"A calculated risk": the Salk polio vaccine field trials of 1954

Statistics in the Service of Health

“…Within this group, the "clinicians" panel supported the original observed controls design, while the "statisticians" panel recommended a randomized placebo controls design (Meldrum, 1998). A third "health officers" panel was divided, with most members supporting the observed controls design, but a vocal minority (including those at the more respected health departments of Massachusetts, New York, Michigan, Ohio, Illinois, and California) arguing forcefully in favor of the placebo controls design (Meldrum, 1998). Consequently, with strong backing from Dr. Francis, members of the advisory group, and outside experts (including well-known statisticians, such as Jerome Cornfield, Felix Moore, and Paul Meier), a dual design was adopted: 127 test areas in 33 states used the observed control design (consenting second graders were vaccinated, no placebo was given, and all first and third graders were used as controls), while 84 test areas in 11 states used a blinded randomized design (consenting children in grades 1-3 received injections of either vaccine or placebo and were then compared).…”

“…An independent Center was set up for the trial's implementation and evaluation under the direction of virologist Dr. Thomas Francis, Jr., who then convened an external advisory group to review the trial design and implementation. Within this group, the "clinicians" panel supported the original observed controls design, while the "statisticians" panel recommended a randomized placebo controls design (Meldrum, 1998). A third "health officers" panel was divided, with most members supporting the observed controls design, but a vocal minority (including those at the more respected health departments of Massachusetts, New York, Michigan, Ohio, Illinois, and California) arguing forcefully in favor of the placebo controls design (Meldrum, 1998).…”

“…In 1952, John Salk developed the inactivated polio vaccine, and soon after, plans were put in motion for a huge field trial to test the vaccine among young schoolchildren (Blume & Geesink, 2000;Meldrum, 1998). The vaccine trial was sponsored by the National Foundation for Infantile Paralysis (NFIP, later renamed the March of Dimes) and its early design called for observed controls, i.e., injecting the vaccine to consenting children, and using unvaccinated children as controls.…”

R&D Models: Lessons from Vaccine History

“…The trial was initiated in 1954 in 1.8 million children at 211 test sites across the country, using a combination of placebo controls and "observed controls" (Meldrum 1998). O'Connor contacted six companies early in the trial to begin to produce the vaccine so that warehoused stock would be available for launching an immunization campaign as soon as the trial results were in (Baker 2000).…”

Dying for Science: Historical Perspectives on Research Participants' Deaths

“…Just two years later, for example, millions of American parents would sign forms requesting that their children take part in one of the largest and most publicized clinical trials ever undertaken, the Salk polio vaccine field trials of 1954 [20].…”