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Abstract:
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For oncology drug development, Phase II proof-of-concept studies play a key role in determining whether or not to advance to a confirmatory Phase III trial. With the increasing number of immunotherapies, efficient design strategies are crucial in moving successful drugs quickly to market. Our research examines drug development decision making under the framework of maximizing socioeconomic investment, characterized by benefit cost ratios. In general, benefit represents the likelihood that a drug is successful and cost is characterized by the risk adjusted total sample size of the Phase II and Phase III studies. Under this framework, multiple scenarios can be considered. For example, for a given drug and cancer indication, benefit cost ratios can yield insights into whether to use a randomized control trial or a single arm study. More complex scenarios, such as decision making under restricted resources or with multiple potential cancer indications, can also be examined. Overall, benefit cost ratio analysis is an attractive decision making tool that can balance both potential risk and potential reward.
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