Letter to the editor: Vaccine trial safeguards important

Staff Writer
Topeka Capital-Journal

Dr. James Ransom is a former colleague of great persuasive power, but I must challenge several points in his opinion piece regarding COVID-19 vaccines. As has Dr. Ransom, I also have had extensive personal experience in clinical trials.

There is nothing at all “curious” about a trial of a new drug in which 50% of the study subjects receive a placebo. Such a 1:1 randomization is the gold standard and is the safest and most efficient trial design. A study with even a 2:1 randomization (2 out of 3 subjects receives vaccine), the study would require 12% more patients to give results of same size effect and same statistical power. Such trials take longer to complete, are more expensive, and expose more patients to the potential and largely unknown risks of a drug of unproven benefit.

It is disingenuous to suggest anything is being “slow walked” for any reason. Never in medical history has vaccine development been so rapid. “Warp speed” is quite apropos. It has been learned the hard way that cutting corners on good science can lead to unanticipated and harmful outcomes. Even suggesting that a placebo group may not be needed is reckless disregard for scientific principle.

I am personally quite hopeful and optimistic that one or more safe and effective COVID-19 vaccine will soon be available. Fortunately, there is a vast, robust, multinational infrastructure of scientists and institutions who have achieved the capability of being able to respond as quickly and effectively as it has to this public health crisis. For that we should be thankful.

Stanley J. Vogel, Topeka