Recent Publications: 2009-2023
Monographs/Books
Alemayehu D, Emir B, Gaffney M. “Interface between Statistics and Regulation.” New York: Chapman & Hall/CRC
Biostatistics Series. Taylor and Francis. 2020, 172 Pages, ISBN-10 : 036749048X, ISBN-13 : 978-0367490485
Alemayehu D, Cappelleri JC, Emir B, Zou KH. “Statistical Topics in Health Economics and Outcomes Research.” New
York: Chapman & Hall/CRC Biostatistics Series. Taylor and Francis. 2018, 191 Pages, ISBN: 9781439879
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
Papers/Book Chapters
Cabrera J, Emir B, Duan Y, Alemayehu D. “An enriched approach to combining high-dimensional genomic and
low-dimensional phenotypic data.” To appear in:Journal of Biopharmaceutical Statistics. 2024.
de la Pena V, Gzyl H, Mayoral S, Zou H, Alemayehu, D. “Prediction and estimation of random variables with
infinite mean or variance.” To appear in:Communications in Statistics -Theory and Methods, 2024.
Dang LE, Gruber S, Lee H, Dahabreh IJ, Stuart EA, Williamson BD, Wyss R, Díaz I, Ghosh D, Kıcıman
E, Alemayehu D, Hoffman KL, Vossen CY, Huml RA, Ravn H, Kvist K, Pratley R, Shih MC, Pennello G, Martin D, Waddy
SP, Barr CE, Akacha M, Buse JB, van der Laan M, Petersen M. “A causal roadmap for generating high-quality
real-world evidence.”J Clin Transl Sci. 2023 Sep 22;7(1):e212. doi: 10.1017/cts.2023.635. PMID: 37900353; PMCID:
PMC10603361.
Liu J, Lu C, Jiang Z, Alemayehu D, Nie L, Chu H. “Borrowing concurrent information from non-concurrent
control to enhance statistical efficiency in platform trials.” Annals of Translational Medicine. Curr.
Oncol. 2023, 30(4), 3964-3973
Wang Z, Murray TA, Xiao M, Lin L, Alemayehu D, Chu H. “Bayesian hierarchical models for multivariate
meta-Analysis of diagnostic tests.”Stat Med. 2023 Dec 10;42(28):5085-5099. doi: 10.1002/sim.9902. Epub 2023 Sep
19. PMID: 37724773.
Alemayehu D,Knirsch C. “Clinical Trials in Immunotherapeutic Vaccine Development.” In: Prasad K (ed.),
Vaccine Development: From Concept to Clinic. Drug Discovery Series No. 3. The Royal Society of Chemistry. 2023:
91-111.
Jin L, Pang G, Alemayehu D. (2021). “Multi-Armed Bandit Design for Phase I Dose-Finding Clinical Trials
with Multiple Toxicity Types.”Statistics in Biopharmaceutical Research.
https://doi.org/10.1080/19466315.2021.1962402
Pang G, Alemayehu D, de la Pena V, Klass M. (2021). “On the bias and variance of odds ratios, relative
risk and false discovery proportion.”Communications in Statistics. https://doi.org/10.1080/03610926.2020.1867744
Cislo P, Emir B, Cabrera J, Li B, Alemayehu D. (2021). “Finite mixture models, a flexible alternative to
standard modeling techniques for extrapolated mean survival times needed for cost-effectiveness analyses.”Value
in Health. https://doi.org/10.1016/j.jval.2021.05.012
Alemayehu D, Hemmings R,Natarajan K, Roychoudhury S.(2021). “Perspectives on Virtual (Remote) Clinical
Trials as the ‘New Normal’ to Accelerate Drug Development.” Clinical Pharmacology &
Therapeutics.https://doi.org/10.1002/cpt.2248
Cook J, Pressler ML, Damle B, Alemayehu D, Knirsch CA. “The Weight of Evidence From Electrophysiology,
Observational, and Cardiovascular End Point Studies Demonstrates the Safety of Azithromycin.”Clin Transl Sci.
2021 Jan;14(1):106-112. doi: 10.1111/cts.12867. Epub 2020 Sep 21. PMID: 32956575; PMCID: PMC7537091.
Alemayehu D, Chen Y, Markatou M. (2018). “A comparative study of subgroup identification methods for
differential treatment effect: Performance metrics and recommendations.”Statistical Methods in Medical Research,
27(12), 3658–3678. https://doi.org/10.1177/0962280217710570
Alemayehu D, Mathew T, Willke R. (2018). “Methodological issues in health economic analysis.”In: D.
Alemayehu, J.C. Cappelleri, B. Emir and K. Zou (editors).Statistical Topics in Health Economics and Outcomes
Research. Boca Raton: Chapman and Hall/CRC. 2018:85-122
Alemayehu D,Bushmakin AG, Cappelleri JC. (2018). “Analysis of aggregate data.”In:Statistical Topics in
Health Economics and Outcomes Research. In: D. Alemayehu, J.C. Cappelleri, B. Emir and K. Zou (editors).
Statistical Topics in Health Economics and Outcomes Research. Boca Raton: Chapman and Hall/CRC. 2018:123-150
Alemayehu D,Cappelleri JC, Emir B, Sollano J. (2018). “Health Economics and Outcomes Research in
Precision Medicine.” In: D. Alemayehu, J.C. Cappelleri, B. Emir and K. Zou (editors).Statistical Topics in
Health Economics and Outcomes Research. Boca Raton: Chapman and Hall/CRC. 2018:151-176
Alemayehu D, Berger M, Doban V, Mardekian J. “Observational Data Analysis.”In: D. Alemayehu, J.C.
Cappelleri, B. Emir and K. Zou (editors).Statistical Topics in Health Economics and Outcomes Research. Boca
Raton: Chapman and Hall/CRC. 2018:47-68
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
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 ·
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 J. 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.
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.