CLINICAL RESEARCH CENTER

LITTLE ROCK ALLERGY & ASTHMA, P.A.

Advancing Health Through Clinical Research

Patient Information

What is a Clinical Trial?
(Also known as a research study)
A clinical trial is a research study used to determine whether new drugs are both effective and safe. A clinical trial, under the supervision of a physician and other research personnel is the safest and fastest way to find new treatments that are effective.

What is a Study Protocol?
Clinical trials are carefully conducted under a specific set of instructions called a protocol. A protocol provides guidelines for the investigator to follow regarding who can participate in a trial, what tests should be performed, and information about medications taken.

Are Patients Protected?
There are strict guidelines to protect people that participate in clinical trials. Every study done in the U.S. must be approved by an Institutional Review Board (IRB). An IRB is an independent committee that reviews a study to insure that it is ethical. It is the IRB’s job to protect patients in clinical trials.

Have These Drugs Been Given Before?
Studies are usually conducted in three phases:

• Phase I studies– Drugs are first used in humans
• Phase II studies– Investigation of the safety and appropriate dose of a drug
• Phase III studies– Investigation of the safety and effectiveness of a drug

Dr. Karl V Sitz, our Medical Director, conducts an informed consent discussion.

What is Informed Consent?
This is a process by which a patient voluntarily confirms his or her willingness to participate in a study. The informed consent document should inform the study participant of important study facts including:

• Why the research is being done
• What the research hopes to accomplish
• What will be done to the subject during the study and for how long
• What risks are involved for the subject
• What benefits the subject may gain from participating
• What other treatments are available
• Assurance that a patient has the right to withdraw from the study at any time

Who Sponsors Clinical Trials?
Trials are sponsored by government agencies, pharmaceutical companies, hospitals or organizations that develop medical devices or equipment.

What If You Have Questions?
If at any time before, during or after your study participation you have questions about the study, you can contact the study investigators or research coordinators. Phone numbers for emergencies are also provided to all patients who participate in clinical trials.

Who Can Participate in a Study?
All clinical trials have guidelines about who can participate based on factors such as age, type of disease and medical history. Factors that allow you to be in a study are called inclusion criteria. Factors that keep you from participating are called exclusion criteria. It is the job of the study investigator and study staff to determine if you meet study inclusion or exclusion criteria.

Potential Benefits of Participating in a Clinical Trial

• Taking an active role in your health care
• Gaining access to new treatments that are not available to the public
• Trial related medical care from the research center staff during study participation
• Helping yourself and others by contributing to medical research

PRINCIPAL INVESTIGATOR:
Karl V. Sitz, M.D.

SUB-INVESTIGATORS:
Gene L. France, M.D. · Jim M. Ingram, M.D. · Deanna N. Ruddell, M.D.
Blake Sheer, M.D. · Ellen Lu, M.D.
Kelsy J. Caplinger, M.D.

RESEARCH MANAGER:
Mindy DeMarco, RN, BSN, CCRP

RESEARCH COORDINATOR:
Michelle Gray, LPN, CCRP