Therapeutic Research is the process of demonstrating that a new drug or the new indication for a medicine is safe and effective for treating human patients.
It is the longest and most expensive portion of the drug development cycle and can last between 2-10 years. The process is performed in a series of steps described in terms of phases:
The new drug is tested in small groups of healthy volunteers. These tests are primarily looking at the drug’s safety, but can also be designed to explore the drug’s behaviour inside the body, how it is absorbed, distributed, metabolised and excreted.
The main aim of Phase II trials is to assess a new drug for safety and efficacy and to determine the therapeutic dose. These trials are carried out in patients who have the disease for which the drug is targeted.
Phase III trials are the largest part of any clinical development program and may involve many thousands of participants. Phase III trials provide the majority of the safety and efficacy data about the drug.
Before the drug can be prescribed, all the data collected during all phases of development need to be assessed by the Regulatory Authorities. If they evaluate that the drug is safe and works, it will be granted a marketing authorisation.
Post authorisation trials can be further conducted to collect additional information on the safety of a new medicine and its optimal use. The Regulatory Authorities may request these studies as part of the granting of a marketing authorisation.
At Servier UK’s International Centre for Therapeutic Research (ICTR), we are currently involved in sponsoring, designing and managing clinical trials in their various phases in the following therapeutic areas: diabetes, oncology, hypertension, depression, schizophrenia, heart failure, stroke, osteoporosis and osteoarthritis.
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Last Updated 04/09/2008 14:07:00
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