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Medical research is vital to learning how to identify, prevent, and treat various diseases. In fact, knowledge gained from biomedical research studies conducted over the last 100-plus years has greatly improved human health and life expectancy. In addition, advancements made in research methodologies have enhanced the field of experimental medicine itself, leading to the discovery of new medicines and preventative measures. However, there are several different types of medical research, and each is represented by a specific set of ethical standards and protocols.
From a broad perspective, there are two primary types of medical research that serve as umbrella phases for more specific types of research. The first phase, known as pre-clinical research, aims to create a safety summary in connection with a health product or drug before being tested on humans. The next phase is clinical research, which consists of clinical trials to observe the overall safety of a product or medicine in humans, as well as efficacy. In addition, clinical medical research is largely comparison-based and driven by analyzing results initiated by the product or drug as opposed to a placebo.
Clinical trials can also be broken down by type, or phases, which is defined by the sampling size and duration of the medical research. For instance, phase I clinical trials typically involve less than 100 human subjects and run up to 12 months, while phase II clinical trials may include several hundred subjects and last up to 24 months. Finally, phase III clinical trials can involve hundreds or even thousands of people and last up to four years. Medical research that exceeds these numbers of subjects and study periods are referred to as observational studies. A prime example of the latter is the Framingham Heart Study, which has been tracking more than 5,000 men and women since 1948.
Other types of medical research target more specific issues relating to health. For instance, prevention studies seek to prevent illness by examining the role of lifestyle in the risk of developing certain diseases, such as heart disease, cancer, and diabetes. When it is determined that a lifestyle or behavior is a contributing risk factor, then intervention studies are often launched to look for ways that more positive habits may help to reduce this risk. Sometimes, risk patterns emerge across varying ethic groups or regional populations, which are identified by epidemiological studies.
Medical research studies take place all over the world, of course, but are regulated by the home government of the research facility or university. In the U.S., the Food and Drug Administration monitors research guidelines and procedures. In Japan, the regulatory authority is the Ministry of Health. In much of Europe, medical research is regulated by the European Medicines Agency.