More and more new drug applications are relying on historical controls, but this must be done carefully. This paper outlines the reasons why you might want to use historical controls versus concurrent controls, alternative analysis methods, and how to minimize the biases associated with historical controls..
Mercedeh Ghadessi, Rui Tang, Joey Zhou, Rong Liu, Chenkun Wang, Kiichiro Toyoizumi, Chaoqun Mei, Lixia Zhang, C. Q. Deng, Robert A. Beckman. A roadmap to using historical controls in clinical trials – by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG). Orphanet Journal of Rare Diseases, 15, 69 (2020). Available in html format or pdf format.