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Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relief of symptoms in a disease.
Overview
The term clinical research refers to the entire biography of a drug from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the drug including its efficacy and toxicity are studied.
After this, the data obtained from the studies are submitted as an IND (Investigational Drug Application) to the regulatory authorities for permission to conduct human studies.
Human studies or the actual clinical trials are conducted in four phases. The first phase usually deals with the trial of the medicine in a few people, usually healthy volunteers. This is mainly targeted at identifying the safety, tolerability, and the general mechanism of action of the drug in humans. These are conducted in special places called CPUs (Central Pharmacological Unit) where participants receive 24hr medical attention.
The second phase usually deals with a population of about 50-500 people. This is an efficacy study. Also, the dose needed for the next phase is finalised. It is conducted in hospitals.
The third phase usually deals with the trial on more than 1000 patients. This phase is usually multi-centric and focuses on the effects on drugs in different ethnic groups, comparison with the standard drugs on the market and also study of the effect on the drug on different variants of the disease. Then, an NDA (New Drug Application) is filed to the regulatory authority containing the study data regarding permission to market the drug.
The fourth phase is usually conducted after the launch of the drug on the market. The aim is to identify newer and hitherto unknown adverse reactions, effects in different ethnic groups and newer therapeutic indications among others. The entire journey of a drug from lab to market may take approximately 12-18 years.
However, clinical research does not stop here. It continues throughout the lifetime of the drug to include post marketing surveillance where a periodic 'progress report' is submitted to the regulatory authorities once every 2 years after the drug is released into the market and also into Pharmacovigilance where safety of marketed drugs, biologics or medical devices are monitored.
The focus of clinical research is wide enough to include data management, medical writing, regulatory consultation, biostatistics to name a few.
The clinical trials are usually guided in the United States by the guidelines of the U.S. Food and Drug Administration and in the European Union by the European Medicines Agency.
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- This page was last modified on 7 October 2008, at 13:46.
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