The Prevention and Treatment of Missing Data in Clinical Trials

Download Article

Authors : Prajna Panda Kumar


This review critically analyzes the article ‘The Prevention and Treatment of Missing Data in Clinical Trials in the New England Journal of Medicine (NEJM). The review will summarize the article by providing the purpose for the article, how research was conducted, the results and other pertinent information from the article. The review will also critique the article analyze the article’s accessibility and credibility based on its relevance to the subject matter. It will highlight some relevant progress in the topic under study that might have occurred since the article was published.

The article was well written, clear and relevant to the challenges facing the clinical research industry. Missing data points threaten the validity of many clinical trials. At the request of the Food and Drug Administration (FDA) and with its funding, the panel on the handling of missing data in clinical trials was created by the National Research Council's (NRC) Committee on National Statistics. This panel published a report with recommendations that was intended to be used by the FDA for guidance on handling missing data for the entire clinical trial community so that the latter can take measures to improve the conduct and analysis of clinical trials. The current article provides an overview of the findings and recommendations of the resultant report from the perspective of one member of the NRC panel.

Overall the paper succinctly summarizes issues related to missing data and the current state of challenges pertaining to the topic. It creates an understanding of the topic for the reader by discussing some of the main recommendations from the NRC panel’s report on this topic.


[1.], viewed 15October, 2013

[2.], viewed 19October, 2013

[3.] James, D., Dziura, Lori, A., Post, Qing, Zhao, Zhixuan, Fu, and Peter, Peduzzi. Strategies for Dealing with Missing Data in Clinical Trials: From Design to Analysis

[4.] Little, R. J., D’,Agostino, R., Cohen, M. L., Dickersin, K., Emerson, S. S., Farrar, J.T. et al. The prevention and treatment of missing data in clinical trials. N Engl J Med, 367(14):1355–1360. [PMC free article][PubMed]

[5.] Liu, G., Gould, A. L. (2002). Comparison of alternative strategies for analysis of longitudinal trials with dropouts. J Biopharm Stat, 12(2):207–226. [PubMed].

[6.] NAS. The Prevention and Treatment of Missing Data in Clinical Trials. The National Academies Press; 2010.

[7.] O’Neill, R. T., Temple, R (2012). The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it. ClinPharmacolTher, 91(3), 550–554. [PubMed].

[8.] Silvia, P. J., Kwapil, T. R., Eddington, K. M., & Brown, L. H. (2013). Missed beeps and missing data: Dispositional and situational predictors of non-response in experience sampling research. Social Science Computer Review. Doi:10.1177/0894439313479902.

[9.] Scharfstein, D. O., Hogan, J., Herman, A. (2012). On the prevention and analysis of missing data in randomized clinical trials: the state of the art. J Bone Joint Surg Am, 94(Suppl 1),80–84. [PMC free article][PubMed].

[10.]   Scharfstein, S., Neaton, J., Hogan, J., Little, R., Daniels, M., Roy, J. (2012). Minimal Standards in the Prevention and Handling of Missing Data in Observational and Experimental Patient Centered Outcomes Research [Internet]. Retrieved from: .

[11.]   Trials PoHMDiC. The Prevention and Treatment of Missing Data in Clinical Trials. National Academy Press; 2010.