In the first part of the 20th century hospitals were expanding and new biologic and vaccine industries were emerging. Chemists developed novel therapeutic compounds, and, according to Bothwell and Podolsky, "an unregulated subeconomy of fraudulent replicas of new agents flourished.
The major influenza outbreak of the early 20th century became a very significant problem for payers. The underwriters at Met Life needed a way to separate the therapeutic wheat from the chaff. So this major insurance payer began funding alternate-allocation trials at multiple major hospitals in northeastern U. In , James Burns Amberson and colleagues published a study in which a coin flip randomly determined which of two seemingly equally divided groups of patients would receive sanocrysin for the treatment of tuberculosis.
Bothwell and Podolsky write that the number of alternate-allocation studies, however, was itself dwarfed by the number of articles promoting therapies on the basis of other forms of evidence, from laboratory and physiological justifications to case reports. Our sentiment overruled our reason. When Doll qualified in medicine in , new treatments were almost always introduced on the grounds that in the hands of professor A or in the hands of a consultant at one of the leading teaching hospitals, the results in a small series of patients seldom more than 50 had been superior to those recorded by professor B or some other consultant or by the same investigator previously.
Under these conditions variability of outcome, chance, and the unconscious leave alone the conscious in the selection of patients brought about apparently important differences in the results obtained; consequently, there were many competing new treatments.
The alternative-allocation school began to be challenged over this obvious problem of selection bias. The British led the way and U. Blinding of patient selection began. Assessments by researchers could be biased. So then came the double-blind method. To be considered clinically effective and eligible for payment by insurers and the government, you have to establish that your device is safe and effective to a statistically significant level.
In , U. Sifferman retired in the fall of , Drs. Clinical trials conducted at BPVH are part of the development of new medications or new label claims for existing medications such as preventatives, health disorder treatments, pain relievers, anti-infectives, food, etc.
With your pet participating in a clinical trial, you and your pet are assisting in the development or improvement of treatments for other pets. At BPVH you can rest assured that your pet's safety is our first concern. Any questions or concerns you may have will be addressed prior to enrollment.
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