Oncology: Adaptive Interim Analysis

In a prostate cancer study involving 188 sites and 1,590 subjects on three Continents, Health Decisions performed an adaptive interim analysis to determine whether efficacy data was strong enough to enable an early NDA submission. Efficacy data was disappointing. However, the sponsor benefited strategically from earlier understanding of the test drug’s performance vs. the comparator. View the case study of a metastatic breast cancer trial.