The most important variable in FIH studies is dose. The choice of the starting dose, dose increment for subsequent doses, and the maximal dose to be investigated are common issues that need to be addressed in the study design. Selecting a starting dose and choosing the next dose levels are challenging. An overly conservative approach may lead to an endless study, whereas a too rapid escalation can lead to unacceptable toxicity. Although not always obvious, the maximal dose considered for testing should be stated in the protocol and the rationale for the upper range of doses selected should be clearly described. It is understandable that this maximal dose may never be reached.
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