What sponsors get wrong about renal & hepatic studies — according to the people running them
Renal and hepatic impairment studies look manageable on paper. Defined patient categories. Clear regulatory guidelines. Predictable endpoints.
The teams who run them daily know otherwise. Recruitment takes longer than any plan accounts for. Design assumptions that seemed obvious turn out to be wrong. Studies that should have been resolved early end up on the critical path to registration — with consequences that cannot be undone.
Dr Maria Lehretz, Medical Director at hVIVO’s specialist renal and hepatic unit in Kiel, reveals the six misconceptions that most consistently derail these programmes — and makes the case for what a more rigorous approach looks like.
In this article, you will learn
- Why key impaired patient populations are harder to recruit than most plans assume — and which impairment categories present the greatest operational challenge
- How to determine whether a standalone RI/HI study is actually required, or whether PBPK modelling or population PK may satisfy regulators
- The study design gaps — dose selection, PK variability, control group matching — that most commonly surface during protocol discussions
- What separates a specialist renal/hepatic unit from a standard early-phase site when data quality is on the line
- Why the timing of RI/HI studies within the development programme directly determines what happens at registration
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