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Practical and Statistical Considerations in Designing an Early Phase II Osteoarthritis Clinical Trial: A Case Study

After the withdrawal of Rofecoxib® in late 2004, the drug development environment for any new anti-inflammatory agents became more and more challenging. For every new compound developed to treat osteoarthritis (OA), both drug safety and drug efficacy are followed very closely. In this article, a true case study is presented to demonstrate how these considerations can be incorporated in an early Phase II clinical trial design. Simulations are performed to assess the power of this study, and to compare different methods in estimating minimum effective dose (MinED).