Question: Please help me find the sample size. In 2009, the FDA Oncology Drug Advisory Committee (ODAC) recommended that the drug Avastin be approved for use

Please help me find the sample size.

In 2009, the FDA Oncology Drug Advisory Committee (ODAC) recommended that the drug Avastin be approved for use in glioblastoma, a form of brain cancer. Tumor shrinkage after taking a drug is called a response. Out of 85 patients in a study to investigate the effectiveness of Avastin, 24 exhibited a response. Historically, response probabilities for brain cancer drugs were approximately 0.05.

Suppose we wanted to estimate the proportion of patients given Avastin who experience tumor shrinkage with a 95% CI with a margin of error no larger than 6%, i.e., m= .03. What sample size is required?

I calculated: n = 1.92²(0.5)(1 - 0.5) / (0.03) ²= 1067.11 = 1068 subjects

Is this correct?

Thank you!

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