Clinical Trials at Global Medical Institutes
What is clinical research?
Clinical research is a branch of healthcare science that determines the safety and efficacy of medications, devices, diagnostic products, and treatment regimens intended for human use in order to find a more advanced drug to either cure, prevent, or control a disease.
What is a clinical trial?
A Clinical Trial is a carefully designed study that involves volunteers who receive investigational treatments under close supervision by a physician and other research professionals. Pharmaceutical and biotechnology companies have developed these treatments and these companies have then selected physicians, also called investigators, who are qualified to conduct trials.
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Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following:
- Who is eligible to participate in the trial
- Details about tests, procedures, medications, and dosages
- The length of the study and what information will be gathered
A clinical study is led by a principal investigator (PI), who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.
Clinical Treatments Include:
Phases of a Clinical Trial
- In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Benefits of participation
- Play an active role in your healthcare.
- Gain access to research treatments before they are widely available.
- Obtain monitored medical care and physical examinations.
- Help others in the future by contributing to medical research.
- If you do not have health insurance, clinical trials are a way to receive study-related medical care free of expenditure.
How do clinical trials work?
Informed consent is the process of providing potential participants with the key facts about a clinical trial before they decide whether to participate. The process of informed consent continues throughout the study. To help someone decide whether or not to participate, members of the research team explain the details of the study.
Typically, clinical trials compare a new product or therapy with another that already exists to determine if the new one is as successful as, or better than, the existing one. In some studies, participants may be assigned to receive a placebo (an inactive product that resembles the test product, but without its treatment value). Comparing a new product with a placebo can be the fastest and most reliable way to demonstrate the new product’s therapeutic effectiveness.
Randomization is the process by which two or more alternative treatments are assigned to volunteers by chance rather than by choice. This is done to avoid any bias with investigators assigning volunteers to one group or another. The results of each treatment are compared at specific points during a trial, which may last for years. When one treatment is found superior, the trial is stopped so that the fewest volunteers receive the less beneficial treatment.
Single-or double-Blind Studies
In single-or double-blind studies, also called single- or double-masked studies, the participants do not know which medicine is being used, so they can describe what happens without bias. “Blind” (or “masked”) studies are designed to prevent members of the research team or study participants from influencing the results. This allows scientifically accurate conclusions. In single-blind (“single-masked”) studies, only the patient is not told what is being administered. In a double-blind study, only the pharmacist knows; members of the research team are not told which patients are getting which medication, so that their observations will not be biased. If medically necessary, however, it is always possible to find out what the patient is taking.
Without volunteers, many treatments we have today would not be available. Even Tylenol and Advil needed rigorous testing through clinical trials before they were approved by the FDA. Life-saving imaging techniques, such as, MRIs and PET scans, were tested on volunteers. Because of the importance of clinical research, many view those who volunteer as “medical heroes”. Volunteers enable medical professionals to fight against diseases that are huge threats to people all over the world.
Global Medical Institutes (GMI) is an Investigative Research Company which conducts Phase I-IV human clinical trials for the pharmaceutical, biotechnology and medical devices industry through our network of wholly-owned and affiliated clinical research facilities.
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