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Happy 70th Birthday, Randomized Clinical Trial

The first randomized clinical trial in medicine, whose influence is still felt today, celebrates its 70th birthday this year.

It’s true that some will look back to much older clinical trials—Dr. James Lind's on a British ship in 1747, or even King Nebuchadnezzar’s around 550 B.C., as recorded in the Bible in the Book of Daniel, both of whom tested the effects of different diets on different groups.

But I found, while working on another article in this blog on first-in-human trials in the UK, that what is considered the first randomized clinical trial in medicine was the control trial of streptomycin to treat pulmonary tuberculosis, which was begun in 1946 by UK’s Medical Research Council, with Sir Austin Bradford Hill as statistician.

Hill is credited with instituting randomization in clinical trials.

In the 1946 study, as described in a 1948 MRC article, the determination of whether a patient would be treated by streptomycin and bed-rest or by bed-rest alone was made by reference to a statistical series based on random sampling numbers drawn up for each sex at each testing center. Neither group of patients knew that they were in a trial. Progress was assessed with monthly chest X-rays that were assessed by three specialists who didn’t know the identities of the allocation of patients to streptomycin with bed rest or bed rest alone.

That trial, which was begun in 1946, and its methods ultimately led to today’s almost universal use of randomized allocation in clinical trials.

Hill also and later helped demonstrate the connection between cigarette smoking and cancer.


Learn more about clinical trials at UNC. Visit jointheconquest.org

JOHN T. AQUINO
John has been with BNA since 2007. He writes for Bloomberg BNA's Life Sciences Law and Industry and Medical Research Law and Policy Report. His coverage includes court proceedings congressional hearings, conferences, regulatory affairs, and interviews. You can contact John at This email address is being protected from spambots. You need JavaScript enabled to view it..

Originally published at Bloomberg BNA Healthcare Blog

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