Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

Author:

Gamble Carrol1,Krishan Ashma2,Stocken Deborah34,Lewis Steff5,Juszczak Edmund6,Doré Caroline7,Williamson Paula R.1,Altman Douglas G.8,Montgomery Alan9,Lim Pilar10,Berlin Jesse11,Senn Stephen12,Day Simon13,Barbachano Yolanda14,Loder Elizabeth15

Affiliation:

1. Biostatistics Department, University of Liverpool, Liverpool, England

2. Clinical Trials Research Centre, University of Liverpool, Liverpool, England

3. Newcastle University, Newcastle, England

4. Currently with Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, England

5. Edinburgh University, Edinburgh, Scotland

6. University of Oxford, Oxford, England

7. UCL Comprehensive Clinical Trials Unit, London, England

8. Centre for Statistics in Medicine, University of Oxford, Oxford, England

9. University of Nottingham, Nottingham, England

10. Janssen Research & Development LLC, Raritan, New Jersey

11. Johnson & Johnson, Titusville, New Jersey

12. Luxembourg Institute of Health, Strassen, Luxembourg

13. Clinical Trials Consulting & Training Limited, Buckingham, England

14. Medicines and Healthcare Products Regulatory Agency, London, England

15. BMJ, London, England

Publisher

American Medical Association (AMA)

Subject

General Medicine

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