Clinical Trials

What are clinical trials?


Clinical trials are clinical research studies conducted to investigate new treatments such as a new drug compound in human volunteers or research participants. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

Such research takes a cautious and progress in a sequential or phase approach. Research is conducted into new medications or therapeutic goods but can also involve products that are already available on the market, for further improvement.

Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.


Different phases of trial:


Phase 1

A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug’s most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.


Phase 2

A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug’s effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Phase 3

A phase of research to describe clinical trials that gather more information about a drug’s safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Phase 4

A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug’s safety, efficacy, or optimal use.