Recent Publications: 2009-Present
  • Alemayehu, D., Berger, M. (2016). Big Data: transforming drug development and health policy decision making. Health Services and Outcomes Research Methodology. 16(3): 92.102


  • Charles Knirsch, C., Alemayehu, D. Botgros, R. et al. (2016). Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team. Clinical Infectious Diseases 63(suppl 2):S29-S36 ยท


  • Donnelly, H., Alemayehu, D., Botgros, R., et al. (2016). Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team Clinical Infectious Diseases 63(suppl 2):S39-S45


  • Alemayehu D, Utt E, Knirsch C. (2015), Vaccines: A review of immune-based interventions to prevent and treat disease. Journal of Clinical Pharmacology, 55: S93.S102. doi: 10.1002/jcph.397.


  • Alemayehu D. Methodological Considerations in Cost-Effectiveness Analysis. Proceedings of the 2nd International Economics & Finance Conference. International Institute of Social and Economic Sciences. pp 39-48. June 3-6, 2014, Vienna, Austria. ISBN: 978-80-87927-01-4.


  • Alemayehu D, Cappelleri JC. .Patient-reported Outcomes in Personalized Medicine.. In: Carini C, Menon SM, Chang M (editors). Clinical and Statistical Considerations in Personalized Medicine. Boca Raton, Florida: Chapman & Hall/CRC Press. New York: Chapman & Hall/CRC Biostatistics Series . Taylor and Francis. 2014


  • Alemayehu D, Knirsch C, Levenstein M. Statistical Considerations for Clinical Trials in Rare Diseases. Journal of Rare Disorders, 2014. Vol. 2, Issue 1, Pages 18-22.


  • Alemayehu D, Cappelleri JC. Evaluating methodological assumptions in comparative effectiveness research: overcoming pitfalls. Journal of Comparative Effectiveness Research, 2014, Vol. 3, No. 1 , Pages 79-93


  • Alemayehu D, Anziano R, Levenstein M. Perspectives on Clinical Trial Data Transparency and Disclosure. Contemporary Clinical Trials. 2014. Vol 39:28-33.


  • Alemayehu D, Cappelleri JC. Revisiting issues, drawbacks and opportunities with observational studies in comparative effectiveness research. Journal of Evaluation in Clinical Practice. 2013; 19:579-583.


  • Alemayehu D, Alvir J, Levenstein M, Nickerson D (2013). A Data-Driven Approach to Quality Risk Management. Perspectives in Clinical Research. 4(4): 221-226.


  • Cappelleri JC, Zou KH, Bushmakin AG, Alvir JM, Alemayehu D, Symonds T. Patient-Reported Outcomes: Measurement, Implementation and Interpretation. New York: Chapman & Hall/CRC Biostatistics Series . Taylor and Francis. 2014, 320 Pages, ISBN: 9781439873670


  • Alemayehu D, Cappelleri, JC. (2012). Conceptual and Analytical Considerations for Use of Patient-Reported Outcomes in Personalized Medicine. American Health & Drug Benefits. 5:310-316


  • Alemayehu D, Zou KH (2012) Applications of ROC Analysis in Medical Research: Recent Developments and Future Directions. Academic Radiology, Vol 19 (12) 1457-1464


  • Alemayehu D, Alvir J, Chappell PB, Knirsch, CA. A quantitative approach to enhancing risk assessment and mitigation in drug development. Applied Clinical Trials. 2012; 21 (4) 33-35


  • Alemayehu A, Quinn J, Cook J, Kunkel M, Knirsch CA. A Paradigm Shift in Drug Development for Treatment of Rare Multidrug Resistant Gram-Negative Pathogens Clinical Infectious Diseases. 2012; doi: 10.1093/cid/cis503


  • Alemayehu D. Assessing exchangeability in indirect and mixed treatment comparisons. Comparative Effectiveness Research. 2011;1: 51 - 55


  • Alemayehu D. Perspectives on Pooled Data Analysis: the Case for an Integrated Approach. Journal of Data Science. 2011; 9(3): 399-426


  • Alemayehu D. Trends in Comparative Effectiveness Research. Biopharmaceutical Report. 2011; 18 (1): 15-21


  • Alemayehu D, Alvir J, Jones B, Willke R. Statistical Issues with the Analysis of Non-Randomized Studies in Comparative Effectiveness Research. J Manag Care Pharm. 2011;17(9-a):S22-S26.


  • Alemayehu D, Sanchez R, Cappelleri, JC. Considerations on the Use of Patient-Reported Outcomes in Comparative Effectiveness Research. J Manag Care Pharm. 2011;17(9-a):S27-S33.


  • Alemayehu D, Levenstein M. "Toward a Pragmatic Policy on Authorship," Statistics, Politics, and Policy. 201r12; Vol. 2: Iss. 1, Article 6. DOI: 10.2202/2151-7509.1034. Available at: http://www.bepress.com/spp/vol2/iss1/6


  • Alemayehu D, Mardekian, J. Infrastructure Requirement for Secondary Data Sources in Comparative Effectiveness Research. J Manag Care Pharm. 2011;17(9-a):S16-S21.


  • Guo J, Alemayehu D, Shao Y. Tests for Normality Based on Entropy Divergences. Statistics in Biopharmaceutical Research. 2010; 2(3):408-418.


  • Alemayehu D, Andrews EN, Glue P, Knirsch CA. Considerations for the design and conduct of a pharmacovigilance study involving mass drug >dministration in a resource-constrained setting. PLoS Negl Trop Dis. 2010; 4(1):e564 20126267.


  • Alemayehu D. Evaluation of Reporting Bias in Postmarketing Risk Assessment Based on Spontaneous Reporting Systems. Pharmaceutical Medicine. 2009; 3(4):195-200.


  • Alemayehu D. Current Issues with Covariate Adjustment in the Analysis of Data from Randomized Controlled Trials. Am J Ther. 2011 Mar-Apr;18(2):153-7.