 2016). This guideline aims to improve global health by encouraging studies on long-term effects, rare events and new indications of drugs while optimizing resources (e.g., no. of patients) required for such studies.

The objectives of this ICH meet were to extend its global reach to include new members and observers and to discuss 2 key changes, one around optimizing safety data collection (Future ICH E 19 guideline) and the other related to the proposed amendment of the Global Good Clinical Practice (GCP) guideline.

ICH plans to perform a broad review of its existing guidelines and a reflection paper is expected to be published on the ICH website in early 2017, which will include an outline of the long-term work planning, beginning with revision of the ICH E8 guideline in 2017.

Since Individual Case Safety Reports (ICSRs) are critical for drug safety surveillance by regulators around the world, the assembly agreed to an update on the implementation guide for the ICH ICSR guideline (ICH E2B(R3)) as well as the Q&A document. These documents will be published on the ICH website shortly.

In 1996, ICH came out with a breakthrough GCP guideline and framework for establishing harmonized standards for clinical trials, and then came the very important amendment (ICH E6(R2)) in 2015. The aim of this first amendment was to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and data integrity. ICH E19 will prove to be another stride toward harmonizing and optimizing the collection of safety data during late stage pre-market and post-approval clinical investigations of new drugs and new indications for approved drugs. It will be important for sponsors to harmonize clinical trial safety data processing, with respect to both systems (database) and processes. There would be an advantage in consolidating all safety data processing from clinical development programs with a single, dedicated safety solutions provider, even while clinical trials from the development program are managed by different Clinical Research Organizations (CROs). This strategy would make it easy for the sponsors to comply with the new guidelines.