Comparative oncology as a tool in drug development is growing in recognition, but requires a deeper examination of the value of the approach and examples of the unmet needs in drug development that this approach could satisfy. This review seeks to demonstrate, through published literature and selected examples of comparative clinical trials, the types of drug development questions that are best answered by the comparative oncology approach. We maintain that consideration of the answers to these questions can begin to frame the value of this approach, thereby allowing a reasonable assessment of actual or perceived risks or costs. We believe common perceived risks of the comparative approach relate to uncertainty of how regulatory bodies will prioritize or react to data generated from these unique studies conducted in diseased animals, and how these new data will affect ongoing human clinical trials. We contend that it is reasonable to consider these data as potentially informative and valuable to cancer drug development, but as supplementary to conventional preclinical studies and human clinical trials particularly as they relate to the identification of drug-associated adverse events.
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