According to the National Institute of Health, the types of medical studies performed by researchers are separated into two main categories – observational studies and clinical studies.
A medical observational study is much like it sounds. It is the study by a researcher through observation. In an observational study, individuals are studied without experiments or new test treatments. They are simply observed and assessed for the purpose of achieving a better understanding of a condition or disorder.
General types of observational studies may include case control studies, which compare a group of individuals who have a condition to another group of individuals who do not have that condition. Case control studies may be used for such purposes as uncovering risk factors of a condition, discovering the causes of a condition or identifying strengths and weaknesses across a certain population or demographics as it relates to the condition. Observational studies also include ecological studies, which compare groups of people who may be of different ages, economic backgrounds, races or geographic location, etc.; cross-sectional studies, which explore a condition across many individuals, at just one particular time; and cohort studies, which are studies in which a large group of individuals are observed and assessed over an extended time period. This type of observational study can, for instance, bring certain details to light about the progression of a disorder. To provide even further perspective, specific examples of observational studies might include sleep disorder studies, studies researching communication issues, seizure studies, motor skill studies and fine motor skill studies.
Clinical trials are typically used by researchers to perform actual tests in hopes of discovering detection, prevention and/or treatments. For example, a clinical trial may be used to investigate a new drug, a combination of drugs used to treat a condition or a drug which was previously used for one condition to treat a different condition.
Clinical research is also an exceptional means to test new technology and devices, such as medical testing equipment and products within the medical industry, like Smartwatches and remote medical tools; as well as new medical testing approaches and even the evaluation of medical care.
Clinical trials are often required before government approval is granted for new treatments and medical practices. Depending upon certain criteria such as the particular condition, population and previously acquired knowledge, more or less phases of clinical study may be required.
However, there are typically four clinical trial study phases, the first of which is used primarily for safety research – to determine if new drugs or devices are safe for use, how well they will be tolerated by individuals and what potential side effects they may cause. The first clinical trial phase is also used to gain a better perspective of proper medication dosage and appropriate application of new medical technology. Phase two of clinical trials ramps things up a bit with more testing for side effects, feasibility and monitoring on a larger group of individuals. Phase three further increases the number of individuals tested to the point where statistical significance is reached with regard to efficacy. It is also the point at which government approval is considered. Phase four of a clinical trial is put into place, after Food and Drug Administration approval and during the marketing process, when the treatment is available to the public for the purpose of continual, ensured safety.
As with observational medical studies, when a clinical trial has reached its conclusion, researchers carefully review the study information collected. Reviews are also conducted throughout the phases of a medical clinical trial to determine if that study is safe and viable enough to continue.
As we all have become painfully aware, clinical trials are used to test new vaccines, but they have also been utilized throughout history for everything from discovering a correlation between smoking and lung cancer, to pre-market approval on medical items ranging from urinary incontinence management, to aortic and aneurysm repair devices.
One of the most famous clinical trials is the one that was believed to be the first to have used control and placebo groups and, subsequently, demonstrated the importance of controlling variables while conducting a medical trial. This was the scurvy clinical trial of 1747 conducted by Scottish Surgeon and Royal Navy Member James Lind, who believed that citric acid could prevent scurvy. Dr. Lind put his theory to the test on 12 sailors with similar disease symptoms, who he separated into 6 pairs. He kept their diets consistent except for the introduction of oranges or lemons. The result was that there were “sudden and visible good effects” in the sailors who were given citrus.
Clinical trials were also famously used in birth control clinical research of the 1950s, in the discovery of the first cancer drug, for plaque psoriasis, peanut allergy therapy and so many more.
In summary, both observational and clinical research can be used for all types of research in many varying degrees of size and scope, and both can be used to prevent illness and improve overall quality of life. The key difference in observational and clinical studies is that in observational medical studies, hypotheses are drawn solely from observation and assessments. If a researcher within an observational study were to do anything other than observe, that interference could be considered data manipulation – negating the study. Conversely, researchers within clinical trials may gather data by using actual treatment and testing techniques.
Medical research is conducted at Velocity Clinical Research to improve diagnosis, prevention, treatment and lives. If you are interesting in playing a vital role in the advancement of medicine or you would simply like to learn more, you are welcome to call us at 386-428-7730 Monday through Thursday from 7 a.m. to 5 p.m. or Friday from 7 a.m. to 4:30 p.m.