Clinical Trials and Studies come under the broad category of clinical research that is nothing but medical research involving people. The main difference between clinical studies and trails is that the studies take place in normal settings and the result are based on information collected from the observations; whereas, trails are interventional studies that are conducted to evaluate a new drug, medical device, procedure, or treatment.
With the increasing demand for new drugs, treatments, procedures, and devices; the demand for clinical research services has increased and this is how the clinical research organizations came into existence. The clinical research organization is known to provide end-to-end clinical research services and serve different kinds of clinical research like Treatment, Prevention, Diagnostic, Screening, Quality of Life, Genetic, and Epidemiological. All these studies are conducted in different phases, with each of them having a different purpose with the ultimate aim being approval of the drug/device/procedure/treatment for human use.
- In order to gain approval from FDA to begin the actual clinical trial, it is necessary that appropriate laboratory tests and animal testing is conducted by scientists who have the expertise. Only if the results of these tests are positive, the FDA allows further testing that involves humans.
- The next step is called a Phase I trial. This phase involves the testing of safety, side effects, and the correct drug dosage on a small group of healthy people, approximate 20 to 80.
- Next follows the Phase II trial that involves 100 to 300 people who have the disease or condition for which the drug is being tested. This phase emphasizes both, the safety as well as efficacy. This phase is known to last for a long time as the drug is also tested for side effects.
- The aim of Phase III study is the same as Phase II; however, it involves a large and diverse population (100 to 3000 people). This phase also involves testing different dosages of drugs and in combinations as well.
- Phase IV is the post-marketing phase, where the drug or device is monitored for its safety and efficacy for a long duration. This helps to keep a tab on any side effects which have not been observed previously.
To conclude, it is very important that each and every step is followed by the clinical research organization providing clinical research services as it involves human interventions and ultimately meant for use by humans.