Clinical trials continue to be the gold standard for evaluating new medical technologies.
New advancements in modern computation power have led to increasing interest in …

The use of Bayesian methods to support pharmaceutical product development has grown in
recent years. In clinical statistics, the drive to provide faster access for patients to medical …

The pharmaceutical industry and its global regulators have routinely used frequentist
statistical methods, such as null hypothesis significance testing and p values, for evaluation …

Although the frequentist paradigm has been the predominant approach to clinical trial
design since the 1940s, it has several notable limitations. Advancements in computational …

Since the early 2000s, there has been increasing interest within the pharmaceutical industry
in the application of Bayesian methods at various stages of the research, development …

Bayesian statistical methods are being used increasingly in clinical research because the
Bayesian approach is ideally suited to adapting to information that accrues during a trial …

Regulatory science comprises the tools, standards, and approaches that regulators use to
assess safety, efficacy, quality, and performance of drugs and medical devices. A major …

The cost for bringing new medicine from discovery to market has nearly doubled in the last
decade and has now reached $2.6 billion. There is an urgent need to make drug …

Abstract Objective and Background The clinical trials community has been hesitant to adopt
Bayesian statistical methods, which are often more flexible and efficient with more naturally …

Abstract Objective and Background We assessed current understandings in interpretation of
Bayesian and traditional statistical results within the clinical researcher (non-statistician) …