OBJECTIVES: In the US marketplace, regulations have been introduced that incentivize manufacturers to invest in drugs for orphan conditions. An orphan designation can lead to manufacturer benefits such as extended exclusivity as well as faster market approval. The objective of this research was to compare clinical trial attributes used in pivotal studies for both orphan and non-orphan oncology drugs. METHODS:  We identified all new oncology approvals between August 2011 and September 2015. We excluded indication expansions. We then collected detailed data on pivotal clinical trials used to gain approval such as study design, number of trials at approval for each indication, comparator type, sample size, trial phase, and major efficacy endpoints. We stratified data based on orphan designation and compared the aforementioned variables. RESULTS: