Everything you Need to Know About Clinical Trials
Many people have of course heard about clinical trials, but some jump into the volunteer bandwagon without gathering enough information and details on the matter. A clinical trial is, at its core, a scientific and medical study used to define more practical and useful ways to prevent, diagnose or treat disease. They involve testing of the new treatment, often involving volunteers and the comparison of the new treatment to an existing one. Clinical trials are split into two different kinds of studies known as observational studies and interventional studies.
What is an Observational Study?
An observation study refers to the process of researchers following people (volunteers) over a course of time to determine certain health factors. This could be anything from testing what affects people’s hearts to ways in which people experience the aging process etc.
What is an Interventional Study?
This is a more personal study involving individuals who have been exposed to a certain treatment. Their reaction to this treatment is then closely followed by researchers during the clinical trial process. Examples include monitoring blood pressure and any possible side effects caused by the treatment currently being tested.
Clinical trials require professional Clinical Trial Assistants who are needed to assist the clinical team for certain areas such as project communications, correspondence and correct documentation. It can be easy to slip up on any of these areas, which is why hiring a professional from gandlscientific.com is strongly advised. These clinical trial assistants will accurately update and maintain clinical systems, allowing for perfect tracking site compliance and performance. Very few clinical trials are carried out without this kind of professional assistance.
Phases of Clinical Trials
According to the NIH Medline Plus, there are four phases of a clinical trial. The first involves experimental treatment on a small group of people. The second expands this further by testing on more people to find out its safety and effectiveness. Phase three is a much larger study and usually compares the treatment to a standard treatment. The last phase is the process of achieving approval from the FDA via the 510(k) clearance process. Once approved, the new treatment which had undergone the clinical trial can now be legally marketed as a safe and effective course of treatment, whether that be a new drug or device etc.