Welcome!

This website contains supplemental materials for the 2nd edition of

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

 

Datasets:

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

 

Programs:

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.