Atlanta Behavioral Research

FREQUENTLY ASKED QUESTIONS

What is a clincal trial?

Clinical trial is a scientific study that is carefully designed to test new treatment or medicinal product in human subjects under strict federal guidelines and supervision.

Why are clinical trials necessary?

Clnical trials are used to test for safety, efficacy and tolerability of new drugs or medicinal products or devices. New medications are tested through vigorous testing first in animals and then through human subjects from phase I to Phase III studies before approved for general public. 

Who approves new drugs? 

Food and Drug Administration (FDA) approves new drugs and new indications for already approved drugs. FDA regulates administration of clinical trials. All clinical trials are required to register and post on government website, clinicaltrials.gov. FDA is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. 

The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed^[4] and veterinary products. 

What are the different phases of clinical research?

Phase I trials are conducted in small group of people to determine the safety and tolerability of experimental drugs. Phase II trials are conducted in larger group of people to evaluate the effectiveness and safety. Phase III trials are conducted in much larger scale and compare new drugs with standard therapy to confirm the efficasy and monitor for side efffects. Phase III trials are usually followed by FDA approval of new drugs if successful. Phase IV trials are conducted after a drug is approved by FDA to track the safety, risks, benefits and optimal use. 

How can I find a studies that are conducted at Atlanta Behavioral Research?

You can search for a trial on our website: www.abrtrials.com or call us at (770) 458-0447. You can also find any study at federal website, www.clinicaltrials.gov . You can contact the study staff directly if you are interested in participating in any ongoing clinical trials. Out research site is located in our outpatient practice location, GA Psychiatric Services.

What can I expect if I participate in a clinical trial?

You will meet the research staff and you will get detailed information about potential risks and benefits of participating in a clinical study. You will sign informed consent forms if you agree to participate after hearing full disclosure about potential risks and benefits. You are considered enrolled in the trial once you sign informed consent documents. 

Each study has very specific protocol about how study is conducted. Research sibjects are generally enrolled randomly to either standard treatment or placebo or drug being tested. Most studies are double blinded which means both reasearch subject and investigator are blinded about assignment to either test drug or placebo. Sometimes there are open label studies in which both research subject and investigator know whether assigned to test drug or placebo. 

Each study varies about study procedures, lab tests, duration and number of visits needed. Research coordinator keeps track of all study related activities under the supervision of principal investigator. Studies are closed as per the protocol after completion of predetermined procedures for a set period of time. 

After the trial is finished, study sponsor will submit data and finding to the FDA. After careful review of data from clinical study, FDA will decide if the study drug can move to the next phase of testing or approved for the market use. 

What are the risks of a clinical trial participation?

Level of risk varies from peron to person and study to study. All research study drugs can potentiall have some element of risk becaue they are being tested and full health risks many not be entirely known. A physician will carefully go over any known or predictable risks or side effects during consent process. 

What are the benefits of a clinical trial participation?

Clinical trials offer opportunity to participate in development of new treatment options before they are available to general public. All study related assessment, treatment, medications and services are offered with no cost to study participants. Some studies may offer compensation for time and travel expenses during study participation. Most importantly, study participation gives gratification by contributing to scientific advancemeent and breakthrough inventions. 

What if I decide to drop out from study?

Study participation is completely voluntary. You are welcome to withdraw consent and drop out from study with or without a reason. There will be no penalty or cost dropping out at any stage of study participation. Your study coordinator can guide and recommend after care follow up if needed. 

What if I have a change in health status?

Notify your study coordinator or study doctor if there is a change in your health status while participating in a reasearch study. Reach out to nearest emergency room for any emergencies and inform the caring physician about your research participation. You can notify the study coordinator as soon as possible. 

What does it cost me to participate in a study?

There is no cost to you for participation in any research study. 

Do I need health insurance to participate in a study?

No. Most of the studies cover all study related assessments, lab tests, procedures and medications with no cost to you. Some long term naturalistic studies provide partial support to study related activities becaue they allow subjects to take their own standard treatment of choice. Your study coordinator can tell you about individual studies and participant expectations. 

What is an IRB and what do they do?

Institutional Review Board (IRB) is a committe of people who weigh the risks and benefits of a clinical study before approval. Their main mission is to protect human subjects by ensuring thath there are enough necessary safeguards in a study. IRB is composed of members from both scientific and no-scientific backgrounds. They follow the direction and guidelines from FDA and Department of Health and Human Services. All research related activities must be reviewed and approved by IRB before initiation. 

For any questions or concerns, contact:

Atlanta Behavioral Research, LLC

2150 Peachford Road, Ste. K

Atlanta, GA 30338

Tel: (770) 458-0447

Email: contact@abrtrials.com