There has been a major revision of the ICH guidance regarding the use of women of child bearing potential in clinical trials.
“In all ICH regions, inclusion of women of childbearing potential in clinical trials may be acceptable without non-clinical reproductive/development toxicology studies in certain circumstances”
The current ICH M3 states:
In the EU, assessment of embryo-fetal development should be completed prior to Phase I trials in women of childbearing potential.
In the US women of childbearing potential may be included in early, carefully monitored studies without reproduction toxicity studies provided appropriate precautions are taken to minimise risk.
The revise M3 states:
in all ICH regions women of child bearing potential can be included in clinical trials without non-clinical development toxicity studies (e.g., embryo-fetal studies) in certain circumstances.
In all ICH regions, women of child bearing potential can be included in repeated-dose Phase 1 and 2 trials prior to the conduct of the female fertility study since an evaluation of the female reproductive organs is performed in the repeated dose toxicity studies.
Two forms of contraception are required, one barrier and one hormonal.
Please note that in the EU this is NOT default position, it only applied in certain cases and includes restriction on numbers and duration.
This is important for a regulatory strategy and clinical development strategy front as it can have a huge impact on trial designs, and more importantly recruitment rates in early development. it also reduces the early stage burden in the development of female specific therapies.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch
