68 citations · 90 across the 4 of their papers we have counts for
5 papers
Challenges and Opportunities in Statistical Analyses and Designs for Neuroscience Clinical Trials
Jia Jia, Man Jin, Bo Lu +10
Drug development is a complex, costly, and high-risk process, with neuroscience representing one of the most challenging therapeutic areas due to the complexity of neurodegenerativ…
Considerations for Master Protocols Using External Controls
Jie Chen, Xiaoyun, Li +7
There has been an increasing use of master protocols in oncology clinical trials because of its efficiency and flexibility to accelerate cancer drug development. Depending on the s…
Flexible Seamless 2-in-1 Design with Sample Size Adaptation
Runjia Li, Liwen Wu, Rachael Liu +1
2-in-1 design (Chen et al. 2018) is becoming popular in oncology drug development, with the flexibility of using different endpoints at different decision time. Based on the observ…
Incorporating Surrogate Information for Adaptive Subgroup Enrichment Design with Sample Size Re-estimation
Liwen Wu, Qing Li, Mengya Liu +1
Adaptive subgroup enrichment design is an efficient design framework that allows accelerated development for investigational treatments while also having flexibility in population…
Principal Stratum Strategy: Potential Role in Drug Development
Björn Bornkamp, Kaspar Rufibach, Jianchang Lin +6
A randomized trial allows estimation of the causal effect of an intervention compared to a control in the overall population and in subpopulations defined by baseline characteristi…