Why clinical Trials are needed? Discuss while elaborating various phases of Clinical Trials.
Why clinical trials are needed
- To check if a new drug or device is safe and effective.
- To compare existing treatments and determine which is better.
- To study different ways to use already existing treatments to make them more effective and easier to use, and/or to decrease side effects.
- To learn how best to use a treatment in a different population, such as patients in whom the treatment was not tested previously.
Various Phases of Clinical Trials
There are six phases in clinical trials as follows:
- Phase-0: This refers to exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals. For example, screening studies, microdose studies.
- Phase-1: This refers to studies that are usually conducted with healthy volunteers and that emphasise safety. The goal is to find out what the drug’s most frequent and serious adverse events are and, often, how the drug is metabolised and excreted.
- Phase-2: This refers to studies that gather preliminary data on effectiveness [whether the drug works in people who have a certain disease or condition]. For example, participants receiving the drug may be compared with 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: This refers to studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
- Phase-4: This refers to studies occurring after the drug regulator has approved a drug for marketing. These include post-market requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drugs safety, efficacy, or optimal use.