This website contains supplemental materials for the 2nd edition of

Design and Analysis of Quality of Life Studies in Clinical Trials.



There are six clinical trials that are used as examples in the book. Four are derived from actual trials; two are simulated. All are modified to protect both the trial participants and the sponsors. I have obtained data use agreements for the four derived from actual trials for educational use only. I will ask you to make the same commitment and use the datasets solely for the purpose of learning the techniques presented in the book.


For each study, there is a PDF dictionary with variable names, descriptor and coding if applicable. The datasets ending in 3 contain the merged baseline and longitudinal data. The datasets are for SPSS (*3.sav), R (*3.csv), Stata (*3.dta) and SAS (*3.sas7bdat). There is an additional SAS format file (format.sas7bdat). For a few studies, there are two additional SAS datasets separating the baseline data (*1.sas7bdat) from the longitudinal data (*.2.sas7bdat).


Study 1: Adjuvant Breast Cancer Trial.

Study 2: Migraine Prevention Trial.

Study 3: Lung Cancer Trial.

Study 4: Renal-cell Carcinoma Trial

Study 5: Chemoradiation (CXRT) Trial

Study 6: Osteoarthritis Trial



The following sections contain selected programs that are used in the book along with some additional programs that were omitted due to space constraints.


Chapter 3: Repeated Measures Models Study 1 (SAS, SPSS and R)

Chapter 4: Growth Curve Mixed Effects Models Study 2 (SAS, SPSS and R) (Modified 9Sep10)

Chapter 4: Growth Curve Mixed Effects Models Study 4 (SAS, SPSS and R)

Chapter 4: Growth Curve Mixed Effects Models Study 6 (SAS only)


Chapter 5: Mediation Study 2 (SAS only)


Chapter 9: Multiple Imputation Study 3 (SAS, SPSS and R)


Chapter 10: Mixture Models Study 3 (SAS and R)

Chapter 11: Conditional Linear Model Study 3 (SAS, SPSS and R)

Chapter 11: Varying Coefficient Model Study 3 (SAS only)

Chapter 11: Joint Model Study 3 (SAS and R)

Chapter 11: Joint Model Study 6 (SAS only)


Chapter 13: Multiple Comparisons Study 1 (SAS only)


Chapter 15: Q-TWiST Study 1 (SAS only)


Chapter 16: Sample Size calculations for RM and GC studies (SAS only)


Appendix S: Bootstrap Macros (SAS)

Supplementary R functions


If readers are aware of software capabilities that I am not, I would be happy to add their programs to this Website.