Understanding Clinical Trials
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Clinical Trial (also called medical research, research study, or clinical research) is used to determine whether new drugs or treatments are both safe and effective. Many think that clinical trials are the first step in development of a novel drug/compound or treatment; as a matter of fact, it is actually the last stage.
Discovery, research and development of a new compound/ treatment generally begins in a scientific laboratory. After extensive experiment and testing and if promising result of a drug/treatment is obtained, scientist may further test them on animals. A clinical trial on human will be initiated only if further positive and even more promising results is obtained.
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Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question. Trials are in four phases, which are further explained in table below:
Phases of Clinical Trial
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Description
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| I |
Phase I studies are initial research to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients. Researchers often test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
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| II |
Phase II studies are controlled research conducted to evaluate the effectiveness of the drug or treatment for a particular indication(s) in patients with a specific desease or condition and to determine the common short-term side effects and risks. The patients are given various doses of the compound and closely monitored to compare the effects and to determine the safest dosing regimen.
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| III |
Phase III studies are designed to evaluate the overall benefit-risk relationship, and to confirm the safety and efficacy of a drug/treatment, and the dosage regimen chosen, in large numbers of patients with a specific disease or condition. Researchers may compare the safety and efficacy of the new drug/treatment to that of the commonly used treatments (or standard treatments). Information obtained from Phase III studies is used to determine how the new drug/treatment is best prescribed to patients in the future. The complete information available on the new product will be submitted to relevant Health Authorities for approval.
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| IV |
Phase IV studies take place after the drug has been approved for marketing. It is a Post-marketing studies to gather additional information on the drug's effect in various populations and any side effects associated with long-term use.
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