As sourced from QZ, trials for new medications are notoriously tedious. Rare disease populations know more than most that the barriers to meeting the entry criteria of a trial can be high, time-consuming, and inflexible. The elongation of the process is meant to keep the trial groups safe and more accurately measure the effects of the drug. However, when it comes to COVID-19 or any pandemic, time is of the essence. The rapid spread and high death toll make the discovery urgent, but the lack of precedent and novelty of the disease mean there is no time for the years of research that typically go into clinical trial design. Doctors explain that as COVID-19 makes its way around the world, they must decide whether to use untested experimental drugs or let the virus run rampant. When many patients are suffering, ethical debates emerge about how to speed up making drugs accessible.
One popular place doctors turn to are drugs that are already approved for other diseases. Drugs that come from the medicine cabinet are already on hand and have proved safe enough for FDA approval, but may not be suitable for the given contagion. This is can be an ethical choice when there’s this type of suffering, but others find this reckless. As the executive director of the Multi-regional Clinical Trial Center at Harvard University, Rebecca Li explained:
“Clinical trials are there for a reason. Most drugs end up not working.”
Following Clinical Trial Protocol
The rigor of methodical clinical trial standards is vital for scientists to clearly understand what works and what doesn’t. There are standard protocols that help ensure results are valid, such as running trials with a placebo, giving patients drugs in strictly standardized ways, and maintaining that the administration of the drug is ‘double-blind,’ meaning neither the doctor nor patients knows whether they received the experimental drug or the placebo. These measures help deter bias when measuring the results. However, these precautions usually take prior planning, and when it comes to a pandemic, that’s not so feasible. Instead, it may be administered to the patient who seems to need it more. Or, as the WHO explained, they aren’t making trials double-blind because “it had to balance rigor with speed.”
The experts explain it gets even messier when it comes to testing for vaccines, which can be dangerous for the healthy people receiving the dose. They also often need a larger test group to make sure they’re administered safely, which doesn’t always work out. Stanley Perlman, Professor at the University of Iowa, says that when it came to the swine flu vaccine of 1976, they ended up with a large number of cases of Guillain-Barré syndrome, causing 25 deaths. This is the cost of missing stages and skipping rounds; sometimes it works, and sometimes participants pay the consequences.
“If you don’t do carefully controlled clinical studies, usually with a placebo, you go back years later and find out you’re wasting your time.” – Stanley Perlman