Clinical investigation is one phase of the FDA new drug approval process that is used to bring a new drug to market, making it available for treatment in any patient. The process begins with laboratory research but must eventually include clinical trials before final FDA approval can be sought. Clinical refers to the inclusion of people as test subjects.

In the clinical investigation phase, the potential new drug is tested on patients. The drug has already shown promise in the lab and demonstrated to be reasonably safe for people. During the clinical investigation, people who meet certain criteria are given the drug and its effects are documented.

A clinical investigation usually consists of a series of tests with various human subjects. The tests are designed to simulate real-life disease treatment in realistic scenarios. In most clinical trials, a control group is used for comparison. The people who get the drug are compared to similar people who do not get the drug or who get the drug to see how it changes the progression of their disease.

How Is Clinical Investigation Regulated?

The FDA regulates all clinical investigations very closely to protect public health. A potential new drug must first undergo laboratory testing to demonstrate it is safe to use on people and that there is a reason to use it. If a drug does not show the potential for treatment benefits, it cannot move on the clinical trials, even if it is completely benign.

No clinical investigation can take place without clearance by the FDA of an IND application. Though there is a need to positively impact the disease and a rush to do so, especially in the case of life-threatening cancers, no purpose is served by endangering people in clinical investigations that are not properly regulated.

With respect to clinical investigations, the FDA manages rules governing the information a patient must receive when participating in clinical trials. The use of private patient information and bio specimens from trial participants and the storage and future use of such materials is also regulated by the FDA for the protection of patients.