www.studysas.blogspot.com: Clinical Trails

Clinical Trails

Posted by www.sas9.blogspot.com on Thursday, December 27, 2007

Clinical Trials
A clinical trial is a research study designed to answer specific questions about new drugs, medical devices, or new ways of using known treatments. Clinical trials are used to determine whether the new drug or treatment is safe, and whether it works.

Clinical trials consist of four phases:

Phase I tests a new treatment on a small group, and concentrates on safety;

Phase II deals with safety and efficacy, and expands the study to a larger group of people (several hundred);

Phase III expands the study to an even larger group of people (thousands), and is designed to determine conclusively whether or not the treatment is effective;

Phase IV takes place after the drug has been licensed, to monitor the drug for long-term effects.

What are the phases of a clinical trial?

The randomized, double-blind, placebo-controlled (or active-comparator-controlled) trial offers the strongest evidence that a treatment is effective. The number of participants also considerably effects how reliably the trial can determine the effects of a treatment.
Clinical trials must be consistent with good clinical practice (GCP), a rigorous set of guidelines designed to protect the participants’ safety and the integrity of the trial data. The FDA requires pharmaceutical companies and contract research organizations to conduct rigorous clinical trials verifying the safety and efficacy of the new drugs before granting approval for marketing.

The trial objectives and design are usually documented in clinical trial protocols. Once the objectives are determined, case report forms must be carefully designed to gather complete, unambiguous data from the trial.

During the trial, the data management team must continually monitor and verify the data to ensure that they are accurate and consistent. Any missing or inconsistent data must be investigated and corrected.

This entry was posted on Thursday, December 27, 2007 at 1:21 PM. You can follow any responses to this entry through the RSS 2.0. You can leave a response.

# by Anonymous - January 7, 2008 at 9:14 PM

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# by Anonymous - January 8, 2008 at 1:03 AM

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# by Unknown - July 29, 2009 at 6:50 PM

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Thanks
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# by Unknown - July 19, 2010 at 12:57 AM

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# by Anonymous - October 18, 2010 at 1:39 PM

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# by Unknown - April 27, 2011 at 2:50 PM

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# by Unknown - May 16, 2011 at 6:18 PM

Hi Sarath,

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# by Mr,Nalimela - June 15, 2011 at 5:41 AM

Hi Sharath gi,
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# by dimple - November 29, 2011 at 11:56 PM

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# by dimple - November 29, 2011 at 11:57 PM

Hi Sharath,

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# by Anonymous - January 7, 2012 at 7:17 PM

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# by Anonymous - January 7, 2012 at 7:17 PM

Hello Sharath,

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Thank you,
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# by Anonymous - February 17, 2012 at 1:53 PM

Hello Sharath,

Please send me the ebooks. My email is alexey.pronin@uky.edu

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# by Anonymous - April 23, 2012 at 2:39 AM

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# by Unknown - November 25, 2012 at 10:46 AM

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# by Unknown - November 25, 2012 at 10:47 AM

hey sharath,

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# by Unknown - August 7, 2015 at 7:54 AM

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thanks

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