References
- Galwey, N. W. (2016), “Supplementation of a Clinical Trial by Historical Control Data: Is the Prospect of Dynamic Borrowing an Illusion?,” Statistics in Medicine, 36, 899–916. DOI: 10.1002/sim.7180.
- Grayling, M. J., and Mander, A. P. (2016), “Do Single-Arm Trials Have a Role in Drug Development Plans Incorporating Randomised Trials?,” Pharmaceutical Statistics, 15, 143–151. DOI: 10.1002/pst.1726.
- ICH (2001), “E10 Choice of Control Group and Related Issues in Clinical Trials,” The ICH Harmonised Tripartite Guidelines E10, available at https://www.fda.gov/science-research/guidance-documents-including-information-sheets-and-notices/ich-guidance-documents.
- Makuch, R. W., and Simon, R. M. (1980), “Sample Size Considerations for Non-Randomized Comparative Studies,” Journal of Chronic Diseases, 33, 175–181. DOI: 10.1016/0021-9681(80)90017-X.
- Papageorgiou, S. N., Koretsi, V., and Jäger, A. (2017), “Bias From Historical Control Groups Used in Orthodontic Research: A Meta-Epidemiological Study,” European Journal of Orthodontics, 39, 98–105. DOI: 10.1093/ejo/cjw035.
- Pocock, S. J. (1976), “The Combination of Randomized and Historical Controls in Clinical Trials,” Journal of Chronic Diseases, 29, 175–188. DOI: 10.1016/0021-9681(76)90044-8.
- Sacks, H., Chalmers, T. C., and Smith, H., Jr. (1982), “Biases in Patient Selection May Irretrievably Weight the Outcome of HCTs in Favor of New Therapies,” The American Journal of Medicine, 72, 233–240.
- Schoenfeld, D. A., Finkelstein, D. M., Macklin, E., Zach, N., Ennist, D. L., Taylor, A. A., and Atassi, N. (2019), “Design and Analysis of a Clinical Trial Using Previous Trials as Historical Control,” Clinical Trials, 16, 531–538. DOI: 10.1177/1740774519858914.
- Simon, R., and Thall, P. F. (1990), “Incorporating Historical Control Data in Planning Phase II Clinical Trials,” Statistics in Medicine, 9, 215–228. DOI: 10.1002/sim.4780090304.
- Wathen, J. K., Thall, P. F., Cook, J. D., and Estey, E. H. (2008), “Accounting for Patient Heterogeneity in Phase II Clinical Trials,” Statistics in Medicine, 27, 2802–2815. DOI: 10.1002/sim.3109.
- Williams, B. A. (2009), “Perils of Evidence-Based Medicine,” Perspectives in Biology and Medicine, 53, 106–120.
- Zhang, S., Cao, J., and Ahn, C. (2010), “Calculating Sample Size in Trials Using Historical Controls,” Clinical Trials, 7, 343–353. DOI: 10.1177/1740774510373629.