Results for: clinical trials
It’s time for true transparency of clinical trials data
What makes a health professional science-based? We advocate for evaluations of treatments, and treatment decisions, based on the best research methods. We compile evidence based on fair trials that minimize the risks of bias. And, importantly, we consider this evidence in the context of the plausibility of the treatment. The fact is, it’s actually not that hard to get a positive result...
Why Do We Really Need Clinical Trials?
A point I make over and over again when talking about new or alternative therapies that are not supported by good clinical trial evidence is that lower-level evidence, such as theoretical justifications, anecdotes, and pre-clinical research like in vitro studies and animal model testing, can only be suggestive, never reliable proof of safety or efficacy. It is necessary to begin evaluating a...
The wrong way to “open up” clinical trials
Science-based medicine rests on twin pillars that are utterly essential to the development of treatments that are safe and efficacious. Both of these pillars depend on science, but in different ways. The first of these is, of course, the basic science that provides the hypotheses to test about the mechanisms behind the diseases and malfunctions that plague the human body. This basic...
Clinical equipoise versus scientific rigor in cancer clinical trials
A critical aspect of both evidence-based medicine (EBM) and science-based medicine (SBM) is the randomized clinical trial. Ideally, particularly for conditions with a large subjective component in symptomatology, the trial should be randomized, double-blind, and placebo-controlled. As Kimball Atwood pointed out just last week, in EBM, scientific prior probability tends to be discounted while in SBM it is not, particularly for therapies...
On the dangers of using valid placebo controls in clinical trials of acupuncture
I don’t recall if I’ve ever mentioned this before on this blog, but there was a time when I was less skeptical of acupuncture than I am now. It’s true. Don’t get me wrong, though. I never for a minute considered that the whole rigamarole about “unblocking” or “redirecting” the flow of that mystical life force known as qi had anything to...
Threats to science-based medicine: When clinical trials for new drugs are designed by the marketing division
When the marketing division designs clinical trials, scientific medicine loses.
On the ethics of clinical trials of homeopathy in Third World countries
I’m on the record multiple times as saying that I reject the entire concept and nomenclature of “alternative medicine” as being distinct from “conventional” medicine as a false dichotomy, when in reality there should be just “medicine.” Indeed, if there is one major theme to which this blog is dedicated it’s that medicine should be as much as possible science-based, a concept...
Dubious for-profit stem cell clinics: Co-opting ClinicalTrials.gov as a marketing tool
Over twenty years ago, cancer quack Stanislaw Burzynski pioneered the abuse of the clinical trial process as a marketing tool to sell his antineoplastons. Now, for-profit stem cell clinics are using ClinicalTrials.gov as a marketing tool for their unproven therapies by listing dubious and scientifically worthless trials in this government database. What can be done?
ORBITA: Another clinical trial demonstrating the need for sham controls in surgical trials
Last week, the results of ORBITA were published. This clinical trial tested coronary angioplasty and stenting versus optimal medical management in patients with single-vessel coronary artery disease. It was a resoundingly negative trial, meaning that adding stenting to drug management didn't result in detectable clinical improvement. What was distinctive about this trial is that it used a sham procedure (i.e., placebo) control,...
Dubious stem cell trials for autism and the darker side of quackademic medicine
Despite a lack of evidence, Duke University is all-in on stem cells for autism, thanks to a billionaire benefactor and a highly dodgy for-profit Panama stem cell clinic. How did this come to be and what will be the outcome? Whatever the answers to these questions, it is clear that arrangements like the one between Duke University and The Stem Cell Institute...