• Immunopharmacol Immunotoxicol · Jan 2009

    When an interim analysis of randomized trial changes the practice in oncology: The lesson of adjuvant trastuzumab and the HERA trial.

    • Costanza De Rossi, Antonella Brunello, Giuseppe Jirillo, and Antonio Jirillo.
    • Instituto Oncologic. Veneto IRCCS, Padua, Italy. jirillo@libero.it
    • Immunopharmacol Immunotoxicol. 2009 Jan 1; 31 (1): 1-4.

    AbstractAbout 30% of the randomized clinical trials are stopped early because of appearance of clear clinical benefit. Though interim analyses protect patients in case of significant imbalance between two treatment arms, conclusions drawn from truncated studies can be premature and should be viewed with caution. We report the lesson learnt from the Herceptin adjuvant (HERA) trial.

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