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THE THOMAS FRANCIS, JR. MEDAL
IN GLOBAL PUBLIC HEALTH |
The Polio Field Trials
The field study was pure Francis. He designed the double-blind section of the study exactly to his tastes and required that the…observed-control section be conducted with meticulous attention to rules of his devising….The paramount requirement was that the evaluation be entirely independent of external influence. A subsidiary requirement was that no work or deed of the National Foundation mislead the scientific community on this score. Francis’ independence had to be conspicuous and authentic.
Myron E. Wegman, MD, MPH
Dean Emeritus (dec.), U-M School of Public Health
from “Thomas Francis, Jr.: An Appreciation”
Archives of Environmental Health 21 (September 1970),230
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In an age of house-sized computers, IBM punchcards, propeller planes, and rotary telephones, the field trial that Thomas Francis proposed to test the safety and effectiveness of Jonas Salk’s polio vaccine could have been seen as madness.
But only by undertaking a massive study—with 1.8 million subjects, thousands of volunteers, and hundreds of locations in three different countries— could the vaccine be swiftly and robustly evaluated. If it worked, they’d know, and know for sure.
Francis, a pioneer of influenza vaccine development, insisted on what is known as a “double-blind” experiment for the field trial. Neither the physicians administering the shots, nor the children and their parents, would know whether it was the real Salk Vaccine in the syringe, or a fake. The rate at which each group succumbed to further polio infections would be closely tracked, and as a further measure, evaluated against a third group of children who had no shots at all.
Francis’ polio trials were strictly mapped out. In addition to the double-blind protocol, he specified three requests:
- Equal or greater numbers of children than those who were to receive the vaccine should receive an injection of an inert solution
- Both the control group and the actual group would be monitored in the same way
- There was to be “noninterference on the [NFIP] Foundation’s part.”
The report on the culmination of the field trials issued on April 12—known from then on as the Francis Report—was, in the words of the New York Times, “a medical classic.”
And the trials themselves “set the standard for the future by establishing the need for a double-blind controlled assessment of vaccine efficacy,” writes U-M professor Dr. Arnold Monto in a 1999 article published in Epidemiological Reviews.
For more information on the field trials, please visit the University’s History of Medicine website.
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