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Introduction to Clinical Research- session
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What is Clinical Research ?
What are Clinical Trials?
Clinical trials are a set of procedures in medical research conducted to allow safety and efficacy data to be collected for health interventions.
• Research studies involving people
• Try to answer scientific questions and find better ways to prevent, diagnose, or treat disease
• Translate results of basic scientific research into better ways to prevent, diagnose, or treat disease
Different Phases of Clinical Trials
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
¢ In Phase I trials (Human Pharmacology Trials), researchers test a new drug or treatment in a small group of healthy people ( 20 -50) for the first time to evaluate its safety, determine a safe dosage range.
¢ In Phase II trials (Therapeutic Exploratory Trial) the study drug or treatment is given to a selected group of patients (100 – 300) to see if it is effective and to further evaluate its safety.
¢ In Phase III trials (Therapeutic Confirmatory Trial) , the study drug or treatment is given to a large group of patients ( 1000 – 3000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
¢ In Phase IV trials (Post Marketing Surveillance) studies delineate additional information including the drug’s risks, benefits and optimal use.
What are Clinical Trials?
Clinical trials are a set of procedures in medical research conducted to allow safety and efficacy data to be collected for health interventions.
• Research studies involving people
• Try to answer scientific questions and find better ways to prevent, diagnose, or treat disease
• Translate results of basic scientific research into better ways to prevent, diagnose, or treat disease
Different Phases of Clinical Trials
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
¢ In Phase I trials (Human Pharmacology Trials), researchers test a new drug or treatment in a small group of healthy people ( 20 -50) for the first time to evaluate its safety, determine a safe dosage range.
¢ In Phase II trials (Therapeutic Exploratory Trial) the study drug or treatment is given to a selected group of patients (100 – 300) to see if it is effective and to further evaluate its safety.
¢ In Phase III trials (Therapeutic Confirmatory Trial) , the study drug or treatment is given to a large group of patients ( 1000 – 3000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
¢ In Phase IV trials (Post Marketing Surveillance) studies delineate additional information including the drug’s risks, benefits and optimal use.
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