The prevention and treatment of missing data in clinical trials: An FDA perspective on the importance of dealing with it

Clinical Pharmacology and Therapeutics

Volumn 91, Issue 3, 2012, Pages 550-554

  O'Neill, R T ^a   Temple, R ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DATA ANALYSIS; FOOD AND DRUG ADMINISTRATION; HUMAN; METHODOLOGY; PRACTICE GUIDELINE; PRIORITY JOURNAL; STUDY DESIGN;

CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS DATA MONITORING COMMITTEES; DATA INTERPRETATION, STATISTICAL; DRUG APPROVAL; HUMANS; INFORMATION STORAGE AND RETRIEVAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84857231864     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2011.340     Document Type: Article

References (7)

1. The Panel on Handling Missing Data in Clinical Trials; National Research Council. The Prevention and Treatment of Missing Data in Clinical Trials. National Academies Press, 2010 〈http://www.nap.edu/catalog.php?record-id= 12955#orgs
2. US Food and Drug Administration. Mission 〈http://www.fda.gov/ aboutfda/whatwedo/default.htm〉. Accessed 17 November 2011.
3. A mery, W. & Dony, J. A clinical trial design avoiding undue placebo treatment. J. Clin. Pharmacol. 15, 674-679 (1975).
4. Molnar, F.J., Man-Son-Hing, M., Hutton, B. & Fergusson, D.A. Have lastobservation-carried-forward analyses caused us to favour more toxic dementia therapies over less toxic alternatives? A systematic review. Open Med. 3, e31-e50 (2009).
5. Moher, D., Schulz, K.F. & Altman, D.; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 285, 1987-1991 (2001). (Pubitemid 32366951)
6. A ltman, D.G. Missing outcomes in randomized trials: addressing the dilemma. 〈http://www.openmedicine.ca/article/view/323/232〉. Accessed 17 November 2011.
7. Fleming, T.R. Addressing missing data in clinical trials. Ann. Intern. Med. 154, 113-117 (2011).