On the use of historical control data in pre-clinical safety studies.

A number of methods to formally incorporate historical control information in pre-clinical safety evaluation studies have been proposed in literature. However, it remains unclear when one should use historical data. Focusing on the logistic-normal model, we investigate situations where historical studies may prove to be useful. Aspects of estimation (precision and bias) and testing (power) for treatment effect are investigated under different conditions such as the number of historical control studies, the degree of homogeneity amongst them, the level of treatment effect and different control rates. The possibility to use a selected subset of historical control studies is also explored.