منابع مشابه
Design choices for small-scale phase II trials with non-inferiority (NI) intention
Background So far, NI trials are almost exclusively performed in phase III setting. However, the NI question might already be relevant in phase II setting in several scenarios, like: treatment optimization in diseases for which standard treatments already exist, or investigation of cytostatic agents, or rare diseases for which a phase III trial will not be feasible, or try to establish a reduce...
متن کاملPhase IV non-inferiority trials and additional claims of benefit
BACKGROUND Non-inferiority (NI) trials in drug research are used to demonstrate that a new treatment is not less effective than an active comparator. Since phase IV trials typically aim at informing a clinical decision, the value of a phase IV non-inferiority trial hinges also on its clinical relevance. In such trials, clinical relevance would refer to the added benefit claims of a specific dru...
متن کاملEquivalence 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...
متن کاملEquivalence and Non-inferiority Trials of CAM
For several reasons, the value of placebo-controlled trials has often been disputed (not only) in complementary/alternative medicine (CAM) (1). Many clinicians feel that giving placebos to suffering patients is unethical. In fact, the Declaration of Helsinki advocates placebo-controlled trials only for conditions for which no therapy of proven efficacy exists (2). Other frequently cited reasons...
متن کاملDesign issues of randomized phase II trials and a proposal for phase II screening trials.
Future progress in improving cancer therapy can be expedited by better prioritization of new treatments for phase III evaluation. Historically, phase II trials have been key components in the prioritization process. There has been a long-standing interest in using phase II trials with randomization against a standard-treatment control arm or an additional experimental arm to provide greater ass...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: Contemporary Clinical Trials Communications
سال: 2017
ISSN: 2451-8654
DOI: 10.1016/j.conctc.2017.04.008