Happy Tuesday Friends!
A few months ago, I discussed how vaccines work in this blog, and I’m sure you’ve all heard about Operation Warp Speed (OWS) by now. If you haven’t, it’s a really nice example of a public-private partnership, where a number of government agencies and pharmaceutical companies are working together to test, manufacture and distribute COVID-19 vaccines. There are eight companies funded by OWS, including Janssen (Johnson and Johnson), AstraZeneca–University of Oxford, Pfizer-BioNTech, Moderna, and Novavax – all with vaccines candidates in clinical trials, and being manufactured at industrial scale right now. The project is moving right along, but as of October 7th, CNN reported that the US Food and Drug Administration wants to see at least 2 months of follow-up data after the volunteers get their second vaccine doses of these potential coronavirus vaccines. So, this means an approved vaccine is still several months away, but good clinical trial design (and safety data) protects us all.
So, what are the essential parts of a clinical trial?
Most clinical trials are designed as randomized, double-blind, and placebo-controlled trials:
Randomized: Each study subject is randomly assigned to receive either the study treatment or a placebo (fake or inactive treatment).
Double Blind: The subjects and the researchers involved in the study do not know which study treatment each participant receives. Many trials are designed this way to prevent researchers from treating the two study groups differently.
Placebo-controlled: The use of a placebo allows the researchers to hopefully isolate the effect of the study treatment from the placebo effect (when a benefit is seen due to the patient’s belief in the treatment)
Another essential component of a trial is the safety monitoring and follow-up. After every dose of treatment, trail participants are carefully monitored for even the smallest side-effects, as well as for efficacy (effect of the treatment.
And of course – the most important part of each clinical trial is the participants generous enough to enroll in the study.
If you are interested in learning more about potential trials, or volunteering for these trials, there is a website where people in the United States may join a registry to take part in clinical trials for vaccines and monoclonal antibody therapies: https://www.coronaviruspreventionnetwork.org/