Overview of the Clinical Research Process

 

The information provided will assist you in determining if participating in a clinical trial is right for you.

A “clinical trial” is a research study that is designed to answer specific research questions. The study may involve the testing of a new drug, a device, a new therapy, a diagnostic tool, or the use of an already approved drug in a different disease. This type of testing is called “investigational,” which means that it is not approved by the Food and Drug Administration (FDA). The FDA is a federal agency responsible for monitoring and overseeing clinical trials, reviewing the results of clinical trials, and ensuring that drugs, medical devices, and biologics (such as vaccines) are safe and effective.

The purpose of a clinical research study is to find better ways to prevent, screen, diagnose, or treat diseases, and to provide options for improving the quality of life for people who have serious medical conditions.

People who agree to take part in a research study are usually called “human subjects," "research subjects," "research participants," or "volunteers”.

A doctor or a healthcare provider who conducts a study is usually called a “principal investigator," "clinical investigator," or a "study doctor”.

The study doctor is responsible for conducting the research study according to an approved plan or protocol. The “protocol” is a plan that describes what type of people may participate in the study, the schedule of tests, procedures, medications, dosages, and the length of the study, as well as the outcomes to be measured. The protocol may also be called a “study protocol," "study plan," or "research protocol”.

The study doctor is responsible for conducting the research study according to the protocol and for protecting the research subject enrolled in the study by minimizing the risks and maximizing the benefits.

To ensure the protection of research participants, the study doctor is responsible for the conduct and monitoring of the research, the collection of study data, and the study treatments that you receive. The study doctor will have a research team or study staff that will assist with the research study and may include other doctors, nurses, study coordinators, and healthcare professionals.

Many research studies that involve the testing of a new drug, a device, a new therapy, a diagnostic tool, or the use of an already approved drug in a different disease are usually paid for, developed and supported by the company that developed the product. The company is called the “Sponsor”. Some companies also work with some government agencies such as the National Institutes of Health and the National Cancer Institute to conduct and fund clinical research studies.

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