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Clinical Trials

Clinical Research

Atlanta Neuroscience Institute is committed to advancing medical knowledge and improving patient care through clinical research. Our clinical trials provide patients with the opportunity to access innovative treatments, new therapies, and cutting-edge medical advancements before they become widely available.
Participating in a research study helps our medical community discover better ways to prevent, diagnose, and treat diseases, contributing to breakthroughs that can benefit future generations.
Our experienced clinical research team ensures that every study is conducted with the highest standards of safety, ethics, and patient care. Participation is always voluntary, and each trial includes thorough medical oversight, education, and support throughout the process.

If you’re interested in learning more about our current clinical trials or finding out if you may qualify, please contact our Clinical Research Department at 404.351.0205 ext. 137

About ClinicalTrials.gov

What is ClinicalTrials.gov and who uses it?

ClinicalTrials.gov is a website and online database of clinical research studies and information about their results. The purpose of ClinicalTrials.gov is to provide information about clinical research studies to the public, researchers, and health care professionals. The U.S. government does not review or approve the safety and science of all studies listed on this website.
ClinicalTrials.gov:
  • Relies on sponsors or investigators to submit and update information about studies
  • Lists up-to-date information on clinical research studies and their results with new studies added almost every day
  • Includes studies that take place in all 50 states and over 200 countries
  • Supports laws, regulations, and policies that require sponsors and investigators to publicly share information about clinical trials, including results

What information about clinical studies can be found in the ClinicalTrials.gov database?

The ClinicalTrials.gov database includes information about clinical research studies that are happening now, will happen soon, or happened in the past. Information about each study is permanently available in the database, even after the study ends.
Information submitted about the study can be viewed in one place, called the study record. Each version of the study record is also permanently available. A study record includes:

General information about the study:

  • Study name and description
  • Person or organization responsible for the study (sponsor or investigator)
  • People or organizations that fund or provide support for the study
  • Disease or health problem studied
  • Start and end dates
  • Locations

Specific information about the study:

  • Who can and cannot join (eligibility criteria)
  • How many study participants are needed
  • A description of the intervention(s) that may be given (such as a drug, medical device, or behavior)
  • What researchers want to learn and how they will measure it
  • How to contact the study staff
  • Locations

Some, but not all, study records contain more information, such as:

  • What researchers learned from the study (results), including:
  • A description of the groups of participants who joined the study and their traits, like their average age – it doesn’t include any information that could identify an individual participant
  • Findings from the study
  • A summary of any health problems (adverse events) that happened during the study
  • The study protocol, analysis plan, and informed consent form

Clinicaltrials.gov general information

This page will help you understand clinical research, in general.
Choosing to participate in a study is an important personal decision. If you are considering joining a study, get answers to your questions and know your options before you decide. The NIH Clinical Research Trials and You website is a resource for people who want to learn more about clinical trials. It includes a list of what questions to ask if offered a clinical trial and can help you get information from the research staff to decide if you will join a study. You may also want to talk with your doctor and family or friends about deciding to join a study.
Learn about Studies

What is clinical research and why is it done?

Clinical research is medical research that studies people to understand health and disease. Clinical research helps improve the way doctors treat and prevent illness.
Through clinical research, researchers learn:
  • How the body works
  • How illness develops in people, such as how diseases get better or worse over time
  • How the body handles a possible treatment
  • Which behaviors help people stay healthy and prevent illness, and which behaviors raise the chance of illness
The goal is to use science to improve people’s health care and health over time. The participants who join and take part in clinical research studies may or may not get any benefit for themselves.

What are the types of clinical research?

There are 2 main types of clinical research: Clinical trials (also called interventional studies) and Observational studies.
Both may try to learn more about an intervention, which may be a drug, behavior, or medical device. The main difference is clinical trial participants are assigned to get an intervention, but observational study participants are not assigned to get an intervention.

Clinical Trials

Clinical trials are research studies in which researchers assign participants to get one or more interventions to test what happens in people. Because of this, clinical trials are also called interventional studies. Often, the intervention is investigational, which means it is not approved for doctors to prescribe to people.
In some clinical trials, researchers assign participants to interventions randomly. This means that researchers assign the participants by chance. Usually, participants (or their doctors) don’t choose what intervention they will get when they join a clinical trial.

Observational studies

Observational studies are research studies in which researchers simply collect information (called data) from participants or look at data that was already collected. The data may be about participants’ health, habits, or environments. In observational studies, researchers do not assign participants to get an intervention. If there is an intervention, participants were already using it as part of their regular health care or daily life.
Often, researchers use observational studies to look at (observe) the different ways people behave and how it affects their health. Some observational studies use patient registries. A patient registry is an organized collection of data that patients agree to give. Researchers can use a patient registry to quickly access data provided by hundreds, or thousands, of similar patients.

What happens during clinical research?

