Clinical Research FAQs

What is a clinical research study?

Researchers evaluate the effectiveness of new medications, treatments and devices through clinical research studies. Investigational drug studies may involve comparing the study drug effectiveness and safety with other marketed medications or placebo (inactive drug), evaluating a drug for a new use, or evaluating different dosages or combinations of medications.

How is a drug approved for testing? 

The Food and Drug Administration must authorize a drug company’s proposal to do research studies. Once the studies have been completed, the FDA must review the information for safety and efficacy to determine if the drug works.  This process may take many years.

Who can participate in a research study? 

Anyone can volunteer for participation in a clinical research study. Each study has individual eligibility requirements. These requirements are based on things such as age, gender, type and stage of health condition (such as diabetes or arthritis), treatment history, and history of other medical conditions. Medical insurance is not required for participation in a research study.

The FDA has very strict requirements on the inclusion and exclusion criteria for research studies.  This means that a patient has to meet the FDA criteria before being entered into the trial.  There are also risks in participating in studies with new drugs. Your physician should review these risks with you to make sure you are comfortable with the study. You can learn more about the clinical trial process by visiting the FDA's website.

What is an Informed Consent? 

This consent must be obtained before any research procedures are done. It is a process designed to give volunteers the information they need to decide about participating in a research study.  It allows the volunteer to ask questions and exchange information freely with the investigator.

What are the benefits and risks of participation?

Known benefits and risks of a study are discussed with participants during the consent process. Discussion of risks and benefits is an ongoing process between the study participant and the research staff throughout the study.

Study participants are provided with study-related laboratory and diagnostic tests, physical exams, health education, study supplies and study medication at no cost. Volunteers in clinical research contribute to the evaluation of effectiveness and safety of new medications, treatments and devices.

The study drug may or may not be as effective as other treatments. As with any medication, research participants may experience side effects, which are sometimes serious.

How are volunteers protected?

In the United States, the U.S. Food and Drug Administration (FDA) must authorize a drug company’s research proposal before a drug study begins. Years of laboratory research are required before an investigational drug is approved for research in people.

An Ethics or Institutional Review Board (ERB/IRB) must also independently review and approve the study before it begins. These review boards are comprised of healthcare professionals and non-healthcare members whose goal is to protect the safety and rights of study participants.

Participants in research studies are followed closely during studies through lab and other diagnostic testing, physical examinations, and evaluation of symptoms and general health.

Centralized study drug safety information is regularly sent out to research investigators to keep study teams up-to-date on current findings. Any significant information is communicated to study participants as indicated during the study period.

What are my responsibilities as a volunteer?

It is important to provide accurate information to the research team about your health and medications.  Volunteers should be proactive informing other health care providers about participation in a clinical trial. 

During the study, it is important to be an active participant, asking questions and sharing health information as needed with the research team, as well as following study guidelines.

How can I find out more?

Contact the Clinical Research Department of Via Christi Clinic at 316-689-9542 to find out more about enrolling studies at Via Christi Clinic.

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