What is a clinical research ?
There are two types, observational studies and clinical trials.
Observational studies observe people in normal settings. Researchers gather information, group volunteers according to broad characteristics, and compare changes over time. For example, researchers may collect data through medical exams, tests, or questionnaires about a group of older adults over time to learn more about the effects of different lifestyles on cognitive health. These studies may help identify new possibilities for clinical trials.
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.
Other clinical trials test ways to find a disease early, sometimes before there are symptoms. Still others test ways to prevent a health problem. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem. Clinical trials sometimes study the role of caregivers or support groups.
Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans. And these trials are done under strict guidelines and control.
What are the Four Phases of Clinical Trials?
Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.
Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.
A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
A Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
A Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
A Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug’s effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
If you want to participate in one of our clinical trials:
Call IMIC Medical Research Center for a discussion over the phone. Since 2009 our only focus has been to conduct FDA controlled studies on today’s incurable diseases with the cooperation of our medical partners. Call now to schedule a free evaluation and to see if you may qualify for one of our current studies.
Participants of our clinical studies and their doctors have a lot to benefit from. We compensate the patient and their doctors for working with us on future cures for today’s medical challenges.
Participants of our clinical studies receive free of cost:
- Medical evaluations
- Laboratory tests
- Study medication
- Compensation for time and travel
- Study related procedures.
Please contact us if you, a loved one or a family member suffer from the following conditions and may be a good candidate for medical research:
Asthma, Crohn’s disease, Ulcerative Colitis, Cirrhosis of the Liver, NASH, Fatty Liver, Alzheimer’s Disease, Agitation in Alzheimer’s Disease, Mild Cognitive Impairment, Tourette’s Syndrome, Bi-Polar Disorder in Adolescents and Adults within the Autism Spectrum
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