Clinical research relies on people who join. People who are thinking about joining a study get information about the study to help them decide. Research staff are available to answer their questions. This process is called informed consent. It’s the main way people get study information before deciding whether or not to join a study.
Informed consent is a process that includes a document that has important information about taking part in the study, including:
  • A description of what will happen during the study
  • Who can join the study
  • How much of participants’ time the study will take
  • Any payments and costs, such as payment participants get from taking part and any costs participants may need to pay
  • The known benefits and risks of taking part in the study
Other ways people can get information about a study may include:
  • Asking the research study staff questions
  • Reading brochures or websites
  • Watching videos about the study
If someone has discussed the study with the research staff, has had their questions answered, and agrees to join the study, they sign the informed consent form. Even if they sign the informed consent, they can leave the study at any time and for any reason. If they decide to leave, they can talk to the research staff to do so safely.
Clinical research happens in many ways, depending on the type of study. Studies can take place at hospitals, clinics, research centers, universities, over the phone, or on the internet. They may take a few days, weeks, or even years.
Researchers may assign participants into different groups. This happens in studies that compare an intervention to something else. For example, researchers may:
  • Compare 2 drugs to see which works better or has fewer unwanted side effects
  • Compare a drug to a placebo (a substance or treatment that looks like the drug, and is given in the same way, but has no active drug)
  • Compare getting a treatment to no treatment
Often in clinical trials, researchers assign participants into the groups at random (by chance). These participants may not know what group (or intervention) they have been assigned, and the staff may not know either. This is called “masking” or “blinding”. This ensures that participants and research staff do not know what intervention each participant receives to help make sure the results are looked at fairly.

Other Frequently Asked Questions

Who can join clinical research?
Researchers look for people who fit a certain description, called eligibility criteria. These criteria give details on who can and cannot join a study and could include:
  • People of a certain age or gender
  • People who do or do not have a certain illness, disease, or health condition
  • People with or without a certain health history, such as a prior treatment
  • People who are exposed to or are in contact with something that affects their health
Researchers use eligibility criteria to keep participants safe and enroll the right participants to collect the data they need to answer the research question. There are many kinds of research studies, all with different types of eligibility criteria.
Participants may or may not get any benefit themselves from joining a clinical research study. In clinical trials, researchers often don’t know if the intervention will be helpful, harmful, or the same as regular health care.
Some people volunteer to join clinical research to:
  • Help researchers learn about health, illness, or treatments
  • Be a part of discovering health information that may help others in the future
  • Possibly get a drug or medical device that is not yet approved to be used in people with a certain health condition
All studies involve some level of risk or harm to participants. Because of this, there are people and systems in place to look out for participants’ safety.
The possible risks of taking part in clinical research include:
  • The chance that participants will have a side effect or other health problem during a study (also called an adverse event)
  • Participants may not get the intervention being tested in a clinical trial – instead, they may get the standard treatment or no treatment at all
  • The intervention being tested may not work or may not work better than the standard treatment
  • The study may require more time and visits than their regular health care.
All clinical research involves some risk. Different kinds of studies have different amounts of risk to participants. For example, the amount of risk may be the same or different as participants’ regular health care.
In most studies, participants can keep seeing their regular doctors. If needed, the research staff will work with participants’ doctors to make sure that being in the study will not cause problems. In some studies, participants may have to change or limit their usual health care, such as stopping other medicines they take.
Research staff will explain what to do if participants have health problems during the study. Usually, research staff ask participants to report health problems to them right away. Research staff include doctors and nurses who will work with participants and the participants’ regular doctors to address the problem.
A group of experts may also oversee what is happening in the study. If they have a safety concern, they contact the researchers right away.
If very serious health problems happen to participants during the study, the researchers may stop the study.
Participants can choose to leave the study, called “withdrawal”, at any time and for any reason. If they decide to leave, they can talk to the research staff to do so safely.
During the study, researchers collect data from participants to help answer their research question. They do this in different ways, such as:
  • Surveys or questionnaires
  • Getting images, such as X-rays or MRIs
  • Taking measurements, such as height, weight, or blood pressure
  • Taking samples of participants’ blood or tissue to look at in a lab
Researchers may need to collect data from participants many times or only a few times.
Researchers analyze (study) the data they collect from participants based on the research plan to answer their research questions. Different countries have different rules about how researchers can use each type of data. The informed consent form describes what researchers plan to do with participants’ data.
After the researchers analyze the data and the study is complete, researchers can share the study results. Study results summarize group data collected from all participants. These results can be published in research journals, on the internet, and on ClinicalTrials.gov. In some cases, researchers may list data from individual participants, but not in a way that allows readers to identify the participant.
If the researchers tested a new drug or treatment that they want to make available to all patients, they submit the data and results from clinical trials to the FDA. Experts at the FDA will look at the data from the clinical trials and decide whether to approve the treatment for use in people with a certain condition.
Usually, researchers need many studies before changing the way doctors prevent and treat illnesses.
The sponsor oversees a study and may be:
  • An organization, such as a medical center or drug maker
  • An individual, such as a doctor
The sponsor may have another organization carry out the study on their behalf. The person leading a research study is called the principal investigator (PI). The PI is usually a medical doctor or another type of scientist. The PI typically works for the sponsor and leads a team of research staff that could include doctors, nurses, researchers, and technicians. The team of research staff may work at sites around the U.S. and other countries to carry out the research.
The funder is the organization that pays the costs of carrying out a study. The funder can be:
  • The U.S. government, or governments of other countries
  • Drug makers or other private companies (industry)
  • Medical centers
  • Universities
  • Charities or non-profit organizations
The informed consent form describes the study’s payment and costs. Some studies pay participants who take part, but the amount varies based on the study.
Many clinical studies pay for the cost of the intervention and any research-related tests and visits. Some studies may pay costs for research-related travel and lodging, such as costs for parking or meals. Participants, or their insurance companies, still have to pay the cost of their regular health care.
Expanded access is a possible way for a patient with a serious illness who is unable to take part in a clinical trial to get an intervention (such as a drug or medical device) that isn’t yet approved for treatment. Expanded access is not clinical research and is not available for all interventions being tested.
For patients who cannot join a clinical trial and have no other treatment options, expanded access may be an option.
The U.S. FDA regulates expanded access. Read more about expanded access on the FDA’s website.
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