Aims Publications Software Investigators Led by: Jianwen Cai, PhD
In this project, we propose to develop new statistical methodology to address issues in the design and analysis of clinical trials. We will investigate both the analytical and the empirical behavior of the proposed methodologies. Related software will be developed. These high impact and innovative statistical methods will improve public health by enabling accurate and efficient estimation of sample size and power for studies with time-to-event and longitudinal endpoints, cluster randomized cancer prevention and therapeutic trials, and cancer drug development trials. The specific aims are:
Aim 1: Develop methods for design and sample size calculation for longitudinal and joint models for longitudinal and survival data.
Aim 2: Develop statistical methodology for the design and analysis of group randomized cancer prevention trials with survival and recurrent event outcomes.
Aim 3: Develop statistical methodology for cancer drug development through the following three sub-aims:
i: | Develop methods for the design and analysis of clinical trials of targeted therapy. |
ii: | Develop designs for phase II trials that are predictive of phase III trial success. |
iii: | Develop methods for the design and analysis of partially randomized clinical trials. |