Adjusting for bias in the mean for primary and secondary outcomes when trials are in sequence

JC Rothwell, SA Julious, CL Cooper - Pharmaceutical Statistics, 2022 - Wiley Online Library
When designing a clinical trial, one key aspect of the design is the sample size calculation.
The sample size calculation tends to rely on a target or expected difference. The expected …

A unified Bayesian framework for bias adjustment in multiple comparisons from clinical trials

Y Du, J Li, S Raha, Y Qu - Statistics in Medicine, 2024 - Wiley Online Library
In clinical trials, multiple comparisons arising from various treatments/doses, subgroups, or
endpoints are common. Typically, trial teams focus on the comparison showing the largest …

Selection bias, investment decisions and treatment effect distributions

SJ Wiklund, CF Burman - Pharmaceutical Statistics, 2021 - Wiley Online Library
When making decisions regarding the investment and design for a Phase 3 programme in
the development of a new drug, the results from preceding Phase 2 trials are an important …

A unified approach for evaluating the prediction of treatment effect across different types of endpoints

Y Qu, SY Park, Q Wu, W Shen - Pharmaceutical Statistics, 2022 - Wiley Online Library
Phase 2 and 3 development failure is one of the key factors for high drug development cost.
Robust prediction of a candidate drug's efficacy and safety profile could potentially improve …