On the use of historical control data for trend test in carcinogenicity studies.

Historical control data are often available in carcinogenicity studies and are included for testing dose effects in current studies. A new method is developed for incorporating the historical control information into a dose effect test. The method generalizes the test procedures proposed by Tarone (1982, Biometrics 38, 215-220) and Ibrahim and Ryan (1996, Biometrics 52, 1478-1485) by taking into account the variation resulting from parameter estimation based on historical data. Two examples are discussed for illustrating the proposed method.