# Shein-Chung Chow, Mark Chang's Adaptive Design Methods in Clinical Trials (Biostatistics) PDF

By Shein-Chung Chow, Mark Chang

ISBN-10: 1584887761

ISBN-13: 9781584887768

ISBN-10: 158488777X

ISBN-13: 9781584887775

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Sample text

When δ < 0, the rejection of the null hypothesis indicates the non-inferiority of the test compound against the control. 25) σ˜ p follows a standard normal distribution for large sample. Thus, we reject the null hypothesis at the α level of significance if z > zα . 05 because when δ = 0, the test statistic should be the same as that for testing equality. Otherwise, we may claim superiority with a small δ that is close to zero for observing an easy statistical significance. In practice, the choice of δ plays an important role for the success of the clinical trial.

3 Statistical Inference To illustrate the impact on statistical inference regarding the target patient population after m protocol amendments, for simplicity, we will only focus on statistical inference on ε, C, and ∆ for the case where µ Actual is random and σ Actual is fixed. For the cases where (i) µ Actual is fixed and σ Actual is random, (ii) both µ Actual and σ Actual are random, (iii) µ Actual , σ Actual , and n j are all random, and (iv) µ Actual , σ Actual , n j , and m are all random, the idea described in this section can be similarly applied.

Chapter 7 provides several methods for adaptive sample size adjustment which are useful for multiple adaptive designs. 7 Adaptive seamless phase II/III design A phase II clinical trial is often a dose-response study, where the goal is to find the appropriate dose level for the phase III trials. It is desirable to combine phase II and III so that the data can be used more efficiently and duration of the drug development can be reduced. , 2006). , 2006). Bauser and Kieser (1999) provide a two-stage method for this purpose, where the investigators can terminate the trial entirely or drop a subset of regimens for lack of efficacy after the first stage.