Uncontrolled Spread: Why COVID-19 Crushed Us and How We Can Defeat the Next Pandemic

by Scott Gottlieb

The trial was blinded to the investigators and Pfizer. It’s standard practice in trials for patients to be randomly assigned to receive an experimental treatment or an alternative meant as an inert or predictable comparator (a placebo), to see if the novel agent is working, and for the investigators and the patients to be blind to who received what. Only the data safety monitoring board (DSMB) knew who was getting the vaccine and who was getting the placebo. A DSMB is an independent group of clinicians and scientists who monitor the safety of patients while a trial is ongoing. They also continuously evaluate how well an experimental drug or vaccine might be working. They can intervene to stop the trial early if they find that the product is especially effective and should be declared to work and be given to everyone, or if it’s judged to be ineffective and continued treatment with it is futile, or worse, it’s judged to be causing harm.32 The DSMB also reports the results when the trial reaches certain prespecified milestones.