Some examples of recurrent problems that present themselves in Pre-IND meetings include [2]:
Clinical trial design elements in the study synopsis – e.g., unsupported or lacking rationale for starting dose, missing specific safety assessments or time points, missing data safety monitoring board review
Anything less than the minimal chemical, manufacturing, and controls (CMC) information. Refer to the Chemistry, Manufacturing, and Controls Information Summary section for recommendations
Anything less than the minimal toxicology and pharmacology studies to support the proof-of-concept (POC). Refer to the Clinical Data Summaries section for recommendations
A study design that does not comply with Good Clinical Practices (GCPs)
Limited data supporting dose range
Now that you know the most common causes for concern, you can proceed to your Pre-IND meeting planning with the necessary information.