Results for: clinical trials
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,...
RFK Jr. resurrects an old antivax half-truth about “saline placebos” in randomized controlled trials of vaccines
Robert F. Kennedy, Jr. has resurrected the antivax claim that the childhood vaccine schedule has never been tested in randomized controlled trials (RCTs) with a saline placebo controls (and therefore the vaccine schedule is unsafe). This is an old and deceptive antivax half-truth that ignores both what constitutes a scientifically valid placebo and the ethical requirements for RCTs.
Peer review fail: Vaccine publishes antivax propaganda disguised as “reanalyses” of Pfizer and Moderna COVID-19 vaccine clinical trial data
In order portray COVID-19 vaccines as dangerous, Peter Doshi has now managed to get poorly designed and performed "reanalyses" of the clinical trial data used by the FDA to grant emergency use approval of the Pfizer and Moderna vaccines published in two reputable journals, The BMJ and Vaccine? What happened?
Homeopathy and Pre-Registered Trials
Preregistering clinical trials is a great idea, but we have to actually track registration.
How to design high quality acupuncture trials: The Good, The Bad, and The Ugly
Acupuncture advocates have published guidelines for "rigorous" acupuncture randomized controlled trials. While that sounds good on the surface, the devil is in the details, which reveal that the dedication to scientific rigor is perhaps not so strong.
Department of Justice prioritizes prosecution of clinical trial fraud, but systemic reform is needed
The U.S. Department of Justice recently announced it is aggressively pursuing clinical trial fraud, where unethical players create fictional trial participants, steal the drugs under study, and fabricate results. But systemic reform of the clinical drug trial system is needed to halt those who endanger public safety with bogus trials.
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...
Dexamethasone and Hydroxychloroquine: Why Randomized Controlled Trials Matter
What does the best evidence tell us about hydroxychloroquine and dexamethasone?
Would you pay $1 million to enroll in a phase 1 clinical trial of an “anti-aging” gene therapy?
Libella Gene Therapeutics, LLC made the news last week for announcing a "pay-to-play" trial of its telomerase-based anti-aging gene therapy. What was shocking about the announcement was not that it was a "pay-to-play" trial, given that such trials have become all too common, but rather the price of enrollment: $1 million. Worse, the trial is being conducted in Colombia; the therapy doesn't...
Whither the randomized controlled clinical trial?
With the rise of precision medicine and genomics, the conventional randomized clinical trial appears more and more outdated. Fortunately, clinical trials are evolving, but will it be enough to incorporate the numerous advances in "-omic" medicine in a rigorous scientific manner to benefit patients?