Technical Reports : Longitudinal Endpoints

 
 

Group sequential clinical trials for longitudinal data with analyses using summary statistics.

  1. Summary: Group sequential analysis of longitudinal data in clinical trials, including software implementation.

  2. Ref: Kittelson JM, Sharples KJ, Emerson SS, Statistics in Medicine 24: pages (2005).



Estimates of information growth in longitudinal clinical trials.

  1. Summary: An investigation of nonmonotonic information growth in the analysis of longitudinal outcomes in RCT.

  2. Ref: Shoben AB, Emerson SS.



Information growth in longitudinal clinical trials

  1. Summary: AB Shoben Dissertation: An investigation of the application of group sequential methods in longitudinal clinical trials, with a particular focus on information growth.

  2. Ref: Shoben AB, University of Washington Department of Biostatistics (2010)



Analysis of longitudinal laboratory data in the presence of common selection mechanisms: A view toward greater emphasis on pre-marketing pharmaceutical safety.

  1. Summary: A discussion of approaches for effectively utilizing longitudinal laboratory data from early phase clinical trials to better understand the safety profile of new experimental therapies.

  2. Ref: Schildcrout JS, Jenkins CA, Ostroff JH, Gillen DL, Harrell FE, Trost DC, Statistics in Medicine 30: 2248-2266 (2008).


 


Technical Report Topics:


  1. •Probability models

  2. •General RCT methods

  3. •Noninferiority trials

  4. •Stopping rules

  5. •Adaptive methods

  6. •Implementation

  7. •Frequentist inference

  8. •Bayesian methods

  9. •Survival outcomes

  10. •Longitudinal outcomes

  11. •Medical diagnosis

  12. •Missing data

  13. •Software