
"Where Science Meets Innovation"
OUR TEAM
What is the difference between "research" and "medical practice?" Research is a way to answer questions and gain knowledge. We use that knowledge to come up with new treatments. Medical practice is a way to care for the health and wellbeing of patients. The main purpose of research is to test new scientific ideas or new treatments, which, if successful, may be used later in medical practice. Individuals participating in research may also be helped by it, but this isn’t always the case. What is a research study? A research study is a defined effort by doctors and scientists to investigate a research question. This effort includes the functions of study design, implementation, measurement and reporting. What is the difference between clinical research and other types of research? Doctors and scientists at HERCO are involved in many kinds of research studies. Some research doesn’t require human volunteers, which is referred to as nonclinical or preclinical research. Research that includes human participants is called clinical research. What is a clinical trial? A clinical trial is a common form of clinical research. It helps investigators understand how best to treat patients or helps them learn more about a particular condition or disease. Those trials may seek to discover new drugs, new ways of giving patients approved drugs or new combinations of approved drugs, as well as new surgical techniques, devices or biological products. Clinical trials are also conducted to test leading-edge and novel therapies, like studies that involve gene therapy or gene transfer. Clinical trials must be conducted before a new drug, biologic or device may be marketed in the United States. The Food and Drug Administration (FDA) regulates clinical trials. The FDA gives investigators permission to test a new drug, biologic or device under strict regulatory conditions. What are the different phases of a clinical trial? Clinical trials are conducted in phases. The trials at each phase have a different purpose and help researchers answer different questions. Phase I trial – The first evaluation of an experimental drug or treatment in a small group of people (20–80). The purpose is to evaluate its safety and identify side effects. Phase II trial – The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety. Phase III trial – The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects and compare it with standard or equivalent treatments. Phase IV trial – After a drug is licensed and approved by the FDA, researchers track its safety, seeking more information about its risks, benefits and optimal use. What are types of clinical trials? Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition. Natural history studies provide valuable information about how disease and health develop. Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning. Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness. Screening trials test the best way to detect certain diseases or health conditions. Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy