Clinical Trials

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Clinical Trials involve the following Phases
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'''Clinical Trials''' are conducted to determine whether new drugs or treatments are both safe and effective.
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Testing in Humans
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Clinical trials help physicians discover the answers to the following questions:
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<table align ="center "><tr><td></td><td>Number of Patients</td><td>Duration</td><td>Purpose</td><td>Percent of Drugs Successfully Tested</td></tr>
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<tr><td>[[Phase I]]</td><td>20 - 100</td><td>Several months</td><td>Mainly safety</td><td>70 percent</td></tr>
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1.Is the treatment safe and effective?
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<tr><td>[[Phase II]] </td><td>100 - 500 </td><td>Several months to 2 years</td><td>Some short-term safety, but mainly effectiveness </td><td>33 percent</td></tr>
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2.Is the treatment potentially better than the treatments alredy existing?
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<tr><td>[[Phase III]] </td><td>1000 - 8000 </td><td>1 - 4 years </td><td>Safety, effectiveness, dosage </td><td>25 - 30 percent</td></tr>
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3.What are the side effects of the treatment?
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<tr><td>[[Phase IV]]</td></tr></table>
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4.Does the treatment have any possible risks?
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5.How well does the treatment work?
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==Types of Clinical Trials==
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*'''Treatment trials :''' test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
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*'''Prevention trials :''' look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
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*'''Diagnostic trials :''' are conducted to find better tests or procedures for diagnosing a particular disease or condition.
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*'''Screening trials :''' test the best way to detect certain diseases or health conditions.
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*'''Quality of Life trials (or Supportive Care trials) :''' explore ways to improve comfort and the quality of life for individuals with a chronic illness.
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==Phases of Clinical Trials==
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Clinical trials are conducted in four different phases. The trials at each phase have a different purpose and help scientists answer different questions.
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In '''Phase I trials''', researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
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In '''Phase II trials''', the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
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In '''Phase III trials''', the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
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In '''Phase IV trials''', post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
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{| border="1;width:100%; height:200px;style=text-align:center"
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|+'''Table I:'''
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|+'''Phases of Clinical Trials'''
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|-
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! style="background:brown; color:white" |Phases
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! style="background:brown; color:white" |Number of Patients
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! style="background:brown; color:white" |Duration  
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! style="background:brown; color:white" |Purpose
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! style="background:brown; color:white" |Percent of Drugs Successfully Tested
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|-
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| Phase I
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| 20-100
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| Several Months
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| Safety
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| 70 %
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|-
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| Phase II
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| 100-500
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| Several months to 2 years
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| Efficacy
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| 33 %
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|-
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| Phase III
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| 1000-8000
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| 1-4 years
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| Safety, Efficacy and Dosage
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| 25-30 %
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|-
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| Phase IV (Post-Market Survelliance)
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| -
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| -
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| drug's risks, benefits, and optimal use
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| -
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|-
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|}

Revision as of 07:25, 6 August 2008

Clinical Trials are conducted to determine whether new drugs or treatments are both safe and effective.

Clinical trials help physicians discover the answers to the following questions:

1.Is the treatment safe and effective? 2.Is the treatment potentially better than the treatments alredy existing? 3.What are the side effects of the treatment? 4.Does the treatment have any possible risks? 5.How well does the treatment work?

Types of Clinical Trials

  • Treatment trials : test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
  • Prevention trials : look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
  • Diagnostic trials : are conducted to find better tests or procedures for diagnosing a particular disease or condition.
  • Screening trials : test the best way to detect certain diseases or health conditions.
  • Quality of Life trials (or Supportive Care trials) : explore ways to improve comfort and the quality of life for individuals with a chronic illness.


Phases of Clinical Trials

Clinical trials are conducted in four different phases. The trials at each phase have a different purpose and help scientists answer different questions.

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

Table I: Phases of Clinical Trials
Phases Number of Patients Duration Purpose Percent of Drugs Successfully Tested
Phase I 20-100 Several Months Safety 70 %
Phase II 100-500 Several months to 2 years Efficacy 33 %
Phase III 1000-8000 1-4 years Safety, Efficacy and Dosage 25-30 %
Phase IV (Post-Market Survelliance) - - drug's risks, benefits, and optimal use -
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