Research studies are clinical trials in which real people participate as volunteers. Clinical research studies (sometimes called trials or protocols) 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. Some of the research studies at NeuroTrials involve promising new treatments that may directly benefit patients.
Who can participate in research studies?
Almost everyone can participate in some type of research study. Even healthy people are needed for some studies. Each clinical research trial has its own eligibility criteria outlining who can participate. The criteria may include age, risk of the disease being studied, and any medications that you are currently taking. You should talk to your doctor or the person in charge of enrolling patients for the study to find out if you are eligible for a particular study.
Are research studies safe?
Risks are involved in clinical research, as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring. Most clinical studies pose risks of minor discomfort, lasting only a short time. Some volunteer subjects, however, experience complications that require medical attention.
An institutional review board (IRB) reviews the study for safety. Each study is evaluated by the IRB to determine that it complies with regulatory guidelines to ensure participant safety and well-being. The IRB is made up of members of the community. The IRB includes individuals not associated with NTR, including both medical and non-medical professionals.
NTR physicians and clinical staff review each study. Our physicians, practitioners and clinical staff have a significant amount of experience conducting clinical research. The specific risks associated with any research protocol are described in detail in the informed consent form (ICF), which you are asked to sign before taking part in research. In addition, 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 these risks.
Why join a research study?
There are many reasons why people volunteer to become part of clinical research trials. Some people volunteer because they may be helped by a new treatment or procedure. Others join because they want to help in the discovery of new treatments, procedures, or medications that may benefit patients in the future.
Clinical trials are a critical component in expanding treatment options for all diseases and disorders. Clinical trials rely on patient volunteers to investigate different ways to treat disease, using investigational drugs — also called study drugs — and experimental ways of giving drugs to determine if they are safe and effective.
Since all new therapies must be evaluated through research studies, the greater the number of people who participate, the faster emerging therapies can be brought to market. These trials also provide patients with access to therapies that are still in development, but might offer specific advantages for their particular issue.
How will my private information be protected?
Any information about you obtained from the research- including answers to questionnaires, medical history information, laboratory data, or findings from physical examination, biopsy, or surgery- will be kept confidential. You will not be identified by name in any report or publication unless you sign a release. Just like they can review hospital medical records, federal regulatory authorities may review your records.
What is informed consent?
The informed consent form (ICF) explains the study in detail, giving you information about the potential risks and expected benefits of the drug and a detailed description of the study process. You will have as much time as you need to review the ICF and information. We’ll also sit down with you and answer any additional questions you may have. Once you fully understand and are comfortable with the process, we’ll ask you to sign the ICF, indicating your willingness to participate in the study. After your ICF is completed, you will receive a copy.
What are my responsibilities during the study?
Participants must follow the instructions they are given. For example, you may be asked to refrain from caffeine or alcohol prior to or during the study. Most of the instructions are pretty simple. In general, you’ll be given the medication at the beginning of the study and then will be asked to provide blood and urine samples at regular intervals. You’ll be required to attend all study appointments and to keep in contact with the study physician or coordinator.
What does Phase I-IV mean?
Phase I studies assess the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally compensated for participating in the study. The study is designed to determine the effects of the drug or device on humans, including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.
Phase II studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second “control” group receives a standard treatment or placebo.
Often these studies are “blinded” which means that neither the patients nor the researchers know who has received the experimental drug. Blinding allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies. Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. Seventy to ninety percent of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.
Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug’s long-term effectiveness and impact on a patient’s quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.
What can I expect throughout my participation with NeuroTrials?
At NTR, we are always conducting new clinical trials and we always need new volunteers. If you’re interested in participating, please review our current studies. Even if we do not currently have a study for you, complete the pre-qualification form to submit your information entered into our patient database. As new studies begin enrolling, we will search our database for qualifying participants.
Your First Appointment
During the screening process, your safety is our primary concern. Before being accepted into any study, you will be given an informed consent form (ICF) to read and review, as well as other important information about the study. You will also complete a full medical history. Once you agree to the terms and conditions of the ICF, you will proceed to the lab work portion of the process where team members will measure your height, weight, temperature, blood pressure, pulse and ECG (electrocardiogram) and will collect urine and blood samples. This process usually takes 2-3 hours on average. Our study coordinator will give you a physical exam and will also answer any study-related questions you may have. The physical exam process takes approximately 30 minutes.
Upon completion of your initial visit, we will contact you within 2-5 business days with your results and inform you if you are accepted to the study. You will be provided a date and time for your arrival as well as special instructions and information to follow prior to your arrival.
Neurotrials Research, Inc. 5887 Glenridge Drive, NE Suite 400 Atlanta, GA 30328