Table of Contents

1 Randomized clinical trials with noncompliance: issues, definitions and problems of commonly used analyses.

1.1 Randomized encouragement design (RED).

1.2 Randomized consent designs.

1.3 Treatment efficacy versus programmatic effectiveness.

1.4 Definitions of commonly used terms and assumptions.

1.5 Mmost commonly used analyses for a RCT with noncompliance.

Exercises.

2 Randomized clinical trials with noncompliance under parallel groups design.

2.1 Testing superiority.

2.2 Testing noninferiority.

2.3 Testing equivalence.

2.4 Interval estimation.

2.5 Sample size determination.

2.6 Risk model-based approach.

Exercises.

Appendix.

3 Randomized clinical trials with noncompliance in stratified sampling.

3.1 Testing superiority.

3.2 Testing noninferiority.

3.3 Testing equivalence .

3.4 Interval estimation.

3.5 Test homogeneity of index in large strata.

Exercises.

Appendix.

4 Randomized clinical trials with noncompliance under cluster sampling.

4.1 Testing superiority.

4.2 Testing noninferiority.

4.3 Testing equivalence.

4.4 Interval estimation.

4.5 Sample size determination.

4.6 An alternative randomization-based approach.

Exercises.

Appendix.

5 Randomized clinical trials with both noncompliance and subsequent missing outcomes.

5.1 Testing superiority.

5.2 Testing noninferiority.

5.3 Testing equivalence.

5.4 Interval estimation.

5.5 Sample size determination.

5.6 An alternative missing at random (MAR) model.

Exercises.

Appendix.

6 Randomized clinical trials with noncompliance in repeated binary measurements.

6.1 Testing superiority.

6.2 Testing noninferiority.

6.3 Testing equivalence.

6.4 Interval estimation.

6.5 Sample size determination.

Exercises.

References.

Index.