A planned International Council for Harmonization (ICH) guideline on model-informed drug development (MIDD) will help optimize clinical trial designs, according to ICH, which estimates development of the guideline will be complete in three to four years.

The FDA and other regulators have signaled increased interest in MIDD, an approach that involves creating biological and statistical models from preclinical and clinical data and using these models to develop trial designs. The FDA is currently running a pilot program to spur the development of these models and evaluate their application to trial designs.

Such models can help optimize time and resources in early-phase trials and inform later-phase trials, ICH said in its roadmap to MIDD guideline development.

The approach currently lacks common documentation standards, consistent expectations for model assessments and understanding of terminologies, making it harder to efficiently evaluate model-based submissions, including the quality of the data involved, according to the ICH discussion group charged with developing the guideline.

The discussion group also recommended ICH revise its guideline on Dose Response Studies (E4) to incorporate principles developed for the MIDD guideline.

ICH said it may consider developing additional guidance on MIDD beyond the general principles in approximately three years.

Development and adoption of a new ICH guideline is a five-step process — from initial discussions and draft to final acceptance by ICH member countries — that can take up to a decade to complete.

Read the MIDD roadmap here: https://bit.ly/3yi1HAS.