Results 21 to 30 of about 52,007 (260)

Non-Inferiority Trials in Surgical Oncology [PDF]

Annals of Surgical Oncology, 2007
The classical randomized controlled clinical trial is designed to prove superiority of an investigational therapy over an established therapy or placebo (here referred to as "superiority trial"). Although the randomized controlled superiority trial has its well-grounded role, clinical trials of non-inferiority are equally important in the advance of ...
Fueglistaler P, Adamina M, Guller U
openaire   +3 more sources

A note on the determination of non-inferiority margins with application in oncology clinical trials

Contemporary Clinical Trials Communications, 2019
The goal of a non-inferiority trial is to evaluate whether the effect of an experimental treatment is not inferior to that of the active control. Determination of an appropriate non-inferiority margin is critical to the demonstration of non-inferiority ...
Binbing Yu, Harry Yang, Antony Sabin
doaj   +1 more source

Equivalence and Non‐inferiority Trials of CAM [PDF]

Evidence-Based Complementary and Alternative Medicine, 2004
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
openaire   +2 more sources

Is there a danger of “biocreep” with non-inferiority trials? [PDF]

Trials, 2011
Mainz//2011; 56. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds), 6. Jahrestagung der Deutschen Gesellschaft für Epidemiologie (DGEpi)
Beryl, P, Vach, W
openaire   +1 more source

Evidence-based sizing of non-inferiority trials using decision models

BMC Medical Research Methodology, 2019
Background There are significant challenges to the successful conduct of non-inferiority trials because they require large numbers to demonstrate that an alternative intervention is “not too much worse” than the standard.
Iris Lansdorp-Vogelaar, Reshma Jagsi, Jinani Jayasekera, Natasha K. Stout, Sandra A. Mitchell, Eric J. Feuer   +5 more
doaj   +1 more source

Is this a non-inferiority trial? [PDF]

British Journal of Psychiatry, 2013
Crawford et al [1][1] have set out to investigate whether screening for suicidal ideation among people who attend primary care services and have signs of depression increases the short-term incidence of feeling that life is not worth living. It seems to me that this is a non-inferiority trial, i.e.
openaire   +3 more sources

The limitations of equivalence and non-inferiority trials [PDF]

Psychological Medicine, 2018
AbstractEquivalence and non-inferiority trials are becoming more and more popular. Typically, they compare the effects of a treatment of interest with the current gold-standard treatment as the comparator. However, for this approach, the definition of equivalence or non-inferiority margins (NIM) is crucial, and no clear rules for their definition exist.
Winfried Rief, Stefan G. Hofmann
openaire   +2 more sources

Efficacy and safety of lower dose tenofovir disoproxil fumarate and efavirenz versus standard dose in HIV-infected, antiretroviral-naive adults: a multicentre, randomized, noninferiority trial

Emerging Microbes and Infections, 2020
Reduced doses of antiretroviral (ARV) drugs may lower toxicity while preserving efficacy. We aimed to evaluate the efficacy of reduced doses of both tenofovir disoproxil fumarate (TDF) and efavirenz for the treatment of HIV-1 infection.
Jun Chen, Rong Chen, Yinzhong Shen, Hongxia Wei, Xicheng Wang, Renfang Zhang, Zhiliang Hu, Ronghui Xie, Qiong Huang, Jiangrong Wang, Li Liu, Tangkai Qi, Zhenyan Wang, Wei Song, Yang Tang, Jianjun Sun, Hongzhou Lu   +16 more
doaj   +1 more source

Perception and acquaintance of stroke specialists on non-inferiority trials: An international survey

Journal of Stroke and Cerebrovascular Diseases
Introduction: The adoption of non-inferiority trial designs for assessing new interventions in stroke treatment is on the rise. We designed a survey to assess stroke specialists' understanding and familiarity with non-inferiority trials and margins ...
Aristeidis H. Katsanos, MD, Vasileios-Arsenios Lioutas, MD, Laetitia Yperzeele, MD, Teresa Ullberg, MD, Linxin Li, MD, Emily R. Ramage, PhD, Ivan A. Koltsov, MD, PhD, Julia Shapranova, MSc, George Howard, DrPH, Philip M. Bath, FMedSci, Maria Khan, MD   +10 more
doaj   +1 more source

Sample Size Estimation for Non-Inferiority Trials: Frequentist Approach versus Decision Theory Approach.

PLoS ONE, 2015
BackgroundNon-inferiority trials are performed when the main therapeutic effect of the new therapy is expected to be not unacceptably worse than that of the standard therapy, and the new therapy is expected to have advantages over the standard therapy in
A C Bouman, A J ten Cate-Hoek, B L T Ramaekers, M A Joore   +3 more
doaj   +1 more source