References
- Lin, M., Lee, S., Zhen, B., Scott, J., Horne, A., Solomon, G., and Russek-Cohen, E. (in press), “CBER's Experience with Adaptive Design Clinical Trials,” Therapeutic Innovation and Regulatory Science. doi:10.1177/2168479015604181.
- Pritchett, Y., Jemiai, Y., Chang, Y., Bhan, I., Agarwal, R., Zoccali, C., Wanner, C., Lloyd-Jones, D., Cannata-Andía, J.B., Thompson, T., Appelbaum, E., Audhya, P., Andress, D., Solomon, S., Manning, W.J., and Thadhani, R. (2011), “The Use of Group Sequential, Information-Based Sample Size Re-estimation in the Design of the PRIMO Study of Chronic Kidney Disease,” Journal of Clinical Trials, 8, 165–174.
- U.S. Food & Drug Administration. (2010), “Draft Guidance for Industry—Adaptive Design Clinical Trials for Drugs and Biologics,” available at http://www.fda.gov/downloads/Drugs/…/Guidances/ucm201790.pdf