Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials
The revision is intended to further assist stakeholders in the transition from non-clinical to early clinical development and in identifying factors influencing risk for new investigational medicinal products (IMPs). The document includes considerations on quality aspects, non-clinical and clinical testing strategies, study design and on conduct of FIH/early CTs. Strategies for mitigating and managing risks are given, including principles on the calculation of the starting dose to be used in humans, the subsequent dose escalations, the criteria for maximum dose and the conduct of the trial inclusive of multiple parts.
