Clinical Trials New medicines are continually being developed for the treatment of disease. It is, however, a complex process with many stages of research and development before a new medicine can be used to treat patients. A promising new drug must be extensively investigated before it is considered safe for humans. Clinical trials play a vital role in the development of new medicines, and it is thanks to people volunteering for clinical trials, it is possible for them to be thoroughly investigated and for advances in medicine to be made. In Phase I trials, a drug is tested for the first time in a small group of healthy volunteers mainly to determine the early safety profile and to gather information on the pattern of drug distribution and absorption, metabolism, and other pharmacologic actions of the drug in the body. These studies are carried out at dedicated research facilities like the Chiltern Clinical Research Unit. In Phase II clinical trials, the drug is tested for the first time in patients with the actual disease condition of interest. In these types of trials, information is collected on the initial efficacy of the drug, its optimal dosage and further details concerning its safety. Phase II clinical trials are carried out at multiple investigator sites and are often international. Phase III clinical trials are large-scale, multi-center studies in many patients with the target disease. In these types of studies, gathering enough data to demonstrate the drug’s efficacy and further safety information statistically is essential. This information is required by the regulatory authorities, who will examine it in deciding whether to approve the new medicine in their country. Even after a drug has been approved, clinical studies continue to gather more information on the drug used in the general population. These studies are known as Phase IIIb or Phase IV clinical trials. They are structured to obtain long-term safety data on the drug in specific or additional patient populations, data for different formulations or even to gather economic information on the use of the new drug. Useful links Clinical Trials
Phase I Clinical Trials
Phase II Clinical Trials
Phase III Clinical Trials
Phase IV Clinical Trials
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