Sample size determinations when two binomial proportions are very small

Sample size determination for testing the hypothesis of equality of proportions with a specified type I and type I1 error probabilitiesis of ten based on normal approximation to the binomial distribution. When the proportionsinvolved are very small, the exact distribution of the test statistic may not follow the assumed distribution. Consequently, the sample size determined by the test statistic may not result in the sespecifiederror probabilities. In this paper the author proposes a square root formula and compares it with several existing sample size approximation methods. It is found that with small proportion (p≦.01) the squar eroot formula provides the closest approximation to the exact sample sizes which attain a specified type I and type II error probabilities. Thes quare root formula is simple inform and has the advantage that equal differencesare equally detectable.