What is a Clinical Trial Protocol?

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  • Written By: Alexis W.
  • Edited By: Heather Bailey
  • Last Modified Date: 28 May 2019
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A clinical trial protocol refers to the method used to conduct a trial of a new drug or therapy. A clinical trial in general refers to the testing of a new method of treating an illness or disease, designed to determine the effectiveness and potential side effects of the particular treatment. The protocol used to conduct the testing is called clinical trial protocol.

Clinical trials are a very important part of the development of medicine. When a new drug or therapy or type of treatment is created, it usually has to be first tested extensively on animals. Eventually, however, it must be tested on humans to determine if it can work effectively when used to treat people.

The process of testing the new drug treatment or the new therapy regimen is called a clinical trial. The trial is normally conducted under specific, controlled standards. In other words, the doctors and scientists testing the theory or drug must follow specific mandates and rules designed both to protect the patients and ensure accurate results in testing.

The clinical trial protocol refers to the specific method used in a given clinical trial. When a clinical trail protocol is set, it must be followed religiously by all physicians and staff involved. This protocol is to ensure uniformity and that the results of the test can be used to gain approval for the drug, if the results are positive.


There are several common protocols used in clinical trials. For example, one common clinical trial protocol is referred to as the blind test. This test occurs when one group of patients is given a new drug therapy and the other group of patients is given a placebo, or a sugar pill that does not contain the therapy. The test is referred to as a blind test because the doctors and those conducting the exam do not know which patient has received the placebo and which has received the therapy; this allows the doctors to objectively record observations and progress without being biased toward those patients who have received the drug therapy.

Double blind and triple blind tests are also types of clinical trial protocol. Under these tests, even more precautions are used to keep secret the identity of the patients treated with the drug being tested. These protocols are necessary because often the drug companies who developed the drugs are the ones funding the study and, as such, objectivity must be guaranteed to ensure that only truly effective drugs pass clinical trials.



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