A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. Clinical research studies help researchers test whether a new potential medication is effective and safe for the general public. Clinical research studies are sometimes referred to as “clinical trials.” Both mean the same thing.
Reasons to participate in a clinical trial include access to new and/or alternative treatments, free medication, access to expert medical attention and even just the desire to leave a legacy by helping the advancement of medicine. For many trial volunteers, clinical trials are an opportunity to get a peek at upcoming, and in many cases, very promising medications and treatments.
The government has put in place strict guidelines and safeguards to protect those who choose to participate in clinical trials. Before a prospective treatment is tested on humans, it is thoroughly tested through laboratory and model studies to determine if it’s safe. The tests are run by health professionals and doctors according to strict rules set by the Food and Drug Administration (FDA).
While we conduct trials, and collect data for the pharmaceutical industry, our foremost concern is the health and safety of you, our research participants. We count on you to provide us with the feedback needed to pass along to the pharmaceutical companies that insures the new medications are safe, effective and side effects well known. Research participants are an essential part of the clinical trial process and we value your feedback and participation.
Participation in a clinical trial is voluntary, and you may withdraw from the study at any time. Your medical condition will be closely monitored throughout the study by experienced research staff and physicians. There are established safety parameters for each study.
Before new medications become available on the market, they must go through rigorous testing before being approved by the FDA (Food and Drug Administration). There are many stages before a drug can be approved including both lab, animal, and human testing. Our site specifically conducts trials with patients who are suffering from specific conditions to evaluate the overall safety and effectiveness of an investigational medication. Throughout the study, you will be seen regularly by our clinical research team. We will check your current health and medical history, provide instructions about the trial, and carefully monitor your health during your participation in the research study.
Informed Consent occurs before you participate in a trial to make sure you understand the study, have all your questions properly answered, and learn about your rights as a study volunteer. This process helps you decide whether you want to become involved in a study and if it is in your best interest.
As with most healthcare treatments, there are both benefits and risks to every clinical trial. At Clinical Trials of South Carolina, we strive to ensure that all risks are minimized to keep our volunteers healthy and safe. The risks associated with clinical trials may include:
- There may be side effects or adverse reactions to medications or treatments.
- The treatment may not be effective for you.
- The protocol may require a lot of your time for trips to the study site, treatments, hospital stays, or complex dosage requirements
Clinical trials are sponsored or funded by a variety of organizations or individuals, such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.
Funding for clinical research comes from both the federal government through the National Institute of Health (NIH) and from private industry, usually pharmaceutical and biotech companies. The sponsor of the research hires physicians to conduct the clinical trial.
A research team led by a doctor, known as the Principal Investigator, conducts clinical research studies. The team may also include nurses and research staff.
You can withdraw from a clinical study at any time and for any reason, even after signing the informed consent form. You also have the right to learn about new risks or findings that emerge throughout the study. If researchers learn that a treatment harms you, you will be immediately notified and withdrawn from the study.
No. Health insurance is not required, nor is insurance information collected.
No. All study related procedures and investigational medications are provided to you at no charge.
Most trials provide compensation for your time and travel expenses.
Each year, thousands of people volunteer to participate in clinical research studies. By volunteering, you might learn more information about your current medical condition and gain access to new research treatments before they are made available to the public. With the careful medical supervision promised to trial volunteers, you may play a more active role in your health care, and receive free study-related medicines and medical exams during the study. Your feedback could help others with similar medical conditions by contributing to medical research.
Throughout the study, you will regularly be seen by our clinical research team. We will go over your current health and medical history, provide instructions about the trial, and carefully monitor your health during your participation in the research study.
Eligibility criteria differs from trial to trial. The criteria includes factors such as a patient’s age and gender, the type and stage of disease, and whether the patient has had certain treatments or has other health problems. Eligibility criteria ensures that new approaches are tested on similar groups of people. This makes it clear to whom a clinical trial’s results apply. These criteria also are a safety measure. They ensure a trial excludes any people for whom the potential medication’s known risks outweigh any possible benefits.
The first step toward qualifying is to meet with our Research Coordinator. If you qualify, you will be asked to come to the office for a visit. There, you will receive a medical examination, and the Research Coordinator will review the Informed Consent document with you and answer any questions you may have. The time frame and requirements of the trial are explained.
During a trial, you can expect to be given the investigational drug, a placebo or a currently available treatment. You can also expect to be seen by both the doctor and research coordinator at each visit. Study coordinators and physicians closely monitor the participants throughout the study via physical exams, laboratory tests and other medical procedures. Often, these procedures are described as an extension of what is traditionally done to manage the patient’s health and medical condition. Patients in research studies receive study medication, tests and exams at no charge throughout the course of the study. Studies can last for weeks, months or even years, during which time patients can save the enormous cost associated with paying for medications and office visits.
At the end of each trial you should expect to return any unused study drugs, and you will be asked to complete a short questionnaire about your experience. Your input may be put on our website.
We evaluate each patient individually to ensure you are a qualified candidate. Our doctors will collaborate with your doctors to make sure a clinical research study is the right path for your medical care. After a thorough review of your medical history and an evaluation of your lab work, one of our doctors will talk with you and decide if a trial is in your best interest.
You can leave the study at any time, for any reason. The Informed Consent form is NOT a contract. If you plan to stop participating, please let the research team know why you are leaving the study, so our office can fill out the proper paperwork for our files.
Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
Screening trials test the best way to detect certain diseases or health conditions.
The clinical testing of experimental drugs is normally done in three phases, each successive phase involving a larger number of people. Once the FDA has granted a New Drug Approval (NDA), pharmaceutical companies also conduct post marketing or late phase III/IV studies.
Clinical studies are done in a series of four different phases:
Phase I: These studies are primarily concerned with testing the drug’s safety in human volunteers. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study. About 70 percent of experimental drugs pass this initial phase of testing. During this phase, scientists find the best way to give a new treatment, how much they can safely give, and to identify side effects.
Phase II: In Phase II Studies, researchers try to see how well the product works against the disease and to further evaluate the treatment’s safety. This phase lasts from several months to two years. It involves up to several hundred patients (100-300) that have the disease that the product is going to treat. Most of these trials are randomized, i.e. the patients are randomly assigned (similar to flipping a coin) to a “control” group who will receive a standard treatment or placebo (sugar pill). Trials are also typically “blind,” meaning neither the patient nor the physician knows which group the patient has been assigned to. This is done to remove any bias the patient or the physician might subconsciously develop in assisting the patients.
Phase III: In a phase III study, a drug is tested in several hundred to several thousand patients. This large-scale testing tries to provide the drug company with a more complete understanding of the drug’s effectiveness, benefits and range of possible side effects, compares it to commonly used treatments, and collects information that will allow the drug or treatment to be used safely. Once a phase III study is successfully completed, the drug company can request FDA approval for marketing the medicine.
Post-Marketing – Late Phase III/IV: In late phase III/phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to monitor a drug’s long-term effectiveness and impact on a patient’s quality of life; and (3) many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.
All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness.
If you would like more information about participating in a clinical trial please contact our office at (941)727-7772, and a member of our research team will be happy to assist you.
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