Bayesian Design of Non-inferiority Clinical Trials Via the Bayes Factor

Bio-creep in non-inferiority clinical trials.

After a non-inferiority clinical trial, a new therapy may be accepted as effective, even if its treatment effect is slightly smaller than the current standard. It is therefore possible that, after a series of trials where the new therapy is slightly worse than the preceding drugs, an ineffective or harmful therapy might be incorrectly declared efficacious; this is known as 'bio-creep'. Several ...

Equivalence and non inferiority trials

Many effective drugs, biologics and devices exist. Because of this, it is often considered unethical to undertake placebo controlled clinical trials to evaluate new treatments. Rather, randomized active control noninferiority trials have become the norm. These trials, however, are accompanied by serious issues including selecting an active comparator, identifying previously run active comparato...

Non-Inferiority Clinical Trials to Establish Effectiveness Guidance for Industry

Non-inferiority versus equivalence clinical trials in assessing biological products.

Non-inferiority cancer clinical trials: scope and purposes underlying their design.

BACKGROUND Non-inferiority clinical trials (NIFCTs) aim to demonstrate that the experimental therapy has advantages over the standard of care, with acceptable loss of efficacy. We evaluated the purposes underlying the selection of a non-inferiority design in oncology and the size of their non-inferiority margins (NIFm's). PATIENTS AND METHODS All NIFCTs of cancer-directed therapies and suppor...