Clinical Research FAQ

What are clinical research studies?

Clinical studies are research studies in which real people participate as volunteers.Clinical research studies are a means of developing new treatments and medications for diseases and conditions.There are strict rules for clinical trials, which are monitored by the National Institutes of Health and the U.S. Food and Drug Administration.

Why should I participate in a clinical research study?

The health of millions has been improved because of advances in science and technology, as well as the willingness of thousands of volunteers to take part in clinical research. The role of volunteer subjects as partners in clinical research is irreplaceable in the search for knowledge to improve the health of future generations.

What are Phase I, Phase II, Phase III and Phase IV studies?

Phase I
During Phase I trials, drug makers are trying to determine safety and side effects of a drug by testing it on a human subject for the first time. Phase I studies usually involve healthy volunteers, but may include patients that have terminal illnesses with no other therapeutic alternative. These studies typically involve 100 or fewer subjects. If the results of the Phase I study are positive, the study moves on to Phase II.

Clarian Arnett Health Clinical Research does not currently perform Phase I studies.

Phase II
Phase II studies involve a drug whose dose and side effects are well known. Many more volunteer subjects are tested, to define side effects, learn how it is used in the body, and learn how it helps the condition under study.

Phase III
Phase III studies compare the new drug against a commonly used drug. Some volunteer subjects will be given the new drug and some the commonly used drug. The trial is designed to find where the new drug fits in treating a particular condition.

Phase IV
Phase IV trials involve the safety surveillance and ongoing technical support of a drug that has been marketed to the public. Phase IV studies may be mandated by regulatory authorities or may be undertaken by the sponsoring company for competitive or other reasons. These trials are often designed to detect any rare or long-term adverse effects over a much larger patient population and timescale than was possible during the initial clinical trials.

What are the risks involved in participating in clinical research?

There are risks are involved in clinical research, as there are in routine medical care and activities of daily living. Most clinical studies pose risks of minor discomfort, lasting only a short time. Although, some volunteer subjects do experience complications that require medical attention. The specific risks associated with any research trial are described in detail in the informed consent, which you are required to sign before taking part in a research study. The major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh the risks involved in study participation. 

How are participants in clinical research protected?

Participant safety is of the utmost importance in a clinical trial. All new protocols produced must be approved by an institutional review board (IRB) before they can begin. The IRB, which consists of medical specialists, statisticians, nurses, social workers, and medical ethicists, is the advocate of the volunteer subject. The IRB will only approve protocols that address medically important questions in a scientific and responsible manner.Participation in any research study is completely voluntary and can be stopped at anytime.  For every study in which you intend to participate, you will receive a document called "Informed Consent" that explains the study in straightforward language. Additionally, a member of the research team will discuss the protocol with you, explain its details, and answer your questions. You will not be rushed into making a decision, and you will be asked to sign the document only after you understand the nature of the protocol and agree to the commitment. At any time after signing the informed consent, you are free to change your mind and decide not to participate further without consequence.