Antibe Therapeutics is developing a badly-needed new class of anti-inflammatory and analgesic NSAIDs that seem to be much easier on the stomach. The FDA just approved the company's IND for otenaproxesul while the drug has already undergone Phase 2 trials in Canada and is gearing up for Phase 3. Not your typical path for drug development, but whatever works is just fine.
If a standard treatment exists for a medical condition, is it unethical to give patients who are enrolled in a clinical trial a placebo? Most would argue yes, but the ethics become unclear when the standard treatment has its own risks.
We've just gotten a whole bunch of good news – news we really needed – about finally getting the upper hand against COVID-19. Two vaccines, both more than 90% effective at protecting clinical trial participants against the disease, were announced just seven days apart. These numbers are well beyond expectations, but some critically important questions linger. Here they are. The answers will determine how successful the vaccines will be.
Given that more than 200,000 Americans have died (at least in part) due to COVID-19, there seems little to lose and much to gain by green-lighting human challenge trials in which volunteers are vaccinated and then deliberately infected with coronavirus. The U.S. should follow the UK's lead.
Are vaccines going to be adequately tested for safety and efficacy if Phase 3 clinical trials are not completed? Does convalescent plasma work to treat COVID? Is the COVID death toll inflated? We attempt to clarify these controversies.
FDA Commissioner Stephen Hahn indicated that his agency would be willing to grant emergency authorization to a coronavirus vaccine, even before it completes Phase 3 clinical trials. This is a reckless gamble and could cause an unmitigated public health disaster.
Vladimir Putin and the Kremlin's propaganda machine are working in overdrive.
Most drug and vaccine candidates fail. However, the success rate varies wildly depending on the therapeutic area. The probability that at least one coronavirus vaccine will win FDA approval is quite high, though that does not mean it will work well.
Virtually every day there's news about one or more clinical trials in progress or being planned. But most people don't fully understand what the different trials mean. ACSH advisor Dr. Katherine Seley-Radtke gives us a primer that clearly explains the entire process. Timely reading.
Dr. Derek Lowe, arguably the finest and most influential chemistry blogger in the universe, has put together an excellent summary of the complex and confusing clinical data of hydroxychloroquine, which he published recently in his blog in Science and Translational Medicine. We thank Derek and AAAS for allowing us to reprint this important article.
When does repeating research studies surpass confirming known findings, for the purposes of validating legitimacy, to entering the world of the redundant and wasteful? When does more become less?
A premature infant is born with a form of severe lung injury that carries a 20% chance of survival. Her physician decides to throw a medical “Hail Mary” and try an untested adult technique to bypass the injured lungs. The infant survives, and after a few more tries, the physician realizes that the survival rate may be as high as 80% with this new treatment. Does he know enough that the treatment should become standard practice, or is a randomized clinical trial required?