The Clinical Research Process

A clinical research study is a study that seeks to answer a specific scientific or health question. The study may test an unproven drug, an investigational medical device, a diagnostic tool, a food or drink, or an existing therapy used in a new way. The study also may involve an existing product used in a way that was previously found to be safe and effective in order to learn more about the product’s safety. Or the study may involve only the collection of health information in order to study a health issue in the general population.

People who volunteer to participate in a study may be called human subjects, research participants, or another term that identifies their role as volunteers in a clinical research study.

The doctor or healthcare professional who conducts the clinical research study may be called a clinical investigator, principal investigator or study doctor.

It is important to remember that the role of a clinical investigator is very different from the role of a health care provider. Either one may be a medical doctor, or nurse, but your health care provider is responsible for making health care decisions for you based upon your medical condition. A clinical investigator is responsible for conducting a research study according to that study’s protocol.

In a research study, you are a participant, not a patient. This means that the clinical investigator must conduct the study in a way that minimizes risks to you and maximizes any benefits, but the requirements of the study might limit the treatment options the investigator can provide.

If you volunteer to participate in a research study, you also should maintain contact with your regular doctor and other specialists before, during, and after your participation in the study. You should have the best information available about your health care decisions.

The people who assist the clinical investigator are part of the research team or study staff and generally include other doctors, nurses, study coordinators, and other healthcare professionals.

Finally, studies involving a product are generally paid for and supported by the company that developed the product. This company is called a sponsor. Some government agencies, such as the National Institutes of Health, also act as sponsors in funding clinical research.