Sequential patient recruitment monitoring in multi-center clinical trials

Biases in clinical trials with sequential monitoring

Objectives It is well known that a sequentially monitored clinical trial that stops early for benefit has a crude treatment difference that overestimates the true treatment effect. This has led to extended debate in the literature, with some researchers arguing that early stopping is an important source of bias in meta-analyses of clinical trials. We therefore investigated the implications of e...

Quantitative MR in multi-center clinical trials.

MRI has a wide variety of applications in the clinical trials process. MR has shown particular utility in the early phases of clinical development, when trial sponsors are interested in demonstrating proof of concept and must make decisions about allocation of resources to a particular compound based on the results from a small number of experimental subjects. This utility is largely due to the...

Therapeutic beneficence and patient recruitment in randomized controlled clinical trials.

Improved quality monitoring of multi-center acupuncture clinical trials in China

BACKGROUND In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM) convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for a...

Flexible sequential designs for multi-arm clinical trials.

Adaptive designs that are based on group-sequential approaches have the benefit of being efficient as stopping boundaries can be found that lead to good operating characteristics with test decisions based solely on sufficient statistics. The drawback of these so called 'pre-planned adaptive' designs is that unexpected design changes are not possible without impacting the error rates. 'Flexible ...