Unless you are a researcher yourself, it’s very unlikely you’ve come in contact with a clinical trial protocol. So, what is a clinical trial protocol, anyway?
Broadly speaking, a protocol is a confidential document that describes the background and purpose of a clinical trial or study and precisely how it should be conducted. Basically, think of it as the “rules of engagement” for people working within medical research.
Protocols are important to ensure that all the required data is collected consistently by investigators at different locations. When the protocol is followed precisely, it makes it easy for sponsors and regulatory bodies like the FDA to analyze the data and make decisions about further development or approvals.
While the contents of protocols can vary greatly depending on the complexity of the clinical trial, all will at least contain the following components:
- Background: This describes any relevant information that led scientists to ask their research questions. This could include context on a particular disease, information on the population of people being studied, results from prior clinical studies, and much more.
- Objective: This is an explanation of the goals, aims, or purposes of the clinical trial. It includes the research questions being asked.
- Design: This is the plan for the type of study, and sometimes how the study groups will be organized. This section conveys, for example, if the study will be double-blind, which is when neither the participants nor the researchers know who is receiving a particular treatment. The design also includes the dosing schedule of any medications and the expected duration of the study.
- Methods: Closely related to the design of the protocol, the methods sections include all the details describing exactly how the study will be carried out. They might include more information about the participants, the criteria for inclusion and exclusion, and all procedures and assessments.
According to the National Institutes of Health, the goal of clinical trials are to determine if a new test or treatment works and is safe. Accordingly, the protocol is the document that outlines all aspects of the research and ensures participant safety.
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