The following blog pertains to the 2017 SOT Annual Meeting Scientific Session "Advances in Preclinical Safety Testing: Progress in Implementation of ICH Guidances."
As an early-career toxicologist, I have spent a lot of time in the last two years becoming intimately familiar with the many ICH guidance documents. Since my experience with these guidance documents has only been for the last two years, it is sometimes hard to realize that these documents have not always been in the form that they are today. Some of the ICH guideline documents have undergone several revisions to get to the guidelines in use today. It also is reassuring to know that, periodically, guideline documents are identified as needing to be updated due to many factors, including evolving science.
In this session, several ICH guidance documents were discussed about which there is a current Expert Working Group assembled and they are working to update the documents to address changes in the field. Among these, ICH S5 (R3), a reproductive toxicology guidance revision, and ICH S11, a proposed new guidance based on the development on pediatric medicines were both discussed.
For ICH S5 (R3), it was determined that an update for this guidance document was needed in order to align ICH S5 with some of the other guidance documents like ICH M3 (R2), ICH S6 (R1), and ICH S9. There were some ICH guidelines that recommended embryo fetal development assessments that were not in ICH S5 (R2). Additionally, in order to reduce animal use, there will likely be options for combining certain fertility and embryo fetal development studies and/or peri/postnatal development studies outlined in the new revision. Some of these combination studies have already been described, but a detailed study design has not been available. The Expert Working Group will work to put together a more detailed study design for when these studies are combined. They are currently reviewing the first version of this revision internally and hope to have a completed revision to this ICH guidance document in 2019.
For ICH S11, it was determined that a new guidance document should be drafted to guide the development of pediatric medications. This new guidance document will inform juvenile studies and study design as there are currently conflicting recommendations for these studies regionally. The basic issues that this guidance document hopes to address are:
- how previous data can be used to determine if additional data is needed before clinical trials;
- when additional juvenile studies are needed (and when they are not); and
- details on the study design of juvenile studies.
They also are looking address the concerns and considerations of a "pediatric first" or "pediatric only" drug, which is intended only for pediatric populations. This working group also is currently evaluating the first draft of this document and hope to have a completed ICH S11 in 2019.