Pre-clinical (or laboratory) research
Clinical trials are only conducted once pre-clinical studies indicate that the new medicine or treatment is likely to be safe and effective in humans. Pre-clinical investigations, commonly known as laboratory studies, comprise the following:
• Cell studies: These are frequently the initial tests performed on a novel treatment. To see if it works, researchers examine the effects of the new medication on cancer cells cultivated in a lab dish or test tube. This research could be conducted on human or animal cancer cells.
• Animal research: Treatments that show promise in cell studies are then evaluated in live animals on malignancies. This allows researchers to determine how safe the new medicine is for a living being. Pre-clinical studies provide a lot of helpful information, but not all of it. Humans and mice absorb, process, and eliminate medications and therapies in fundamentally different ways.
A cancer treatment that works in mice may or may not work in humans. There could potentially be adverse effects and other issues that did not manifest in mice but could manifest in humans. If the pre-clinical investigations are done, and the treatment still appears promising, the US Food and Drug Administration (FDA) must approve the treatment before it may be tried on humans.
The application for an investigational novel drug (IND)
The research must be approved before a clinical trial may begin. When researchers want to examine medicine in humans, they must file an investigational new drug (IND) application or request with the FDA. The IND application must include particular details, such as • Study results, so that the FDA can determine whether the treatment is safe for human testing.
• Who makes the drug, what’s in it, how stable it is, and other details.
• Study protocols, which are detailed outlines for planned clinical research, are assessed to check if participants are being exposed to unnecessary hazards.
• Information about the clinical trial team to determine if they have the knowledge and skills to conduct clinical studies.
The research sponsor must commit to obtaining informed permission from all clinical trial participants. They must also agree to have the study examined by an institutional review board (IRB) and to follow all of the rules for researching investigational new medications.