Publications
2017
Progress in the Fight Against Multidrug-Resistant Bacteria 2005-2016: Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance.
Rex, J. H., Talbot, G. H., Goldberger, M. J., Eisenstein, B. I., Echols, R. M., Tomayko, J. F., . . . Dane, A. (2017). Progress in the Fight Against Multidrug-Resistant Bacteria 2005-2016: Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance.. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 65(1), 141-146. doi:10.1093/cid/cix246
Factors for defining the robustness of the PK/PD package…..and how this affects the size of the clinical development program
Dane, A. (2017). Factors for defining the robustness of the PK/PD package…..and how this affects the size of the clinical development program. Washington DC.
Statistical and design approaches to allow more feasible antibiotic drug development
Dane, A. (2017). Statistical and design approaches to allow more feasible antibiotic drug development. London.
2016
Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.
McDonnell, A., Rex, J. H., Goossens, H., Bonten, M., Fowler, V. G., & Dane, A. (2016). Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 63 Suppl 2, S57-S59. doi:10.1093/cid/ciw244
Subgroup Analysis Approaches to Inform Regulatory Labelling. Outputs from the PSI Working Group on Subgroup Analysis.
Dane, A. (2016). Subgroup Analysis Approaches to Inform Regulatory Labelling. Outputs from the PSI Working Group on Subgroup Analysis.. Berlin.
The application of platform trials to antibiotic development
Dane, A. (2016). The application of platform trials to antibiotic development. Berlin.
2015
The use of limited data to achieve regulatory drug approval: Options for Antibiotic Drug Development.
Dane, A. (2015). The use of limited data to achieve regulatory drug approval: Options for Antibiotic Drug Development.. London.
2014
Statistical Considerations for a Tiered Approach to antibiotic drug development
Dane, A. (2014). Statistical Considerations for a Tiered Approach to antibiotic drug development. Washington DC.
Tackling emerging antibiotic resistance: Statistical challenges and options
Dane, A., & Wilson, D. (2014). Tackling emerging antibiotic resistance: Statistical challenges and options. Poster session presented at the meeting of BioInfect 2014. Alderley Park, Macclesfield.
Confidence intervals for the difference between independent binomial proportions: comparison using a graphical approach and moving averages.
Laud, P. J., & Dane, A. (2014). Confidence intervals for the difference between independent binomial proportions: comparison using a graphical approach and moving averages.. Pharmaceutical statistics, 13(5), 294-308. doi:10.1002/pst.1631
Statistical considerations associated with a comprehensive regulatory framework to address the unmet need for new antibacterial therapies.
Dane, A., & Wetherington, J. D. (2014). Statistical considerations associated with a comprehensive regulatory framework to address the unmet need for new antibacterial therapies.. Pharmaceutical statistics, 13(4), 222-228. doi:10.1002/pst.1625
2013
Statistical Input for Due Diligence - The do’s and don’ts
Dane, A. (2013). Statistical Input for Due Diligence - The do’s and don’ts. Glasgow.
A comprehensive regulatory framework to address the unmet need for new antibacterial treatments.
Rex, J. H., Eisenstein, B. I., Alder, J., Goldberger, M., Meyer, R., Dane, A., . . . Jackson, J. (2013). A comprehensive regulatory framework to address the unmet need for new antibacterial treatments.. The Lancet. Infectious diseases, 13(3), 269-275. doi:10.1016/s1473-3099(12)70293-1
2011
Active controlled studies in antibiotic drug development.
Dane, A. (2011). Active controlled studies in antibiotic drug development.. Pharmaceutical statistics, 10(5), 454-460. doi:10.1002/pst.518
Use of Pre-clinical Data for Clinical Decision Making in Antibiotic Drug Development
Dane, A. (2011). Use of Pre-clinical Data for Clinical Decision Making in Antibiotic Drug Development. Gloucestershire.
2009
Models for the analysis of C-reactive protein in statin trials.
Southworth, H., & Dane, A. (2009). Models for the analysis of C-reactive protein in statin trials.. Pharmaceutical statistics, 8(2), 87-97. doi:10.1002/pst.335
2006
Clinical Development & Registration issues for Anti-Infective products
Dane, A. (2006). Clinical Development & Registration issues for Anti-Infective products. London.
Design Considerations for Factorial Designs in Clinical Trials
Dane, A. (2006). Design Considerations for Factorial Designs in Clinical Trials. Bristol.