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

hey sharath,

This is a great resource for SAS. Lot of valuable information. Can you please send the ebooks. My mail id is
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Thanks,
Sailaja

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

hey boss,
this blog is the gr8 one to find sas books very easily through ...but could u plz send me the total ebooks u have...plz forward to my mail id deepak_posa@yahoo.com or deepakposa@gmail.com
plz do favour about sample resumes too....thanks a lot boss.

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

Hi Sharath,
this is a very effective tutorial on SAS.Would u mind to send the ebook?
email id aditidey12@gmail.com

Thanks
Aditi

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

hi sir,
This is Anil Paradesi.Can you please send the ebooks. My mail id is
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Thanks,
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# by Anonymous - October 18, 2010 at 1:39 PM

Hello Group,

This is very informative , can you send me the ebooks to kk_mba@yahoo.com

# by Anonymous - February 12, 2011 at 12:43 PM

hey sharath,

This blog is gr8 and useful for all sas users. I really appreciate ur work. Can you please send the ebooks @ ursangelforever123@yahoo.com

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

Hey group,

This blog is very helpful, can you pls forward me the ebooks you have to my mail id.
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Thanks,
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# by Unknown - May 16, 2011 at 6:18 PM

Hi Sarath,

Really a gr8 source for SAS. Can you pls send the ebooks to madhavi.a99@gmail.com

Thanks,
Madhavi

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

Hi Sharath gi,
this is a very effective tutorial on SAS.If possible plz can you send the e.book to my mail .
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Thanks

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

Hi Sharath,

This blog is very useful for me, can you please send me the ebook to dimple_smarty1987@yahoo.com

Thanks
dimple

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

Hi Sharath,

This blog is very useful for me, can you please send me the e book to my email ID - dimple_smarty1987@yahoo.com

Thanks
Dimple

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

Hello Sharath,

Great blog, very informative. It would be great if you can forward me the e-books if any available @hkkoyyada@gmail.com

Thank you,
Prathibha

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

Hello Sharath,

Great blog, very informative. It would be great if you can forward me the e-books if any available @hkkoyyada@gmail.com

Thank you,
Prathibha

# by Anonymous - January 20, 2012 at 1:34 AM

Hello sharath,
This's great resource for sas. can you please send ebook to my email .....
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thanks.

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

Hello Sharath,

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

Thanks,
Alexey

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

Hi, I am now studying SAS, and this one is quite useful for me, could you please send the ebook to me?

My email is dreamfield88@hotmail.com

thanks!

# by JRB - May 15, 2012 at 12:11 PM

Hi Sharath,
Thanking you for all the effort and helping others in SAS. Request you to forward ebooks on cts185471@gmail.com

Regards
Jayesh B.

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

may I have the ebook? email id:
hulindsay6@gmail.com

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

hey sharath,

This is a great resource for SAS. Lots of valuable information. Can you please send the ebooks to me?

My mail id is hulindsay6@gmail.com

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

Thanks a lot for the information, you provide on the SAS Clinical Trails

# by Unknown - January 8, 2016 at 2:35 AM

this is a great reference website for sas learners,lots of useful content is avaialabe here for learning sas,you are doing a great job by helping people who want to learn sas.thanks a lot for putting up this information on your website.i would be greatful to you if you could mail me the ebooks.Thankyou

# by Unknown - January 8, 2016 at 2:39 AM

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# by Anonymous - June 20, 2016 at 10:02 AM

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# by Anonymous - December 1, 2017 at 9:09 PM

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This is very resourceful site to learn about clinical trials. Can you please send me ebooks for clinical sas to my mail id: smp.now2017@gmail.com

# by Ishu Kutty - February 22, 2018 at 8:12 AM

Hi..

Wonderful site.. Very informative... Can you please send me the ebooks for clinical sas to my email id: geethasiva.bala@gmail.com

thanks

# by Anonymous - November 2, 2018 at 1:16 AM

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# by Unknown - January 25, 2019 at 8:59 PM

It is very useful to learn sas. Please send me ebooks, email: utchunliyan@gmail.com
thanks,

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Great Blog. Thank you for sharing this information about pharma clinical trails

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