The design and conduct of clinical trials to limit missing data

Author:

Little R. J.1,Cohen M. L.2,Dickersin K.3,Emerson S. S.4,Farrar J. T.5,Neaton J. D.6,Shih W.7,Siegel J. P.8,Stern H.9

Affiliation:

1. Department of Biostatistics; University of Michigan; MI U.S.A.

2. Committee on National Statistics; National Academy of Sciences; Washington DC U.S.A.

3. Department of Epidemiology; Johns Hopkins University; MD U.S.A.

4. Department of Biostatistics; University of Washington; Seattle WA U.S.A.

5. Department of Biostatistics and Epidemiology; University of Pennsylvania School of Medicine; PA U.S.A.

6. School of Public Health; University of Minnesota; MN U.S.A.

7. Department of Biostatistics; University of Medicine and Dentistry of New Jersey School of Public Health; NJ U.S.A.

8. Johnson & Johnson; Radnor PA U.S.A.

9. Department of Statistics; University of California; Irvine CA U.S.A.

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference22 articles.

1. O'Neill RT Missing data in clinical trials intended to support efficacy and safety of medical products: the need for consensus 30th Annual Conference of the International Society for Clinical Biostatistics 2009 http://www.iscb2009.info/RSystem/Soubory/Prez\%20Tuesday/S18.3\%20O'Neill.pdf

2. International Conference on Harmonisation Efficacy Guideline E9 Dose-Response Information to Support Drug Registration 1994 1 36 http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

3. European Medicines Evaluation Agency Guideline on Missing Data in Confirmatory Clinical Trials Committee for Medical Products for Human Use 2010 1 12 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf

4. International Conference on Harmonisation Efficacy Guideline E4 Dose-Response Information to Support Drug Registration 1994 1 10 http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

5. International Conference on Harmonisation Efficacy Guidelines E10 Choice of Control Group and Related Issues in Clinical Trials 2010 1 29 http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html

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