unethical conduct of underpowered clinical trials

Unethical Conduct of Underpowered Clinical Trials

I read with interest the article on the effect of antiseptics on the colonization rate of central venous catheters, published in the recent issue of your Journal.1 Although the topic is very important, the study suffers from many shortcomings, the most important of which is low study power. Assuming expected prevalence rates of 22% and 17% in the control and treatment groups (an effect size of ...

The continuing unethical conduct of underpowered clinical trials.

Despite long-standing critiques of the conduct of underpowered clinical trials, the practice not only remains widespread, but also has garnered increasing support. Patients and healthy volunteers continue to participate in research that may be of limited clinical value, and authors recently have offered 2 related arguments to support the validity and value of underpowered clinical trials: that ...

The prevalence of underpowered randomized clinical trials in rheumatology.

OBJECTIVE The conduct of underpowered randomized controlled trials (RCT) has recently been criticized in medical journals. We investigated the current prevalence of underpowered RCT in rheumatology. METHODS We searched to identify randomized, prospective RCT assessing clinical efficacy of treatments for adult rheumatic diseases published in English in 2001 and 2002. RCT were assessed as posit...

Clinical Trials Registry--India: redefining the conduct of clinical trials.

Unethical placebo assignment in clinical trials of thrombolysis.

Marcia Angell, Executive Editor of the New England Journal of Medicine, recently argued that "the most frequent types of unethical research occurring today involve obtaining informed consent as a legalism, without truly informing the subjects, and inappropriately using a placebo group in a clinical trial" (1). From Figure 1, showing the chronologic relation of the main placebo-controlled trials...

Unregistered Trials Are Unethical

Susanne McCabe I fi nd the arguments raised by the PLoS Medicine editors very useful [1] as I had not considered that a scientifi c community would tolerate barring access to registers of trials. It leaves huge gaps for exploitation by privileged groups. It is not only colleagues in research and allied professions who need access but the global community, including members of the public whereve...