Factors influencing the interim interpretation of a breast cancer trial: danger of achieving the "expected" result.
Interim analyses of a metastatic breast cancer trial suggested a significant survival benefit for a five-drug combination chemotherapy compared to a single agent sequential treatment. Subsequent analyses failed to support this observation. Factors influencing the interim interpretation of this trial were investigated and found to include: delayed reporting of data in key cases, treatment effect limited to a patient subset, and problems related to achieving the "expected" result.
D000970:Antineoplastic Agents / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D009362:Neoplasm Metastasis; D012107:Research Design; D013997:Time Factors
D000970:Antineoplastic Agents