Given one Simon's two-stage design \((r_1,n_1,r,n)\)
and a true response rate \(p\),
we have the number of Stage-1 positive responses \(X_1 \sim \textrm{Binom}(n_1, p)\)
and the number of Stage-2 positive responses \(X_2 \sim \textrm{Binom}(n-n_1, p)\).
Obviously \(X_1\) and \(X_2\) are independent.
The probability of early termination is
$$p_{\textrm{frail}} = \textrm{Pr}(X_1 \leq r_1)$$
The probability of failure to reject \(H_0\) is
$$\sum_{s_1 = r_1+1}^{n_1} \textrm{Pr}(X_1=s_1)\cdot\textrm{Pr}(X_2 \leq (r-s_1))$$
The probability of successfully rejecting \(H_0\) is
$$\sum_{s_1 = r_1+1}^{n_1} \textrm{Pr}(X_1=s_1)\cdot\textrm{Pr}(X_2 > (r-s_1))$$
The expected sample size is
$$\textrm{E}(n) = p_{\textrm{frail}} \cdot n_1 + (1 - p_{\textrm{frail}}) \cdot n$$
Parameters nomenclature of r1
, n1
, r
and n
follows that of
PASS and function ph2simon.