Non-Inferiority Trials in Surgical Oncology
نویسندگان
چکیده
منابع مشابه
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...
متن کاملBio-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 ...
متن کاملCurrent issues in non-inferiority trials.
Non-inferiority (NI) trials enable a direct comparison of the relative benefit-to-risk profiles of an experimental intervention and a standard-of-care regimen. When the standard has clinical efficacy of substantial magnitude that is precisely estimated ideally using data from multiple adequate and well-controlled trials, with such estimates being relevant to the setting of the NI trial, then th...
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 کاملNon-inferiority trials: methodological and regulatory challenges
Background: A non-inferiority (NI) trial is intended to show that the effect of a new treatment is not worse than the comparator. We conducted a review to identify how NI trials were conducted and reported, and whether the standard requirements from the guidelines were followed. Methodology and Principal Findings: From 300 randomly selected articles on NI trials registered in PubMed at 5 Februa...
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ژورنال
عنوان ژورنال: Annals of Surgical Oncology
سال: 2007
ISSN: 1068-9265,1534-4681
DOI: 10.1245/s10434-006-9295-2